The Online Master of Science in Pharmaceutical Sciences
with a Specialization in Drug Development
Program Overview
Overview
The University of Cincinnati offers an Online Master’s Degree program with a
concentration in Drug Development which provides students the opportunity
to understand, evaluate, and engage with the revolutionary process of drug
discovery and development.
Students will gain practical experience and knowledge while implementing
strategies in the areas of: global regulatory affairs, pre-clinical and clinical
pharmacology, clinical trials and research, medical devices, , product
development and life cycle management, pharmacoeconomics, and
pharmaceutical project management.
The objective of the online Masters of Pharmaceutical Science with a
concentration in Drug Development is to:
Our online MS program in Pharmaceutical Science with a concentration in
Drug Development integrates: the multidisciplinary aspects of the discovery
and development of new therapeutic agents including biologicals. Students
will explore (1) the global regulatory frame work for the development of
drugs/bio therapeutics and devices, (2) key concepts of lead optimization in
pre-clinical stages, (3) intricacies of early and late stage clinical trials
including rigorous statistical analyses, (4) the highest ethical standards in
clinical research with emphasis on human subjects protection, (5) global
standards for assessing safety during clinical trials and during post marketing
surveillance and (6) financial and economic aspects of drug development and
product launch.
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Our program prepares students to meet the needs for cross-disciplinary
training in scientific and regulatory aspects of drug development, global
regulatory affairs, and clinical trials management. Students will acquire
analytical and communication skills suitable for managerial and staff positions
in laboratory and clinical research, clinical trials, contract research
organizations, federal agencies for regulatory affairs, and pharmaceutical
marketing.
How to Apply to the Program
Applications for the online Master’s Degree program with a
specialization in Drug Development are accepted throughout the year.
Individuals are eligible to apply if they have earned a Bachelor of Sciences or
Arts degree in chemistry, biology, nursing or related discipline or a Doctor of
Pharmacy, Medicine or Veterinary Medicine from an accredited institution are
eligible to apply for admission to the MS/Ph.D. program in Pharmaceutical
Sciences.
Admission will be based upon evaluation of a completed University Graduate
Application inclusive of a CV, statement of purpose, all college transcripts with
evidence of high academic achievement (at least a B average), three letters of
recommendation and the Graduate Record Examination. For the past two
years, full-time admitted students' average GRE score was 1210/4.0; it is
recommended that a 300/3.0 be achieved on the new GRE.
All of the above mentioned application materials, except official transcripts,
must be submitted electronically on the University of Cincinnati Application
for Graduate Admission at
https://apply.uc.edu/OnlineApply/LogIn.iface?applicant=Grad.
Official transcripts must be mailed to:
Send transcripts to the Graduate School Office (P.O. Box 210627, Cincinnati,
OH 45221-0627)
Note: Please do not send directly to the College of Pharmacy as this may
cause a delay in processing your application.
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Additional Requirements for International Applicants
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The Test of English as a Foreign Language (TOEFL) is required of all
applicants whose native language is other than English. If you have a
bachelor degree or higher from a United States university, this
requirement will be waived. The minimum score for admission is 250
on the computer based test (CBT) and 100 on the Internet Based Test
The IELTS can be taken in place of TOEFL. The minimum required IELTS
score is 7.0.
Foreign applicants whose transcripts are not easily read may be
asked to submit a full evaluation of transcripts by a U.S. agency.
http://www.wes.org/educators/icap.asp is an option.
Program Requirements
A total of 30 credits are required for graduation
A written capstone project is required and must be focused on an area of
concentration within the pharmaceutical /drug development industry. The
capstone will be based on research (laboratory or otherwise) or maybe based
on a topic of relevant information acquired while attending the program.
Students may take classes without formal acceptance into the degree
program; however, it is recommended that not more than 12 credits be taken
prior to matriculation into the program.
Students may be able to complete the program in two years if at least 3
courses are take per semester and completed successfully.
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The Online Master of Science in Pharmaceutical Sciences
with Specialization in Drug Development
Course Offerings
PHDD8001
Seminar in Drug Development
The course will require the students to conduct an in-depth analysis on
current issues in drug development and apply the best practices in
making scientific presentations. Credit Level: G. Credit Hours: 3.00
PHDD8010
Global Regulatory and Development Strategies of Drugs & Medical Devices
Overview of research, legal regulatory and product life-cycle aspects
that impact decisions in global pharmaceutical product development.
Credit Level: G. Credit Hours: 3.00
PHDD8030
Pre-Clinical /Non-Clinical Studies for IND Approval
Principles and regulatory guidelines for pre-clinical evaluation of the
pharmacology, toxicology and pharmacokinetics of investigational drugs
and biologics and key elements of the Investigational Drug (IND)
application and Clinical Investigators brochures. Credit Level: G. Credit
Hours: 3.00
PHDD8040
Development and Manufacturing of Drug Products & Devices
The course provides an understanding of the role of formulation/dosage
form development in the overall scheme for new drug approval with an
emphasis on preformulation/formulation studies, current good
manufacturing practices and FDA/ICH guidelines for formulation
components, processes and equipment, stability testing programs and
overall quality assurance. Issues pertaining to the biopharmaceutics
classification system, special aspects of formulation of biologicals and
PHDD8050
Phase I/II Clinical Trials Research and Design
The role of Phase I trials in new drug development and approval with
emphasis on proof- of-concept and dose-ranging requirements. Trial
designs including cross-over and parallel group will be discussed. The
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importance of Phase II trials for making dose selections for Phase III will be explored.
