Journal of Pharmaceutical Research

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Biowaivers-An Updated Review


Affiliations
1 Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, India
 

PURPOSE: A Biowaiver has been regarded as an official approval of the waiver for conducting a bioequivalence study in the context of an application for drug approval process. Bioequivalence is an important parameter in the process of drug development that is needed to be performed when there is a change in the formulation of dosage form.

Approach: The approach of biowaivers is necessary to waive a complete and systemic Bioequalence study, which as a fast track approach to boost the drug development process.

Findings: This review mainly discusses about the criteria for Biowaivers, requirements for a BCS based biowaiver study, conditions to grant the BCS based biowaiver, Applications, limitations, supporting data for Biowaivers.

Conclusion: BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.


Keywords

Biowaivers, BCS Class, BABE Studies, Drug Development.
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  • Biowaivers-An Updated Review

Abstract Views: 204  |  PDF Views: 68

Authors

N. Abilash
Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, India
R. Chandramouli
Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, India

Abstract


PURPOSE: A Biowaiver has been regarded as an official approval of the waiver for conducting a bioequivalence study in the context of an application for drug approval process. Bioequivalence is an important parameter in the process of drug development that is needed to be performed when there is a change in the formulation of dosage form.

Approach: The approach of biowaivers is necessary to waive a complete and systemic Bioequalence study, which as a fast track approach to boost the drug development process.

Findings: This review mainly discusses about the criteria for Biowaivers, requirements for a BCS based biowaiver study, conditions to grant the BCS based biowaiver, Applications, limitations, supporting data for Biowaivers.

Conclusion: BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.


Keywords


Biowaivers, BCS Class, BABE Studies, Drug Development.

References