Abstract
The Biopharmaceutical Classification System (BCS) has been used as a predictive method to evaluate potential formulation impacts on oral medication bioavailability in humans. The BCS can assist in the prediction of in vivo product performance and the construction of mechanistic models that enable formulation assessments through the generation of scenarios when used in conjunction with in vitro dissolution testing. The applicability of current human BCS standards has not yet been examined in dogs, which restricts its application in canine medication development. The BCS has had a significant impact on drug discovery, development, and regulation on a global scale and the BCS continues to receive much validation, discussion, and extension in the literature. Drug regulatory organizations from all across the world have fully deployed the BCS when establishing bioavailability/bio-equivalence requirements for the approval of oral drugs with instant release (IR). In this study, we examine the provisional BCS classification of the most popular medications sold worldwide and discuss the BCS scientific framework and its influence on regulatory exercise of oral medicinal products. Also mentioned is the Biopharmaceutical Drug Disposition Classification System and how it relates to the BCS.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
