Biopharmaceutics classification system (BCS) as a framework for selective approach to bioavailability/bioequivalence (BA/BE) investigation
Year: 2006
Type: article
Abstract: One of fundamental investigations, that pharmaceutical industry is expected to conduct during development of pharmaceutical formulation in order to prove its efficiency and safety, is bioavailability (BA), or bioequivalence (BE) assessment. Traditional approach to this investigation entails strictly controlled, expensive and time consuming study in humans. The potential for considering drugs' in vivo behavior has been extended and new selective approach has been set by development of Biopharmaceutics Classification System (BCS) and evaluation of drug absorption according to solubility and permeability properties of the drug, as well as its dissolution from pharmaceutical preparation. Manufacturers are particularly interested in creating criteria based on BCS concept for granting waiver of BA/BE studies for Immediate Release Products (IRP), aiming for reduction of time and cost of drug development process. These criteria have been discussed at many experts' meetings lately, and regulatory agencies are expected in near future to consider proposals for changes in regulative requirements according to the results from practice. If some of them were accepted, BCS would become even more significant as a powerful tool in drug and pharmaceutical preparation development process.
Source: FarFar - Pharmacy Repository
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W2590412697