Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline

This document defines the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified release formulations following oral, intramuscular and subcutaneous administration and transdermal dosage forms in man. It aims to set out general principles for designing, conducting and evaluating such studies. The overview of comments would be soon available on this page.

Keywords: Modified release, prolonged release, delayed release, transdermal drug delivery systems (TDDS), bioequivalence, pharmacokinetics, biowaiver, in vitro dissolution, generics, oral, intramuscular, subcutaneous.