ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES
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ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES P R O F. D O T T. E M M A N U E L U D E M E Z U E O N Y E K W E L U . CSci,CSciTeach,ChirB(Hons),MB(Hons)MD,MRQA,FRSA,FCILED,FRGS,FRSH,FRCEM,FRSPH,FRSB,DSc/PhD(Hon) CLASSICS AND REVISITS IN SCIENTIFIC MEDICINE 2024. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES TEXT Context and Essence. Fairly recently, the fields of Gerontology (the scientific study of aging) and Geriatrics (the science of the medical care and treatment of the elderly) has seen a growing interest on the research aimed to produce ideal candidate anti-aging agents (senolytics) The explosion of multiphased experimental translational research on senolytics demonstrates the heightened recognition by multidisciplinary scientists of the importance of sustaining the crucial advisory, role-modeling and mentorship roles of the elderly in the academia,industry,family(nuclear and extended), community levels and the society at large, in addition to the global levels. .(Onyekwelu.E.U.2020) For a long time, many extant and modern thinkers, have argued and demonstrated that the omission of these pivotal roles of the elderly in any given setting or anthropological unit will have a far wider negative connotation and impact on the cultural,traditional,technological,psychological,moral,scientific and holistically in several other aspects of development for the contexual setting.(Onyekwelu.E.U.2020) Axiomatically, the rational for the employ of senolytics is obvious, in that it will complement and support the natural physiological aging processes. If it is considered worthwhile and beneficial, that several other physiological processes such as teething, tooth shedding, childbirth,growth,menarchy and especially other specific aging processes such as osteopenia,osteoporosis and menopausal symptoms, could be supported medically,then what is the anomaly in supporting physiological aging to be a healthy aging process as well. Clearly, there are other pathological aging conditions in infants,children,adolescence,adults and the middle aged, which are associated with premature senescence related morbidities and mortalities. These earlier onset idiopathic senescence are specific instances, where senolytics could certainly be non-contenscieously indicated in order to circumvent the untoward influence of unprecedented aging such as earlier onset dementia, Alzheimer’s disease, arteriosclerrosis,metabolic syndromes(diabetes mellitus,hypertension,hyperuricaemia) etc. As a selected group, children with the Progerias,the Hutchinson-Gilford progeria syndrome (HGPS),the Cockayne syndrome, the Werner’s syndromes and some subset of the aneuploidies especially the Trisomy 21 etc,(Onyekwelu E.U 2020) could be potential bonafide candidates for senolytics derived therapeutics or its related pharmacotherapeutics such as Taurine. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Senolytics are pharmacotherapeutic agents that systematically and strategically get rid of, jettison and clear senescent cells rendering them amenable to programmed cell death and phagocytosis. The foundational processes of the identification, discovery and development of the index senolytic drugs such as Dasatinib, Quercetin, Fisetin and Navitoclax were achieved following a clearer comprehension and elucidation of the aetiopathophysiology and the causal-pathway of senescence, and attempts at their interruptions employing multiple therapeutic, prophylactic, diagnostic and integrative targets. At the first instance these attempts were somewhat challenging and daunting, given that the senescent cells, which crowds up exponentially with the aging process were destructive, ubiquitous, comparatively recalcitrant to programmed physiological cell death and are extensively distributed to several vital cells, tissues and organ systems of Homo sapiens and mammalian animal systems etc. Senolytics, putatively undermine the strengths of these evasive and invasive multipathogenic mechanisms. Across several experimental, preclinical animal test system models, it has been demonstrated that as a group, senolytics postpone, circumvent, and ameliorate senility and mutisystemic organic pathologies which are debilitating and fatal co-morbities of senescence However, besides the concerns of real time efficacy, there are several previous and ongoing concerns about the instantaneous and prospective toxicity profile of the recognized senolytics. As a group these putative senolytics are thought to be ‘unnatural’, since unlike Taurine, they are not significantly produced by the cells, tissues and organ systems of Homosapiens or closely related animal species. This is where the use and exploitation of the administration of exogenous molecules thought to be and demonstrated to be wholely and partly endogenously produced by the cells, tissues and organ systems of Homo sapiens such as Taurine comes in. Admittedly on the basis of the available reports and research on this theme, putatively, taurine has been elucidated to possess a significant free radical mopping up antioxidant property, an anti-inflammatory impact, and anti-aging and its comobidity chemical chaperone properties , with significant positive implications for delaying cellular,tissue,and organ systems autophagy and senescence on several subsets of experimental rodent animal test systems models(as has been demonstrated in this given index scientific research article),which has been partly translated to Homo sapiens through some concluded and ongoing human clinical research trials . (Singh, P. et al. 2023) ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES To date only very few gastrointestinal and hepatic side effects such as anorexia, nausea, flatulence, epigastric pain, vomiting and diarrhea has been reported to be associated with the consumption of Taurine in large pharmacological doses. Since these side effects were equally very frequent with even the most basic over the counter pharmacotherapy also, therefore in this context, would not be of much consequence with regards to Taurine. The overall objective of my innovative annotation and commentary is to recapitulate the positive beneficial effect and the chemical chaperone impact of Taurine on healthy aging and other senescence related co-morbidities. THE BIOLOGY, PHARMACOLOGY AND THE SCIENTIFIC FRAMEWORKS FOR THE BENEFICIAL ROLE OF TAURINE AS AN ANTIAGING AGENT. Anecdotal evidence proposes, that Taurine may fortify the Homo sapiens organ systems antioxidant derived free radical (which accumulates with aging) preventive and mopping-up properties and therefore reduce the acceleration of senescence in Homo sapiens and other mammalian species. Additionally, Taurine, ameliorates the tendency of aging associated, initiating, propagating, complicating, and sustaining co-morbidities such as, but not confined to arteriolosclerosis, diabetes-mellitus, high blood pressure, in addition to other microvascular and macrovascular ,renovascular,cerebrovascular,cardiovascular and pulmonary vascular pathologies etc. (Singh, P. et al. 2023) THE ETHYMOLOGY, THE BIOLOGICAL AND PHARMACEUTICAL PROPERTIES OF TAURINE. Ethymologically,the nomenclature Taurine was coined from the Latinised word Taurus, which has its ancient Greek colorate as (ταῦρος, “taûros”) meaning bull or ox: infact,Taurine was initially identified and extracted from the bile of the ox, named Bos taurus, in 1827 by the German scientists Leopold Gmelin and Friedrich Tiedemann (Tiedemann F., Gmelin L,1827,p.). Histriographic scientific studies focused on the presence of Taurine in animal tissues, where it was found in high concentrations in the brain, heart, and skeletal muscles. Later on, two decades after its discovery in 1846, the English chemist Edmund Ronalds observed and reaffirmed the presence of Taurine in human bile (Ronalds, E, 1846,P.281- 295). ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Previously in the course of my research on neonatal icterus,I had speculated that the physiological jaundice of the newborn, is physiological in that the abundance of bile in the blood stream (which causes and exposes the greenish yellow hue of the Jaundice in the early neonatal period is thought to assist and facilitate the physiological mopping up of the free radicals from the reactive oxidative species molecules, which accumulated perinatally, given that bile is embellished with Taurine.(Onyekwelu,E ,2017,29-305) Taurine is identified in huge amounts and concentrations in tissues and organ systems with very high oxidative respiratory quotients , endowed with an abundance of the mitochondria organelles(the energy station of the body). Biologically, taurine is categorized as a beta-amino acid. Biochemically, Taurine is characterized by an amino group (NH2), a carboxyl group (COOH), and a sulfonic acid group (SO3H), which are nested to the beta carbon. However, peculiarly, Taurine has no enantiomers, which are superimposable, whereas other amino acids have other superimposable mirror images. Taurines comparatively basic simplistic unique molecular chemical structure facilitates it to structurally and physiologically closely fit in to undertake numerous widely ranged diverse functions within the cells, tissues and the organ systems of Homo sapiens.Taurine (2-aminoethanesulfonic acid, equally referred to as Tauric acid) is a non-proteinogenic sulfonic amino acid. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Besides its abundance in the bovine and human bile, it has equally been discovered to be significantly present in the plasma, erythrocytes Leukocytes and platelets,Retina,Kidney,Liver, fish,poutry,eggs(albumen&yolk) dairy products, and energy drinks etc. It equally exists in several animal tissues, such as in the heart muscle, the brain and the skeletal muscles etc. I have closely followed, examined, reviewed and analysed the basis and essence of the scientific narratives in the index scientific research article on this theme, given through the linked source to the Questions on this theme. Following its discovery, early testing and development, it is certain that Taurine have successfully passed through its late anti-aging candidate ‘Taurine’ would have successfully passed through these itemised steps and phases. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES The discovery and developmental steps of Taurine(Step- I). In the discovery of Taurine, it is probable, that the elucidation of the roles of free radical and reactive oxygen species in the initiation, propagation and acceleration of the aging process and its comorbidities, in addition to the anaticipated,known and unprecedented toxicity concerns of the mentioned senolytics, drove developers and scientists to search for other more equitable less toxic natural anti-aging compounds. Although, this step could have involved the evidential and serendipitous testing of several chemical compounds objectively for its positive impact on delaying aging, however, in this context, Taurine was one of the few most promising agent overall. Having identified Taurine as a potentially, positive and probably worthy antiaging candidate, as a developmental step for Taurine, the developers, investigators and scientists employing what is already known about the biological and chemical behaviour of Taurine,then undertook series of “mock” prepilot laboratory tests ,in order to acquire primary data on Taurine’s absorption, distribution, metabolism, excretion and elimination, in addition to the potential benefits and mechanisms of action of Taurine. Also, during the developmental steps of Taurine, the scientific developers, scientists and investigators aimed to elucidate, the proximate optimal and utmost dosage ranges and preferred routes for its administration. Further considerations at the developmental steps of Taurine included, its side effects, adverse events, toxicity profiles, its contexual age, constitutional, familial, genetic, ethnographic and racial idiosyncrasies. Additionally, Taurines comparative effectiveness and interactions with other pharmaceutical agents were examined by the relevant scientific stakeholders.etc. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Preclinical Research (Step II) Conventionally, it is given that presumably, preclinical studies may not need to be all that very extensive and huge. It was always aimed and envisaged by the scientific preclinical research team for Taurine’s development, that a major milestone in their research will be the proffer of a meaningful and scientific report on the dosage ranges and toxicity profiles of Taurine as a putative potential antiaging agent. Although Taurine’s pharmacotherapy may target the elderly aged population, however concerns of earlier onset idiopathic senescence besides the progerias, implies that an advanced -stage preclinical experimental animal system models testing will be desired for Taurine in order to evaluate its impact with the induction of carcinogenicity, in addition to its behaviour with the reproductive systems and embryogenesis etc. Admittedly, previously, there was always an iterative emphasis on the need for a rigorous observance of the specified ethical considerations on the use of animals as preclinical experimental test system models. Fairly recently however, the preclinical research step of drug development has become a very intriguing and dynamic step. There is now a concerted effort by several life sciences conservation, preservation and protection organisations that animals should not be used at all, if there are comparable alternatives or options.(EARA 2023) It appears that, increasingly several animal research organisations are using novel direct organ targeted drug delivery devices or are altogether moving away from direct in-vivo animal based test system models, but instead are using in-vitro models of stem cell derived cell, tissues and organ system models etc based targeted invitro tests with comparable and equitable results. .(EARA, 2023) The policy of the 3Rs (Replace, Reduce, Refine) was enunciated in 1959 and grounds down the preferable ideal standards for research with animals. The 3Rs are pivotal components of the regular principles guiding the activities of the international biomedical sciences sector and are an integral part of both regional and international statutory regulations which modulates the employ of animals in technical scientific research procedures. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Preclinical Research (Step II) While some scientific research procedures implies the employ of experimental animal test system, others may not necessarily. While the application of preclinical experimental animal test system models may be determined and used universally in several disciplines of scientific biomedical research, the National Institute of Health (NIH) encourages researchers to strongly consider the use of other alternative and complementary strategies in guaranteeing stringent, robust and consistent comparable research data as much as would be achievable. To date, all pharmaceutical and biologicals drug development laboratories have been requested to apply the regulatory Good Laboratory Practice (GLP) standards for preclinical laboratory studies, as described in the food and medical product developments guiding documents by the Food and Drug Administration (FDA) and Taurine development is not exempted from these. The Center for Drug Evaluation and Research (CDER) is the departmental unit in FDA that guarantees that only safe and effective food and pharmaceutical agents are available to the public to improve the health of the people in North America and beyond. In these regulatory guidelines,FDA&CDER has set the minimum standards that should be attained by the drug development facility for Taurine ,with regards to, but not confined to the: research facilities site, equipment, research project execution and management, scientific research experts and human resource edication,experience and qualifications, documentation of research procedural protocols and standard operating procedures. Following a rigorous and standardized preclinical testing, the drug developing scientific stakeholders’ researchers for Taurine will proffer an account of their investigations and evaluate their results, and through diligently expert moderated scientific drug development research meetings determine on the implications, rationale, feasibility and logistics of testing Taurine on selected and predefined groups of Homo sapiens. