Types of Biowaivers: A Discussion

  • Atreyee Sarkar M.Pharm


The aim of the present review is to discuss the different types of biowaiver applications. Waiving of In vivo bioequivalence studies is known as biowaiver. Types of biowaiver applications include BCS based biowaiver, well established use application, also known as bibliographical application and Literature based submission. Biowaiver is acceptable for both BCS class I as well as class III drug molecules. These kinds of applications are generally submitted to countries like US, European Union and Australia. Well established use application and literature based submission is acceptable if the drug product is available in the market for at least ten years. The latter are acceptable by Europe and Australia only. This review discusses various types of biowaiver applications accepted by the regulated markets.

Keywords: Biowaiver, Biopharmaceutics Classification System (BCS), bioequivalence, Bioavailability study, Bibliographic Application, Solubility, Permeability, Literature Based Submissions (LBS)


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How to Cite
Sarkar, A. “Types of Biowaivers: A Discussion”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 3, Sept. 2019, pp. 14-20, doi:10.22270/ijdra.v7i3.329.