Introductory course in exploratory medicines development, Part II Back
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products.
Two training parts of 3 days each (Parts I and II) provide a concise overview on human pharmacology / translational medicine spanning from non‑clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials.
Part II provides an introduction into early / exploratory trials in healthy subjects and patients with a special focus on molecular basis of drug action, pharmacodynamics (endpoints, biomarker), risk assessment and determination of first dose as well as deeper insights in pharmacokinetics. Case studies will be presented and discussed/resolved by the participants in small break out groups. Basic principles of data management, statistical analysis and reporting will be presented. Overview will be given on development of biosimilars.
On successful completion of Part II, students should be able to demonstrate an understanding / knowledge of the following aspects:
- nonclinical pharmacology and toxicology
- molecular basis of drug actions
- allometric scaling and dose proportionality assessments based on characteristic PK data
- defining pharmacodynamic (PD) endpoints and biomarkers
- differentiating between primary and secondary PK and PD endpoints
- method validation according to good clinical (GCP) and good laboratory (GLP) practise
- planning and management of a first-in-man trial
- practical aspects of bioequivalence trials
- principles of data management and information flow
- principles of reporting and publication
- principles of medical statistics
- characteristic issues involved in the development of biologicals and biosimilars