Master in Pharmaceutical Engineering

6

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 singledose and multipledose 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.

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.