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES The Prospective Clinical Research For Taurine Drug Development(Step-III). As given above in this contexual index article, although certain fundamental questions on Taurine’s safety and toxicity profiles could have been addressed at the preclinical research step of its development, however the overall behaviour of Taurine as given in this scientific index article’s experimental preclinical mice rodent system model, could not be directly extrapolatable to Taurines interactions, toxicological profile and characteristics in vivo in Homo sapiens. To attend to these pertinent pivotal clinical research questions, further rigorous drug developmental investigational clinical trials and studies in appositely selected groups of Homo sapiens must be undertaken for Taurine. During the conceptualization and planning phases of the clinical research phase, the scientific drug development stakeholders for Taurine would have thoughtfully mapped out, their milestones and what they aim to achieve at any given phase of the clinical research step of Taurines investigational drug development. In order to proceed seamlessly with Taurines clinical research trials, this conceptualization, planning, other analytical and methodological issues for Taurine drug development have to be completed and moved out of the way at the first instance. Thereafter, the investigational novel pharmaceutical agent process for Taurine will have to be successfully completed, before the clinical research phase of Taurine’s drug development will commence in earnest. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES The Investigational Novel Pharmaceutical Agent Process for Taurine. The Taurine’s pharmaceutical agent developers, scientists, investigators and sponsors, will have to submit an investigational novel pharmaceutical agent application to the Food and Drug Administration (FDA) before the commencement of the clinical research study for Taurine’s development. In the investigational novel pharmaceutical agent process for Taurine application, its developers will be expected to attach the principal investigators curriculum vitae,the Taurines drug development preclinical experimental animal test systems based studies data and toxicity profiles and data from any prior human research, if any. Additionally, the Taurine investigators will be expected to include data on Taurine’s anticipated manufacturing information and the clinical research study protocols, in addition to the study plans for Taurines development data from any prior research on Homo sapiens etc. It is expedient to indicate that the scientific drug development team for the Taurine will be free to contact FDA for clarification and acquisition of guidance information brochure at any stage in the Taurine’s pre-Novel pharmaceutics agent development process, or in order to resolve and demystify ambiguities and enigmas that may improve the outcome of Taurine’s drug developmental research. Also, Taurines drug developmental stakeholders could equally contact FDA/CDER to verify the progress and status of their Taurines pre-Novel pharmaceutics agent development process application. It is equally pertinent for the Taurines drug developmental stakeholders scientific team, that even though FDA/CDER could espouse a wide ranged guidance and support on several scientific, ethical and regulatory aspects of Taurines drug development, however, the drug developmental team for Taurine are not mandated to accept or implement the FDA’s proposals and recommendations, if they wish otherwise, except it is a regulatory directive. It will be heartening for Taurines drug developers to realise that provided that their clinical trials for Taurine were diligently, meticulously and scientifically rigorously conceptualized and designed, depicts what the Taurine drug developers have researched so far of their product, and protects the study subjects, while being consistent and in conformity with the central statutory regulatory norms and standards, FDA/CDER could permit some reasonable flexibility in Taurines drug development clinical trials design structures. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES An extrapolated Investigational Novel Therapeutic Agent Review Process For Taurine. Following the completion of its preclinical step, for Taurine to be accepted in the clinical research step of its development, it must undergo a rigorous assessment, evaluation and review by the Food and Drug Administration and CDER investigational novel pharmacotherapeutic agent review committee. The prospective Taurine review committee, although will function as a unified committee, is endowed with the extensive and widely ranged capability and capacity to cope with the rigorous review the Taurine’s drug developmental processes. As a novel pharmacotherapeutic agent, Taurine and its scientific developmental team will be assessed, evaluated and reviewed for its preclinical invitro and experimental animal test system models based invivo studies by the FDAs scientific pharmacologist. The analysis, evaluations and reviews of Taurines chemical components and the processes of how Taurine was compounded and synthesised, in addition to Taurine’s chemical quality, its stability, Taurines chemical composition consistency, its continuity,and the possibility of the presence of impurities if any will be achieved by the FDAs responsible scientific pharmaceutical chemist. Similarly, Taurine’s developmental drug’s absorption, distribution, metabolism, elimination and excretion processes, in addition to its profile will be examined and reviewed by the FDAs responsible scientific Pharmacokineticist. The FDAs pharmacokineticist will equally be responsible for undertaking the interpretation of Taurine’s blood-level data at different time intervals from clinical trials, as a way to evaluate and determine the optimal dosage ranges, in addition to the administration intervals and schedules for Taurine. The assessment, evaluation, analysis, profiling and reviews of the submitted preclinical laboratory data on Taurine, for its methodological issues and scientific integrity will be in the remits of the FDAs responsible scientist, scientific analyst and methodologist. The interpretation of clinical trial designs and data management procedures will be undertaken by the FDAs statistician, who will equally need to collaborate collegially with the FDA’s scientific medical officer to appraise and review the Taurine’s drug development protocols and its safety and efficacy data. Other important considerations for the role of the investigational Taurine, novel pharmaceutics FDA/CDER review committee will be reviews of all clinical study information and data before, during, and after the trial is complete which is usually undertaken in co-ordination with other relevant stakeholders by the FDA’s scientific medical officer. The FDAs Quality Assurance auditor and Monitor in coordination with the Taurines other scientific stakeholders will examine, review and appraise all the Taurine’s drug developmental investigator’s brochures, dossiers, protocols, standard operating procedures, preclinical experimental animal test system models, data archiving, computerised systems, Taurine extractions, formulations and synthesis research reports, in addition to the various facets and steps outlined for their quality assurance standards in conformity with the ISOs for Good Clinical,laboratory,manufacturing,statistical and computerised practices etc. