PK Evaluation of lead compounds in preclinical species Data uses for CMC optimization.
- In vivo pharmacokinetic (PK); study changes in drug concentration with time, usually in blood or plasma, following dosing.
- Acute PK: Exploratory or Basic PK parameters: Blood/Plasma sampling.
- Complete PK profiling: Exposure parameters, Bioavailability, Dose proportionality, Tissue distribution, Brain-to-plasma ratio, Bioequivalence, Single vs. multiple dosing, Metabolite profiling
- PK/PD assessment: Toxicokinetic (TK) evaluation