Читать книгу Biopharmaceutics - Группа авторов - Страница 44

Pharmacokinetic studies are useful to study the absorption, metabolism, distribution and elimination of drugs. For biopharmaceutics, they are used predominantly to better understand absorption; in particular, how formulation or physiological properties affect the absorption of a particular drug and implications in bioavailability, biowaivers and establishing bioequivalence. The correlation between in vivo pharmacokinetic data and in vitro or in silico data is critical in the development of drug products. Typically, pharmacokinetic studies are conducted in animals during the preclinical development phase prior to the ‘first in‐human’ trials or the pharmacokinetic assessment during Phase I clinical trials.