Pharmacokinetics represent an important link through all research and development phases. From early in-vitro models for absorption and metabolism through animal experiments for drug exposure (e.g. in toxicology) until the specific aspects of clinical studies, especially in Phase I. Specific biopharmaceutical aspects are in-vitro/in-vitro-correlation and bioequivalence which may be relevant in case of life cycle management activities. By new Phase 0 studies important pharmacokinetic data for the selection of drug candidates can be generated. Complete pharmacokinetic characterisation requires validated robust bionalytical methods.
- Pharmacokinetic investigation programs for preclinical and clinical phases
- Design, evaluation and reporting of pharmacokinetic/-dynamic studies in-vitro and in animal and man using labelled and non-labelled material for all phases
- In-vitro model for absorption and metabolism
- Bioavailability and bioequivalence
- Concepts for bioanalytical method development, validation and evaluation
- Pharmacokinetics in special populations (age, disease, liver -, renal insufficiency)
- Assessment of pharmacokinetic profile of research/development candidates