“Biowaiver for co-amoxiclav tablets”

N.ANANDHI wrote:
Thursday 02-08-2012

Is BCS based Bio-waiver applicable for registration of Co-amoxiclav tabs in EU?
( As per WHO, Amoxicill in class I and Potassium clavulanate is Class III drug)


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Replies to this question see below:
Alan wrote:
Wednesday 05-09-2012

Section V of appendix III of the EMEA's guidance document entilted "Guideline on the Investigation of Bioequivalence" indicates that "BCS-based biowaiver are applicable for immediate release fixed combinations (FC) products if all active substances in the FC belong to BCS-class I or III and the excipients fulfill the requirements outlined in section IV.2. Otherwise in vivo bioequivalence testing is required". Please refer to section IV.2 of the referred document for specifics around excipient requirements. Therefore, based on this guideline a biowaiver should be possible provided that all API's belong to BCS-Class I or III AND the requirements for excipients are fulfilled. This response is provided by the BCS & Biowaivers Special Interest group (SIG).