Farmacocinética no Desenvolvimento de Medicamentos - Fful

Objectives

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.

Syllabus

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 proportionality. 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:

Prerequisites

Any student that has been admitted to the following 2nd Cycle programmes are elligible to take this course: MEFARM, MEQ, MEBIOL, MEBIOM or MEAMBI.

Cross Competence Component

This unit provides the skills necessary to be able to read, navigate and understand international GMP and Quality Systems legislation, across multiple regulatory regions, as a function of quality culture differences and its relation to patient safety, assurance in terms of therapeutic efficacy and their relation to product quality.

Programming And Computing Component

Advanced use of Excel (e.g., Solver for kinetic modelling) and the use of specific software, such as Berkeley-Madona (some basic programming for solving differential equations for kinetic modeling)

Ethical Principles

All members of a group are responsible for the group’s work In any assessment every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be alble to present and answer questions about the entire assignment and solution.