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES An extrapolated Investigational Novel Therapeutic Agent Review Process For Taurine. The FDAs project manager coordinates the overall committee activities throughout the review process, and will be the first point of access to the FDA for the Taurines drug development research study sponsor and policy formulators. Prospectively, the FDA’s review team for Taurine will allow about a month for the assessment, review and appraisal of the substantive Taurine’s investigational novel pharmaceutical agent review submission. The FDA conventionally could respond to this submission for Taurine as an authorisation and approval to commence clinical trials with Taurine as a potential candidate antiaging agent. Equally, on the otherhand, FDA may place a moratorium and mandate a clinical hold to postpone all the clinical research trials on Taurine or for the investigations on Taurines drug development to be terminated totally. In other instances,FDA could strike a clinical moratorium on Taurines further development for specific reasons, such as but not confined to the fact that the Taurine’s drug developmental research investigators were deemed to be unqualified for the conceptualization,planning,initiation,implementation,execution,evaluation and conclusion of Taurines drug developmental research processes and projects. Also the FDA may deem it appropriate to suspend the Taurines drug developmental research processes, if the Taurines testing study subjects are anticipated to be or actually exposed to unjustifiable, consequential and unquantifiable risks, whilst partaking in the study. Other untoward considerations that would warrant FDA to place a moratorium on Taurines drug developmental processes would include if the descriptions and methodology for the voluntary partaking in the research by the Taurines study subjects participants are ambiguous, inconsistent and reveals some element of duplicity. Also, naturally, FDA would not be expected to welcome an application that is compromised and limited in the provision of the statement on T aurine’s drug development research trials risks and the measures that were instituted to mitigate these risks etc. Since historically, a clinical moratorium is relatively uncommon, FDA may likely proffer annotated remarks aimed at enhancing the overall standards of Taurines drug developmental clinical trial. Almost always, if FDA is convinced that the clinical trial for Taurines drug development will attain given statutory standards, the Taurines drug development applicants will be approved to progress and commence their proposed clinical research study. Provided the Taurine scientific drug development team accents that they are subject to rigorous ethical, scientific and professional standards, such as but not confined to being responsible for informing the FDA review team about new protocols, as well as serious side effects, adverse events or toxicity profiles observed during the Taurine drug development research trials. In this way, the FDA review team would be reassured that they could assess, evaluate, follow up and monitor the Taurines drug development trials diligently and meticulously for any features of imminent challenges and difficulties. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Designing Clinical Trials For Taurine as a candidate antiaging agent. The drug developers, scientists and other scientific stakeholders for Taurine will need to address pertinent scientific investigational ambiguities pertaining to Taurine as a prospective putative medicinal agent. The scientific investigators, manufacturers and sponsors for Taurine drug development will have to abide by standardized analytical algorithm, standard operating procedures and protocols etc. Prior to the commencement of the clinical trial research for Taurine, the Taurine drug development scientific team would have to formulate a theoretical framework following a diligent and rigorous examination of the existing knowledge base for Taurine in order to achieve a conceptual framework, and their aims, essence and purpose for the task ahead of Taurine drug development clinical research step. In this way, they will be in a vantage position to decide on and accomplish the challenging task of the determination of the study population, the need and feasibility for a control arm and randomization, in addition to other ways of discouraging bias, the identification and inclusion of the Taurine drug development clinical trial and research studies. Other seminal points that will need to be discussed and concluded at this step of Taurines drug clinical research are the exclusion criteria for this study, the appropriate length of time required, and the apposite routes of administration in addition to the dosage ranges for Taurine in Homo sapiens. The assessments, evaluations,monitoring, data collection,review,analysis, and management ,quality assurance audit, in addition to its dissemination and publications , the methodologies and timings for these scientific activities, would be other important considerations at this Taurine’s drug development clinical research step . On the basis of the recognized prevailing convention, the drug development research clinical trials for Taurine will need to conform to the traditional arithmetical progressive pattern of the initial limited sampled phase one (1) studies through the averagely sampled phase two (2) studies to the extensively sampled terminal phases three (3) and four(4) studies . In the phase one(1), clinical research studies for Taurine, given that ageing is a fairly common obligatory phenomena ,this will involve the enrollment of about thirty(30) to ninety(90) healthy consenting adult good-willed subjects ,who as bonafide research subjects will need to be diligently, meticulously and rigorously studied over several months following the administration of Taurine through the appropriate authorised route ,within the previously specified dosage ranges. The whole essence and objective of subjecting Taurine to the phase one (1) clinical research study is to ascertain and elucidate its precise dosage ranges, frequency of administration and its toxicity pattern and profile, in addition to Taurine’s fundamental pharmacokinetics, tolerability, in order to address and inform any safety issue concerns in Homo sapiens. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Designing Clinical Trials For Taurine as a candidate antiaging agent. On the basis of the existing comparable data ,it is expected that Taurine as a candidate anti-senescence pharmacotherapeutic agent, having come this far in its development would have about a three(3) in five(5) to four(4) in five(5) chances of proceeding to the next phase of its developmental clinical research study. In the phase two(2), clinical research studies for Taurine, given that ageing is a fairly common obligatory phenomena ,it would not be overambitious to recruit about two hundred(200) to exceptionally nine hundred(900) consenting good-willed elderly subjects ,who as bonafide research subjects will need to be diligently, meticulously and rigorously studied over several months to up to twenty four months or so ,following the administration of Taurine through the appropriate and authorised route ,within the previously specified dosage ranges. The whole essence and objective of subjecting Taurine to the phase two (2) clinical research study is to ascertain and elucidate its acclaimed efficacy as an anti-aging agent and recognize and document its possible and probable side effects, in addition to appreciating and comprehending its dose-response relationship in order to accurately inform on these issues concerns in Homo sapiens. On the basis of the existing data from other cogent pharmacotherapeutic agents development fact sheet, it is expected that Taurine as a candidate anti-senescence pharmacotherapeutic agent, given the rigour of the review and the deterministic intricacies of this ‘rate limiting step’, even though Taurine could have come this far in its development would have about one (1) in three (3) chances of progressing to the next phase of its developmental clinical research study. In the phase three(3), clinical research studies for Taurine, since this phase is more deterministic, in other to achieve the desired statistical power, the scientific developers for Taurine would be aiming to recruit about three hundred and fifty(350) and exceptionally up to about two thousand nine hundred(2900) consenting good-willed elderly subjects ,who as bonafide research subjects will need to be diligently, meticulously and rigorously studied over several months from thirteen (13 to 48mons) up to forty eight months or so ,following the administration of Taurine through the appropriate and authorised route ,with in the previously specified dosage ranges. The whole essence and objective of undertaking the phase three (3) clinical research study is to ascertain and elucidate Taurine’s acclaimed efficacy and undertake monitoring for its recognized and unanticipated new-onset adverse effects while being used as an antiaging agent in a controlled clinico-pathological and epidemiological settings ,in order to accurately inform on these issue concerns in Homo sapiens. On the basis of the existing data from other cogent pharmacotherapeutic agents development fact sheet, it is expected that Taurine as a candidate anti-senescence pharmacotherapeutic agent, given the rigour of the review and the deterministic intricacies of this ‘rate limiting step’, even though Taurine could have come this far in its development would have about one (1) in four (4) to one (1) in three (3) chances of progressing to the next phase of its developmental clinical research study. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Designing Clinical Trials For Taurine as a candidate antiaging agent. Although, there could be some overlap between the phase three (3) and phase four (4) Clinical Research Studies for Taurine drug development,however,the phase four(4) Taurines drug development will be terminal and more deterministic, technically speaking, as it is usually ,more or less, it will be a post-marketing regulatory phenomenon for Taurine and, in order to achieve the desired statistical power, the scientific developers for Taurine would be aiming to recruit thousands of consenting good-willed elderly subjects consumers and end users of Taurine, who as bonafide research subjects will need to be diligently, meticulously and rigorously studied over several years and exceptionally over decades or so ,following the administration of Taurine through the appropriate and authorised route ,within the previously specified dosage ranges. The whole essence and objective of undertaking the phase four (4) clinical research studies is to further ascertain, confirm and reaffirm Taurine’s acclaimed efficacy and safety profile, while being used as an antiaging agent in a controlled clinico-pathological and epidemiological settings, in order to accurately inform on these issues concerns in Homo sapiens. Just like is the case in the preclinical phase, Taurines drug development team could ask for FDAs guidance document, support and advice, especially after the Phase 2 Taurine’s clinical research trial, to acquire guidance on the best way to achieve the design of huge Phase 3 studies clinical research trial for Taurine. This phased clinical trial for Taurines drug development is sustained until the time for these step have elapsed and the Taurine drug development stakeholders decides to conclude the clinical trials and files a marketing application. As soon as the Taurines clinical research trials is completed, the clinical investigators are obliged to proffer to FDA, a technical scientific research reports on its Taurines drug development processes. It is conventional that before filing in a marketing application for Taurine, its scientific developing team should proffer a dataset that has met the FDAs specified data, and considered adequate, by FDA for an obligatory and common phenomenon as aging normally this implies that Taurines development and marketing proposers would have presented data from at least two huge, randomized controlled clinical trials of Taurine as an antiaging agent. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES FDA Pharmacotherapeutic Agent Review For Taurine-Step IV. This step would be proceeded to, if the Taurine’s drug developers could demonstrate with a very robust evidential data proof, from its preliminary tests and preclinical experimental invitro and invivo animal test system models, in addition to multiphased clinical research trials, that Taurine as a candidate pharmacotherapeutic agent is safe and effective as an antiaging agent, they could file in an application to market Taurine as a licensed antiaging pharmacotherapeutic agent. Thereafter, it is then in the remits and purview of the FDA review committee to diligently,meticulously and rigorously assess, appraise and review the proffered Taurines data in its entirety and then offer a recommendation on whether Taurine would be approved for use as an antiaging agent or not. Well before the discovery of Taurine as a promising antiaging agent, for a long time, FDA has aimed to discourage any undue redtapism, bureaucracy or bottlenecks in its novel drug approval processes, without compromising the quality of its review, and this will be FDA’s approach with Taurine. Hopefully, if all goes well, when all is very well set, the FDA’s Approval process for Taurine could be rapidly achieved as well. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Novel Pharmaceutical Agent Application For Taurine. In its novel pharmaceutical agent application for Taurine, the scientific developing team for Taurine will aim to proffer a structured narrative account of the salient and relevant features of Taurine before its discovery, during its discovery and all the preclinical, clinical and the other aspects of its developmental periods. In essence, the Taurines scientific drug development team would be expected to proffer a scientific communication on all the pertinent data on Taurine from its antiaging agent conceptualization, discovery, development and through its preclinical data to the conclusion of its clinical research trial data, in the investigational novel pharmaceutical agent application for Taurine before its submission to the FDA. It is anticipated that Taurine’s drug scientific development team will endevour to incorporate reports on all studies, data, and moderated analysis and mock reviews etc. Also, it is pertinent that in addition to clinical results, Taurine drug scientific development team will aim to proffer information on the contexual institutional review board compliance statement, in addition to information for any data from studies on Taurine conducted outside North America by their team. It is equally anticipated that the Taurines drug development team, will include in their application for Taurine’s registration and approval, its anticipated labeling strategy, its safety updates, possible misuse and patent information etc. The whole aim ,essence and objective of this concise and precise encyclopaedic monograph on Taurine is to prove that Taurine is contextually safe and effective for its intended use as an antiaging agent in the intended studied population. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES FDA’s Anticipated Review Process For Taurine. FDA would only be able to review the novel pharmaceutical agent application for Taurine, when the FDAs review committee has determined that the application is complete in its entirety. The FDA review committee will allow about twenty four (24w) weeks to forty(40w)weeks in order to determine, if the employ of Taurine as an antiaging agent will be authorised and approved or not. On the basis of the prevailing convention, it is envisaged that the FDAs review of the clinical research step and phases of Taurine development will be analogous to the processes in its preclinical studies reviews, which warrants that every personnel of the FDA review team undertakes a comprehensive assessment, examination, appraisal and review of the components within the purview of their expertise, such as the FDAs quality assurance auditor and monitor reviews the various chapters of the novel pharmaceutical agent application for Taurine, for its conformity with the ISO’s,and the good clinical and laboratory standards etc. With all the relevant scientific specialties inherent in the FDAs review committees, being complemented by a supervisory review, FDA auditors, inspectors and monitors could convey to any Taurine development study sites in The North America and beyond to conduct a routine audit, inspection or monitoring. Like the case in other similar studies, the whole aim, objective and relevance of the FDA inspectorate committee for Taurine research study, is to search for evidence of data incongruity falsification, duplicity, or hoarding. Having achieved the preliminary review processes, the FDA project manager assembles all its committee member thematic reviews, the report from its auditors, monitors and inspectorates, as a unified recorded working document as an action package of FDA review for Taurines development as an antiaging agent. It is conventional that following an FDA review for Taurine,the review committee will proffer their recommendation, and a designated responsible scientific FDA governing board director will produce an authorizing statement on whether Taurine should be approved as an antiaging agent or not. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES FDA Approval and Labeling For Taurine . Following all these preliminary approval processes, if FDA determines that as a candidate pharmacotherapeutic antiaging agent, that Taurine has been demonstrated be effective and safe for this purpose, FDA will now be in a position to co-ordinate with the Taurines developing applicant team to finetune and modify Taurines prescribing information as an anti-aging agent, in a process that will technically be described as the labeling of Taurine. The Labeling of Taurine will concisely, precisely, correctly, thematically and succinctly characterize and technically present the scientific justification for the approval and authorisation of Taurine as an antiaging agent and how the most benefit will be derived from its use in this specific context. However, it may not be unusual for the Taurine drug development applicants to be asked by FDA to address certain outstanding pertinent matters, before Taurine could be approved and authorised to be marketed as an anti-aging agent. Occasionally, FDA may request that the Taurine development stakeholders attend to some query on some ambiguous and complex research processes or data. In other instances, FDA may recommend that further research data and studies in addendum on Taurine, as an anti-aging agent would be imperative in order to be able to determine if the approval of Taurine in this context would be achievable. Having come this far in the Taurines as an anti-aging agents developmental processes, the responsible development scientific stakeholders could still decide if they will wish to sustain their efforts on the Taurines developmental researches or not. Of course, the FDA in their regulatory guidance brochure and document made it explicit, that at this stage of Taurines Drug development, that the FDAs stance on the approval of Taurine as an anti-aging agent could be appealed, and the mechanisms for the official appeal processes are available. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Exceptionally, there may be a need for FDA Advisory Committees on Taurine to be set up. Normally, ideally, it is envisaged that the novel pharmaceutic agent application for Taurine will contain an adequate data to assist FDA in the assessment and appraisal of Taurines effectiveness and safety as an anti-aging agent. Seldomly, exceptionally however, circumstances and issues could emanate that may evoke the need for additional determinations and evaluations to achieve scientifically cogent decisive conclusion on Taurine in its antiaging role. When these circumstances and instances ensues, FDA could be obliged to convene a technical scientific conference of its relevant contexual advisory committees to get an authoritative, expert, objective and unbiased opinion, in addition to allowing the concerned community, citizens of science and non-specialist citizens ‘jury’ to contribute and share their perspectives on the way forward to conclude Taurines authorisation as an anti-aging one more. It is conventional that these advisory committees will co-opt aging elderly patient(s) representative(s) that will proffer contributions from the aging patients viewpoint. In essence, for Taurine to be approved as a pharmaceutical agent, it must successfully pass through these itemised FDA Drug Development Processes, Discovery and Development(Step I);Preclinical Research(Step II);Clinical Research(Multiphased Step III);FDA Drug Review(Step IV). ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES FDA Post-Market Drug Safety Monitoring For Taurine(Step V) Following its approval for marketing, FDA’s post-market drug safety monitoring for Taurine would be imperative, because although the rigorous developmental clinical trials for Taurine addresses several seminal issues on Taurine’s efficacy and safety, it is expected that the Taurine’s drug development stakeholders could accept the limitations and restrictiveness of the Taurine’s literature data so far up to its approval and marketing authorisation processes. Although the steps in the process of Taurines development, could have been very diligent, meticulous and stringent, it will be expected that as is the case with other preceding novel candidate pharmacotherapeutics, some gaps will not be very unusual. For a long time, it has been scientifically appreciated that the real profile of an approved pharmaceutical agent’s safety emanates over several days, weeks, months, years, decades and occasionally even centuries, following its availability in the pharmaceutical market and use, even within its usual dosage range and patient group, and Taurine may not be exempted from this unanticipated untoward chemical, biological or pharmaceutical behaviour. Therefore, it will be within the purview of FDA to assess, analyse, appraise and review the notification trends on the challenges and difficulties with Taurine as an approved antiaging pharmaceutical in the market and update the alerts and warnings to its dosage or usage literature data. In addition, FDA is obliged to ensure the provision of data for the implementation of controls and preventions for untoward issues. Other important considerations for the FDA’s postmarketing regulation of Taurine as an antiaging agent will include, but not confined to its modulatory role novel Taurine’s supplemental applications, its frequent evaluation and monitoring of Taurines attributes and behaviour as an investigational pharmaceutical agent, which is marketed as an antiaging agent, in addition to Taurine’s manufacturer inspections, Taurines advertising, Taurines analogous generic drugs, reporting problems and Taurines overall active surveillance. (Qato DM, Alexander GC 2011). ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Supplemental Applications For Taurine. The Taurine scientific development stakeholders will already be aware that in future, if they wish to proffer a complementary or supplemental application on taurine as an antiaging agent,which will warrant considerable modifications to their index investigational novel pharmaceutical agent application, such as any modifications to Taurines compounding, labeling, or dosage frequency, ranges, intervals and potency, this new process must be authorised by FDA before they could be implemented.(CDER2021) ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Further FDAs Investigational Novel Pharmaceutical Agent considerations for Taurine as a Marketed Drug. Additionally, the Taurines development scientific stakeholders will need to be brought closer to the fact that, if the already FDA approved antiaging agent, Taurine’s sponsors want to further develop Taurine for a new use, modify its antiaging dosage, strength, new form, or different form (such as an injectable or oral liquid, as opposed to tablet form), or if they want to conduct other clinical research or a post-market safety study, they would need to do so under an FDAs recommended, approved and authorised investigational novel pharmaceutical agent protocol. (CDER ,2021), ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Taurines Manufacturer Inspections. It is the norm that FDA/CDER experts will undertake situational analysis, impromptu, circumstantial, perfunctory and regular interval inspections of Taurine drug manufacturing laboratories across North America, and in other regions overseas if there are authorised pharmaceutical laboratories which produce Taurine internationally. The whole aim of these FDA/CDER inspections is to ensure that the Taurine-antiaging agent development stakeholders will be abiding to the good manufacturer practices (GMPs), GLPs, GCPs, GXPs)etc. FDA/CDER has an inherent mandate to place a moratorium or close down any of the Taurines drug development infrastructure if the prescribed basic good practices standards are not being adhered to. