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Department of Pharmacology & Systems Physiology

Master’s Program in Pharmacology

Course Descriptions (required coursework)

Pre-Clinical Good Laboratory Practice (MCBP7001) -

The course will review the history of GLP in drug development; general provisions of CFR21, part 58; organization of a GLP unit and required training of personnel; setting up of a drug testing facility; standard operational procedures of the testing facility; procurement, determination of purity, handling and storage, preparation and stability of the test article (new drug); standard operating procedures and protocols of experiments; and recording, storage and reporting of data. The course will also include basis for disqualification or suspension of a testing facility by FDA and the appeal process for reinstatement or final disqualification or suspension. Students will also be taught how to inspect a GLP compliant drug testing facility and how to prepare a high qualify final study report.

Pre-Clinical Drug Toxicology (MCBP7002) -

The course will cover all aspects of the rationale and purpose of preclinical toxicology studies of new drugs under development. It will also cover requirements regarding establishment of a compliance research facility/laboratory and identify required practices for preclinical toxicology studies of therapeutic agents intended for human use. Emphasis will be placed on organization, process and conditions under which laboratory studies must be conducted to satisfy US FDA requirements for preclinical toxicology studies of a new drug.

Experimental Methods in Safety Pharmacology (MCBP7003C) -

This course intends to provide students with the knowledge of the purpose of preclinical drug safety studies, the methods used and the principles of contemporary methods of specific organ system effects of drugs at therapeutic and toxic levels in the preclinical phase of development as set forth in the International Committee on Harmonization (ICH) guidelines. The course will cover the rationale, purpose, principles and all aspects of experimental methods and procedures employed for preclinical drug safety studies recommended by ICH and required by FDA before first administration of a new drug to human subjects.

New Drug Discovery and Development (MCBP7010) -

The course provides knowledge of the current and, future trends in new drug discovery, including, both chemical and biological molecules, in the context of contemporary and emerging technologies, discovery strategies, and the overarching drug discovery paradigm. The course will explore safety, efficacy and toxicology regulatory guidelines developed by the International Committee on Harmonization, under the Code of Federal Regulations for the US Food and Drug Administration, and as promoted by the international Safety Pharmacology Society. The course explores all phases of new drug discovery and pre-clinical development leading to first-in-human clinical trials.

Principles of Safety Pharmacology (MCPB7020) -

This course provides a general introduction and orientation to the field of safety pharmacology. This area of applied pharmacology has in the last decade become essential to drug development and regulatory approval throughout the developed world. Also known as secondary or off-target pharmacology, safety pharmacology explores the effects of drugs and candidate drugs on essential pharmacological and physiological systems (e.g., cardiovascular system, central nervous system, and respiratory system) that may lie outside their intended target systems. Safety pharmacology studies are necessary before Phase I clinical trials as well as throughout drug development. The focus of the course will be on overview, principles, and regulatory aspects of the field. The course helps prepare graduate students who plan to work in government regulatory agencies (e.g., the US Food and Drug Administration) or the private sector (e.g., pharmaceutical companies or contract research organizations).

Advanced Safety Pharmacology (MCBP7021) -

This course is intended to provide specific training in the field of safety pharmacology. Also known as secondary or off-target pharmacology, safety pharmacology explores the effects of drugs and candidate drugs on essential pharmacological and physiological systems (e.g., cardiovascular system, central nervous system, and respiratory system) that may lie outside their intended target systems. The core systems and the specific assays required for Investigational New Drug applications will be discussed in detail.

Laboratory Rotation (MCBP8001) –

 MS students will work in a research laboratory to familiarize themselves with research techniques. A series of laboratory rotations may be used to explore laboratory choices or a student may continue in the same lab to develop laboratory skills as well as specialized techniques.

Seminar (MCBP8005) –

A faculty-guided seminar-style class which includes seminar presentation, group discussion and written critiques of presentations. Graduate students in Pharmacology participate in seminar each term.

Systems Pharmacology (MCBP8027) –

The course will provide students with a solid foundation in pharmacology, drug classes, exemplars, and mechanics of action and organ system applications.

Pharmacological Principles and Receptors (MCBP8031) –

Fundamentals of pharmacodynamics, pharmacokinetics, and drug absorption, distribution, metabolism and elimination, as well as theories underlying and applications of dose-response curves and radioligand binding experiments are covered.

Ethics in Research (GNTD7003) –

This course introduces students to ethical theories generally and the ethical and regulatory issues they are likely to encounter as researchers. Student will learn to identify issues, analyze ethical issues in research and to develop coherent justifications for their ethical and responsible conduct of research.

Electives:

Elective courses are offered in our department and other departments across the College of Medicine. MS students select a minimum of one elective per semester to fulfill credit hour requirements for degree completion.
Cleanroom Facility

Students prepare for an on-site visit to an Aseptic Processing Laboratories, an ISO Class 7 and 8 cleanroom facility for the manufacture of GMP-grade viral vectors and manipulation of GMP/GTP-grade cellular products for phase I/II Clinical Trials in compliance US federal and European guidelines.