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FACULTY OF PHARMACY
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Outcome of Module 2: Non-clinical, pharmaceutical and early clinical development
Choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds.
Integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials).
Steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds).
Planning of clinical trial supplies for test substance and comparators (active and placebo).
Overview of non-study requirements prior to First-into-Man studies.
Molecular and cellular basis of toxic reactions.
Principles and practical application of pharmacokinetics and toxicokinetics.
Early exploratory development in man.
Principles of clinical pharmacology and their application to clinical development.
Influence of genetic factors in drug development and drug response.