Credit Level: G. Credit Hours: 3.00
PHDD8060
Statistical Principles in Clinical Research
Regulatory, statistical and operational issues in phase I trials will be
discussed. The use of first dose in humans, dose escalation schemes,
determination of maximal tolerated dose, mass balance, metabolism
and bioavailability will be covered along with drug-drug interaction and
food-effect studies. Credit Level: G. Credit Hours: 3.00
the impact of dosage form on drug disposition will also be underscored.
Credit Level: G. Credit Hours: 3.00
PHDD8070
Phase III /IV Clinical Trials & Research
The role of Phase III trials in drug development and approval.
Randomized controlled trial designs and factorial designs, selection of dose levels,
management of multi-center and multi-national trials,
population pharmacokinetics, choice of endpoints, surrogate endpoints,
and management of milestones and metrics will be discussed. Credit
Level: G. Credit Hours: 3
.PHDD8080
Pharmaceutical Economics & Management
This course will focus on management of the biotechnology,
pharmaceutical and contract research industries, including funding the
drug development process, competition, business, competition,
business models, intellectual property and funding of biotechnology.
Credit Level: G. Credit Hours: 3.00
PHDD8091
Drug Development Project I
A problem-based/hypothesis driven research project or a
comprehensive evaluation of a contemporary issue in drug/device
development that demonstrates competency in multidisciplinary didactic
coursework and scientific, regulatory and business aspects of new
product development. Credit Level: G. Credit Hours: 3.00
PHDD8092
Drug Development Project II
A problem-based/hypothesis-driven research project or a
comprehensive evaluation of a contemporary issue in drug/device
development that demonstrates competency in multidisciplinary didactic
coursework and scientific, regulatory and business aspects of new
product development. Credit Level: G. Credit Hours: 3.00
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For information Please contact:
The James L Winkle College of Pharmacy
3225 Eden Avenue
136 Health Professions Building
Cincinnati, Ohio 45267-0004
( 513) 558-3784 ( Drugs) or contact us on the web: pharmsci@uc.edu
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Course Offerings
Course#
Course Title
Semester Credits Fall Spring Summer Alt Yr
PHDD8001
Seminar in Drug Development
1
Y
PHDD8010
Global Regulatory and
3
Y
3
Y
Y
Y
Development Strategies of
Drugs and Medical Devices
PHDD8020
Discovery of Drugs and
Therapeutic Biologicals
PHDD8030
Pre-Clinical/Non-Clinical
3
Y
3
Y
Studies for IND Approval
PHDD8040
Development and
Manufacturing of Drug Products
and Medical Devices
PHDD8050
Phase I/II Clinical Trials
3
Y
3
Y
Research and Design
PHDD8060
Statistical Principles in Clinical
Research
PHDD8070
Phase III/IV Clinical Trials and
3
Y
3
Y
Research
PHDD8080
Pharmaceutical Economics and
Management
PHDD8091
Drug Development Project I
2
PHDD8092
Drug Development Project II
2
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Y
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The Online Master of Science in Pharmaceutical Sciences with Specialization in
Drug Development
Course Outline
Fall Semester (13FS)
Course #: PHDD8001
Course Title: Seminar in Drug
Development
Credit hours: 1
Spring Semester
Course #: PHDD8001
Course Title: Seminar in Drug
Development
Credit hours: 1
Course #: PHDD8010
Course Title: Global Regulatory and
Development Strategies of Drug and
Medical Devices
Credit hours: 3
Course #: PHDD8030
Course Title: Pre-Clinical /Non-Clinical
Studies for IND Approval
Credit hours: 3
Course #: PHDD8020
Course Title: Discovery of Drugs and
Therapeutic Biologicals
Credit hours: 3
Course #: PHDD8040
Course Title: Development and
Manufacturing of Drugs and Medical
Devices
Credit hours: 3
Course #: PHDD8050
Course Title: Phase I/II Clinical Trials
Research and Design
Credit hours: 3
Course #: PHDD8070
Course Title: Phase III/IV Clinical Trials
and Research
Credit hours: 3
Course #: PHDD8060
Course Title: Statistical Principals in
Clinical Research
Credit hours: 3
Course #: PHDD8091
Course Title: Drug Development
Project I
Credit hours: 2
Course #: PHDD8080
Course Title: Pharmaceutical Economics
and Management
Credit hours: 3
Total credits 15
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Summer Semester
Course #: PHDD8001
Course Title: Seminar in Drug
Development
Credit hours: 1
Course #: PHDD8092
Course Title Drug Development Project
II
Credit hours: 2
Total credits 15
Total credits 1
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