BCS & Biowaivers

Evaluation of the In Vitro Dissolution and Absorption (IDAS2) as a potential surrogate for in vivo performance of drug formulations

Evaluation of the In Vitro Dissolution and Absorption (IDAS2) as a potential surrogate for in vivo performance of drug formulations Johayra Simithy1, Carlos Jiménez-Romero1, Geraldin Martínez1, Andrea Pravia1, Jibin [...]

What you need to know about BCS Biowaivers: Regulatory Requirements and Approval Process

Find answers to FAQ's, such as: When are they applicable? Does it apply to prodrugs? How is it used for Class I new drugs? ..and many more. View [...]

2016-12-27T07:37:55-04:00October 22, 2015|Categories: BCS & Biowaivers|Tags: , , |