Sadmin exam 1

Suchman's Model of Stages of Illness Behavior

Parson's sick role

-a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

the finished dosage form, e.g., tablet, capsule, soluiton, that ocntains a drug substance (the active drug ingredient), generally, but not necessarily, in association with inactive ingredients.

-understand the disease

-identify the underlying cause of the disease

-choose a molecule to target with a drug

-important to pick a target that is "drugable"- one that can potentially interact with and be affected by a drug molecule.

-test the target and confirm its role in the disease

-show that the target is actually involved in the disease and can be acted upon by a drug

involves laboratory and animal testing (in vitro and in vivo) to ensure that the drug candidate is safe for human testing

How many compounds survive the pre-clinical phase?

a request for FDA authorization to administer an investigational drug to humans (prior to clinical trials).

Authorization must be secured prior to interstate shipment and administration of any new drug. T/F?

sponsors who ultimately want to market the drug (e.g. pharmaceutical or biotech companies)

anyone who will not be marketing the drug (e.g., physician)

submitted by physician who both initiates and conducts an investigation

when experimental drug is needed for an urgent medical situation (life threatening)

for use of promising experimental drugs in clinical testing for grave conditions. Allows drug to be available to patients in need before the drug is approved for marketing.

a board that ensures the rights and welfare of clinical trials to participants; reviews all aspects of study, ensures participants are fully informed and provide their written consent

IRB applications don't have to be filled at clinical trial sites. T/F?

-involves very limited human expose (<10 patients)

-permits limited dose quantity "microdosing."

-not intended to have therapeutic effect

-drug tested in small group of healthy volunteers for the first time

-main purpose is to determine if the drug is safe in humans

-20-100 healthy volunteers

-drug tested in diseased patients for the first time

- purpose: determine drug effectiveness

-100-500 patients with disease under study

-test in a large group of patients to show safety and efficacy

-purpose: establish the risk-benefit profile

-sample: 1,000-5,000 diseased patients

-study design: random, doubled-blinded, controlled study

-filed once drug passes all stages of clinical trials

-must demonstrate benefits outweigh any risks

-preclinical and IND human trial data to be submitted as part of the NDA

-NDAs only required to establish drug safety

-required NDAs to contain evidence of drug effectiveness for its intended use

-to establish that benefits outweigh risks

-comparable bioavailability (rate and extent of absorption of drug)

same active ingredients, dosage form, route of administration, dosage strength

-expedites generic drug availability

-first generic gets 6 months exclusivity

-clinical trials: 24-36 healthy volunteers

-allows for unapproved products or approved products to be used for unapproved treatments

-must be reasonable to believe that the treatment is effective