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES The prospective Regulatory Aspects of Taurines Drug Advertisements and Promotional marketing Labeling. It will be within the remits of FDA/CDER to modulate the Taurines advertisements and marketing labeling. On the basis of the conventional and prevailing statutory practices, the Taurines development stakeholders will not be authorised to promote or advertise the unapproved and unlicensed applications and employ of Taurine, besides its use as an antiaging agent. It will be the responsibility of the Taurine drug development stakeholders to ensure that there are no misrepresentations, duplicity and fallacy in all their promotional marketing activities and product efficacy assertions for Taurine as an antiaging agent. The Taurine development stakeholders must ensure that they present factual and bonafide communication in the literature about Taurines efficacy, effectiveness, side effects, dosage ranges and pharmacopeial details. Also, it is pertinent for the Taurines development stakeholders to ensure that their advertisements and promotional labelings for Taurine are distributed through the appropriate communications media, (i.e mainstream health and medical journals, periodicals, newspapers, magazines, television, radio and the Internet etc, for Taurines advertisements. Similarly, it is within the remits of the Taurines development stakeholder’s pharmaceutical ventures to ensure that their promotional labeling materials are channeled through the grey medical literature to the clinicians or end-users in conjunction with Taurines antiaging prescribing data literature. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Reporting Problems with Taurine. FDA /CDER has been endowed and equipped with numerous mechanisms that will facilitate the processes by which Taurine end users, geriatricians, gerontologists, and allied clinical and health workers, in addition to Taurine manufacturers when they wish to make representations to the FDA/CDER and its associated agencies on the challenges, dififculties and their untoward concerns with the use of Taurine as an approved antiaging pharmaceutical. Active Surveillance mechanisms For Taurine-an antiaging agent With the support and facilitation of several innovations, FDA/CDER already has and has been inventing and advancing several mechanisms to very rapidly detect imminent safety issues on all approved pharmaceutical and as a potentially promising “approved” antiaging agent, Taurine will not be exempted from this check. . Some of these mechanisms will employ huge existing electronic medical and health databases—such as electronic medical science and health records mechanisms, health maintenance organisations (HMOs) financial and health insurance claims databases, and aging registries—to monitor, track and records the safety of Taurine as an approved antiaging pharmacotherapeutic agent instantaneously. These Taurine safety monitoring innovations will complement FDA's ongoing post ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES The FDAs recommendation For The utmost management of the probable futuristic prospective Taurines prototype Generic Pharmaceutical Analogues(stereotypes). As a novel bonafide antiaging agent, Taurine will be patented and protected for the index Taurine prototype producers, as soon as Taurine has been approved and authorised for marketing by the FDA. This means that only the sponsor has the right to market the drug exclusively, until the patent period time elapses or the Taurine inventing and manufacturing index primary patent prototype company decides to, Franchise one of its extramural apposite drug manufacturing member organisation laboratory to partly partake in this Taurine manufacturing processes. Once the Taurines patent expires, other drug manufacturers could now develop and manufacture Taurine, in this given context, this form of Taurine from a secondary manufacturing source will be technically referred to as the generic form of Taurine. Naturally, technically speaking, it is already given and will be reiterated that these given generic forms of Taurine will be equivalent and analogous to the prototype index branded Taurine in every way and must have the same: safety, efficacy and effectiveness characteristics and profile, potency, dosage ranges, frequency and intervals, in addition, it must be used solely as an antiaging agent in this context. Given that these prospective generic colorates of Taurine will be collatable to the index Taurine with ongoing marketability, Taurines generic drug manufacturers will not necessarily be obliged to undertake clinical trials to prove that their newly manufactured Taurine pharmaceutical agent is safe, efficacious and effective. However, they will be expected and obliged to undertake Taurine bio-equivalence research investigations to complement and support their summarized, concise and precise investigational novel generic Taurine equivalent pharmaceutical agent application. Like is the case with the index premier prototype Taurine, all the bioequivalence research investigations, its post marketing and pharmacovigilance phases for the novel generic Taurine equivalent pharmaceutical agent must be conducted under GLP,GCP, GMP, GPP, GSP, GCP etc. So far, the limited human clinical trials on Taurine lacks the statistical power ,mature data and wider geographical range to proffer a robust data to support the evidence for the licensed recommendation of Taurine as an antiaging agent in the wider clinical and epidemiological societal context. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES The Positive Psychological Impacts of Anti-Aging Pharmacotherapies. The “physiological process of aging” has been a peculiar fight and struggle for Homo sapiens, since the renaissance and modernization of life, with this specie being the most encephalized and evolved and therefore persistent in their struggle to win this battle against senescence, by being even very willing to pay a huge price and travel across several regions, oceans, mountains and forests to achieve a worthy outcome of a rejuvenated appearance and energy. Comparatively, the link between senescence and healthy psychology, confidence, self-esteem is inherent in Homo sapiens, which is what partly or wholely sustains the enterprise of prophylactic and therapeutic naturally, pharmcognostically and synthetically derived senolytics and biologicals such as Taurine. Having followed, examined reviewed and analyzed several articles on how the use of senolytic agents employed for cosmesis positively influences the beneficiaries’ psychology with regards to cosmetic and sense of wellbeing conceitedness and self-esteem etc, I could infer that the use of these anti-aging agents is aimed to reverse the negative physical, health, social, economic and psychological alterations of “unhealthy aging” into a “healthy aging process”. These multifaceted psychological, social, economic, physical, Health and physiological negative impact of these untoward aging processes are frequently aggravated by the family,work,institutional,and community contexual demands to measure up to the cosmetic trends and fashionable codes of the institution, the contemporary society and otherwise. The late middle aged and the about to retire age groups have been known to patronize the use of the anti-aging interventions most with the overall objective of aiming to sustain a youthful and good-looking profile. Given my keen interest and research on this theme, I have deciphered that a youthful and graceful appearance, enhances the confidence, sense of physical, social, economic, mental and psychological