Points to consider for inspections of biowaiver data

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16 December, 2010 - 08:00 (CET)

Medicine Update

The WHO Prequalification of Medicines Programme (PQP) intends to include in its inspection programme, sites that have performed comparative dissolution studies submitted in product dossiers by applicants in support of requests for biowaivers (i.e. waivers of the necessity to perform clinical bioequivalence studies).

A guideline document — Points to consider for inspections of biowaiver data — can be consulted on this website. It is not exhaustive, but reflects elements that may be considered for inclusion during WHO inspections of sites that have performed comparative dissolution studies for Biopharmaceutics Classification System (BCS)-based and additional strength biowaivers.

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