Interchangeability of pharmaceutically equivalent multisource drug products can be evaluated by bioequivalence studies. Generally pharmacokinetic, pharmacodynamic or clinical studies involving human subjects are used for bioequivalence evaluation. However, improved understanding of the biopharmaceutical and clinical parameters of drug products has helped pharmaceutical scientists to utilize in vitro dissolution testing as a method to evaluate bioequivalence in lieu of in vivo bioequivalence studies. The term “biowaiver” is used to describe the use of surrogate in vitro method to waive the need for in vivo assessment. The concept of biowaiver is based on the Biopharmaceutics Classification System (BCS) and evaluates the biopharmaceutical and clinical parameters of the active pharmaceutical ingredient and the drug product along with the risks associated with the decision of bioequivalence based on in vitro method. Biowaiver approach provides the advantage of circumventing expensive and time consuming in vivo human studies thus reducing the time to bring multisource drug product into the market. |
