The Biopharmaceutics Classification System, or BCS, is a framework for classification of drugs according to two fundamental properties of the drug substance, i.e., permeability and solubility.
The BCS class of a drug substance has important implications for formulation development, and a BCS-based biowaiver can eliminate the need for clinical bioequivalence studies, which would otherwise be required for changes in formulation, manufacturing site, or manufacturing method.
High permeability can be demonstrated either in vivo or in vitro; the latter can be faster and cheaper, especially for drugs subject to first-pass metabolism or with high inter-subject variability. This webinar will cover the basics of the BCS as well as nuances that are not included in the FDA’s BCS guidance, learned from interactions with the FDA in support of dozens of biowaiver applications.
In this webinar you’ll learn:
• Why it’s important to know the BCS class of a drug;
• The significance of the BCS for both generic drugs and NCEs;
• The importance of an accurate high-permeability internal standard for comparison with a test drug for in vitro permeability classification;
Who should attend:
• Formulation scientists
• Pharmacokinetics experts
• Pharmaceutical product managers