health, esteem and overall well-being of this contexual group. It has been known that these positive psychological attributes are pivotal for the coping mechanisms for, imminent, new onset and ongoing senescence. This factual stance, drives home the argument for the encouragement of an enhanced holistic and unified strategy for the utmost management and co-ordination of the augmentation of the psychological well-being of the elderly as a distinct physiological age group, which implies the proposal and institution of apposite multimodal anti-aging diagnostic,prognostic,therapeutic,prophylactic and integrative interventions. (Onyekwelu,E ,2020), ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Conclusive Remarks and Recommendations It is worthwhile to caution and recommend that the use of Taurine( a non-proteinogenic aminosulfonic acid) in the fortification of the delicacies and beverages of Homo sapiens works optimally with the adjunct of living a healthy, wholesome and hygienic lifestyle such as the eschewing of obesity, excessive alcohol and tobacco consumption, in addition to the avoidance of undue psychogenic trauma and the prevention of carninomas, infections and infestations, the choice of the mediterranean type of diet and the encouragement of consistent graded exercise such as walking etc. In essence, more long-term prospective cohort studies and randomised controlled trials on a variety of age groups with longer follow-up periods, larger sample sizes, and higher dosages are needed before an unambiguous association with the pros and cons of Taurine fortification as a credible candidate free radical mopping up antioxidant biologic pharmacotherapy in gerontology could be widely recognized, welcomed and accepted. Thus it is likely that with the employ of very diligently, meticulously and rigorously designed gerontological researches, probably Taurine as a candidate novel pharmacological agent will hold a lot of promise in the ongoing and future geriatric prophylactic and therapeutic armamentarium. Familial genetic constitution, are other deterministic factors for longevity. I have followed, examined and analyzed several mentioned articles on this theme, which suggest that although, there are some credible evidential scientific data which infers that utmost nutritional or pharmacotherapeutic interventions may delay ageing and advance longevity in the abbreviated life spanned organismal ,rodent and mammalian experimental test system models. On the basis of the given articles above, although, there are also some convincing scientific data that these results could be extrapolated for other primate species and Homo sapiens with much more lengthy ageing and longevity profiles, however the prolonged study periods (in decades) warranted by the appropriate aging and survival profile research in Homo sapiens and the primate species has been elusive although the emerging data on this theme appears to be The near explosion of gerontological investigational studies over the last couple of years would probably establish or refute the effectiveness of nutritional and pharmaceutical prophylactic and therapeutic interventions to positively modify and delay the senescence pathways. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Conclusive Remarks and Recommendations Principal challenges and shortcomings to the attainment of meaningful and scientific conclusions in Homo sapiens are the correlates of improved longevity in this species which could ontologically be up to ten decades or more, in addition to the heterogeneity of the existing research project surveys. With regards to the nutritional interventions, the agreed limits on dietary restrictions, commencement periods, and the exact duration of the interventions, in addition to dietary compositions would differ significantly between and amongst investigational surveys, whereas pertaining to pharmaceutical interventions, the commencement period aside, other major concerns would include, but not confined to the length of the therapeutic interventions sustained and the dosage ranges and frequency etc. Also the extensive and huge miscellaneous subsets of interventional study protocols presents an ambiguous and cumbersome embargo that circumvents the achievement of meaningful conclusive reports, especially with regards to which research pathway is more evidential ,in addition to blurring the decisions on when research projects should commence ,with the overall aim of augmenting efficiency. However, despite the inconclusive reports from the impact of nutritional therapeutic and prophylactic interventions on healthy ageing and longevity in humans and monkeys, the enhancement of the overall health conditions in the primates and Homo sapiens appears to be convincing, inferring that these approaches on the average, augments the overall holistic aspects of the health of Homo sapiens and the primates, which invariably will impact positively on their overall a healthy aging state and longevity. Moreover, it has been demonstrated that the enrollment and participation into antiaging clinical trials have remarkably bolstered and enhanced the psychology, self-esteem, sense of overall wellbeing and confidence of the senile participants. Therefore, it is imperative that following an appropriate selection and matching that ongoing studies on these themes would need more harmonization, homogenization, standardisations and coordinations. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Conclusive Remarks and Recommendations Enhanced compaction and consortia based coordination of studies which will facilitate the management of more elaborate longitudinal studies and cross sectional surveys in addition with a rigorous and rigorous biological system dissection, in the broader scientific context will be worthwhile in order to postpone, circumvent and counteract senility-related morbidities and mortalities. It is heartening that there have been an attempt with some innovations aiming to examine, collate and collectively nest together study designs, approaches, conceptual frameworks, objectives, strengths, limitations and weaknesses, in order to achieve a conglomerate consortia of the various research initiative and projects related to senescence in Homo sapiens. Prospectively, further approaches to mitigate senescence would probably ensue, such as, but not confined to genetic and genomic interventions to circumvent telomere attrition, in addition to the modification of gut microbiota. I have followed, examined, reviewed and analyzed several given studies that have demonstrated that age-related alterations in the microbiota of the cells, tissues and organ systems of Homo sapiens has probably been implicated in the initiation, propagation and sustenance of age-related pathologies ,in addition to the senility process as a pathological entity. ANTI AGING PHARMACOTHERAPEUTIC AGENT SCIENTIFIC DEVELOPMENT SEQUENTIAL PHASES Conclusive Remarks and Recommendations Taurine like other candidate pharmacotherapeutic agents will be mandated to espouse reasonable safety and efficacy in the intended elderly community and the benefits of its use must equitably outweigh the risks of its use, before it will be approved by the FDA modulatory frameworks. Rigorous and stringent statutory benchmarks direct the processes of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical agents and Taurine will not be exempted from this. As a novel pharmaceutical antiaging agent, the evaluation and monitoring of Taurine’s efficacy and safety characteristics and profile will be sustained following its approval and through its post-marketing pharmacovigilance activities. Besides its enormous potential for scientific, empirical and serendipitous application as a plausible therapeutic agent in paediatric and adult geriatrics, Taurine could equally find application in other related or unrelated pathologies through serendipity, in addition to experimental and computational repositioning and repurposing derived approaches. BIBLIOGRAPHY, REFERENCES AND SUGGESTIONS FOR FURTHER READING. Bibliography, References and Suggestions For Further Reading. 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