Master in Regulation and Evaluation of Medicines and Health Products

4

To understand and critically evaluate the planned pharmacokinetic studies needed in the development of a new medicine, namely:

• Evaluation of the dose to be used in clinical studies
• Design of single-dose and multiple-dose studies
• Kinetic characterization of drug absorption, distribution, metabolism and excretion
• Evaluation and characterization of pharmacokinetic variability and identification of the relevant factors (intrinsic and extrinsic) for PK variability.

Compartmental models; pharmacokinetic parameters. Single-dose and multiple-dose kinetics.
Fundamental studies: “first time in man” 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 proportionality. Non-compartmental approach. Modelling. 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. Summary of Product Characteristics.
Pharmacokinetic variability. Intrinsic factors: renal impairment and hepatic impairment. Gender, age, weight, race. Extrinsic factors: drug-drug interactions. Food effect. Population Pharmacokinetics.