A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme

A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme

The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowa...

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Published in:Journal of pharmacy & pharmaceutical sciences Vol. 21; no. 1; pp. 27 - 37
Main Authors: Van Oudtshoorn, Joy Elizabeth, García-Arieta, Alfredo, Santos, Gustavo Mendes Lima, Crane, Christopher, Rodrigues, Clare, Simon, Craig, Kim, Ji Myoung, Park, Sang Aeh, Okada, Yusuke, Kuribayashi, Ryosuke, Pfäffli, Chantal, Nolting, Arno, Lojero, Iván Omar Calderón, Martínez, Zulema Rodríguez, Hung, Wen-Yi, Braddy, April C, Leal, Nancy Arciniegas, Triana, Diego Gutierrez, Clarke, Mitch, Bachmann, Peter
Format: Journal Article
Language:English
Published: Canada Frontiers Media S.A 01-01-2018
Online Access:Get full text
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Summary:The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowaivers are interpreted and regulated differently among international regulatory agencies. In this survey, the Bioequivalence Working Group (BEWG) of the International Generic Drug Regulators Programme (IGDRP) compared the criteria for BCS-based biowaivers applied by the participating regulators and organisations. Differences and similarities regarding solubility, permeability, dissolution, excipients and fixed-dose combination products, were identified and compared in a detailed survey of each participant's criteria for BCS-based biowaivers. These criteria were determined based upon the participants' respective regulatory guidance documents, policies and practices. This review has, with the exception of two participants who do not accept BCS-based biowaivers, revealed that most IGDRP participants interpret the BCS principles and conditions similarly but notable differences exist in the application of these principles.  Conclusion: Although many similarities exist, this review identifies several opportunities for greater convergence of regulatory requirements amongst the surveyed jurisdictions. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.
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ISSN:1482-1826
1482-1826
DOI:10.18433/J3X93K