(2003; 148 pages)
13.1 Proposal to the WHO Expert Committee by the Scientific Working Group on Bioequivalence of the International Pharmaceutical Federation (FIP)
The Committee was informed of the joint work between WHO and the International Pharmaceutical Federation (FIP) on the development of a biopharmaceutical classification system (BCS) for assessing the reliability of in vitro dissolution testing as a surrogate for the in vivo bioequivalence testing of immediate-release (IR) solid dosage forms.
The Committee agreed that this work was particularly important for ethical reasons and that it reduced costs of analysis. It therefore endorsed WHO’s participation in further work in this area.