To understand and critically evaluate the planned pharmacokinetic studies needed in the development of a new medicine, namely:
Pharmacokinetics: Compartmental models; pharmacokinetic parameters. Singledose and multipledose kinetics. Fundamental studies: “first time in man” study: conditions for the conduct of this study. Dose selection. Bioavailability and Bioequivalence (BD/BE): Absolute bioavailability. Basic concept and evaluation. Study design and conduction.
Analysis and interpretation of results. Biowaiver. In vitro/in vivo correlations (IVIVC). Mass balance studies and ADME.
Dose proportionallity. Noncompartmental approach. Modelling in Pharmacokinetics. Absorption kinetics: prediction and data analysis.
Basic concepts in Clinical Pharmacology: different phases in the clinical study of a new medicine. Clinical trials: study type, study conduct and data evaluation. Clinical protocol. Good Clinical Practice (GCP). Summary of Product
Characteristics (SPC).Pharmacokinetic variability. Biological medicines.