PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9127.

This course forms a bridge between PHAR9101 (Principles of Drug Action) and PHAR9120 (Clinical Development of Medicines). The principles introduced in PHAR9101 are extended to include pharmacodynamics and a review of the major classes of pharmacological substances including those acting on the central and peripheral nervous systems and the major organ systems such as cardiovascular, pulmonary, renal, etc. Clinical uses and limitations of the drugs are summarised and examples given showing the application of pharmacodynamic and pharmacokinetic principles to clinical situations. Laboratory and clinical methods are reviewed. The focus is on the validation of analytical methodologies, and the role and limitations of animal models of disease, as a basis of understanding how drug efficacy and safety are assessed in the laboratory and in clinical settings. Systematic non-clinical safety assessment is then reviewed. This covers: (a) aims and definitions of safety assessment programs; (b) design and execution of toxicological studies; (c) special studies such as carcinogenicity, mutagenicity and reproductive studies; (d) toxicokinetics; (e) design and interpretation of toxicological studies; and (f) safety pharmacology. The course concludes with an introduction to Good Manufacturing Principles (GMP)and the preparation of drug supplies for use in early development testing.

Note: The course is compulsory for programmes 7370, 5504, and 9060.