Guidance on triggers for inspections of bioequivalence trials

European Medicines Agency, Guidance on triggers for inspections of bioequivalence trials, EMA/244111/2013, www.ema.europa.eu
The following checklist is designed to be used by assessors when reviewing bioequivalence studies. Missing documentation should first be solved through questions to the applicant. If triggers are identified after the completion of the checklist which have a major impact on the quality of the data and may result in a potential serious risk to public health, the assessor is advised to have further discussions with their GCP Inspectorate. This document re-presents a non-exhaustive overview of issues which are taken into account during the assessment phase. Identification of other triggers not mentioned in this document is possible.

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