Drug Development 1

The aim of this course is to apply prior knowledge of drug discovery in the critical evaluation of the major phases of the drug development process and be able to discuss strengths and weaknesses of a new drug program. Assessing drug safety, Investigational New Drug (IND) application, and the design and evaluation of ‘first time in man' studies; clinical imaging for drug development; formulating medicines for clinical development; Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP); overview of the aims and objectives of Phase 1, 2 and 3 of drug development; factors leading to continuance or discontinuance of drug development at each phase; incorporating preclinical knowledge; evaluating the pharmacokinetics, clinical effectiveness and safety of new drugs during Phase 1-3; measuring clinical benefit and the use of surrogate markers of drug efficacy and safety; regulation of phase 1-3 studies and ethical requirements; obligations of a sponsor; the costs of drug development.