• Fda Bcs Guidance

INTRODUCTION The FDA’s Biopharmaceutics Classification System(BCS) is based on the work of Amidon and coworkers with the core idea being that in vitro methodology, centrally embracing permeability and solubility, with qualifications related to pH and dissolution, may qualify drug products for a waiver of in vivo bioequivalence studies. The objective of the BCS is to predict in vivo performance of drug products from in vitro measurements of permeability and solubility. In 2005, Wu and Benet recognized that for drugs exhibiting high intestinal permeability rates the major route of elimination in humans was via metabolism, while drugs exhibiting poor intestinal permeability rates were primarily eliminated in humans as unchanged drug in the urine and bile. They proposed that a biopharmaceutics drug disposition classification system (BDDCS) could serve as a basis for predicting the importance of transporters in determining drug disposition, as well as in predicting drug-drug interactions. The major differences between BCS and BDDCS relate to their purpose and the measurement for classification as depicted in.

Fda Bcs Guidance

Classification of APIs according to the BCS According to the HHS-FDA definitions in the documents cited above, the four different categories possible for an API according to the BCS are: • BCS class I: “high” solubility – “high” permeability • BCS class II: “low” solubility” – “high” permeability. The Biopharmaceutics Classification System or BCS was proposed in 1995. According to the HHS-FDA definitions in the documents cited above, the four.