International Journal of Drug Regulatory Affairs
Year : 2019, Volume : 7, Issue : 3
First page : ( 14) Last page : ( 20)
Print ISSN : 2321-2162. Online ISSN : 2321-6794.
Article DOI : 10.22270/ijdra.v7i3.329

Types of biowaivers: A discussion

Sarkar Atreyee*

Clinical Research Department, Micro Labs Limited., 58/3, Singasandra Post., Kudulu, Bangalore, India, 560 068

*Corresponding author Tel.: +91-8049516159, E-mail address: atreyeesarkar@microlabs.in (A. Sarkar)

Online published on 24 May, 2021.

Abstract

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 application well established use application also known as bibliographical US 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 Union European application Australia. Well established use Europe literature based submission is acceptable if the drug product is available in the market for at least ten years. The latter are acceptable by Australia only. This review discusses various types of biowaiver applications accepted by the regulated markets.

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Keywords

Biowaiver, Biopharmaceutics Classification System (BCS), Bioequivalence, Bioavailability study, Bibliographic Application, Solubility, Permeability, Literature Based Submissions (LBS).

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