Bioequivalence and Bioavailability Forum

Dear Sir/ Madam,

If we have conducted fed and fasting study in one site and the sponsor wants to continue the study with remaining IPs in another site with the same test and reference in which there is shortage of any of the IPs. For example if sufficient amount of test is not available in required quantity (for retention) for upcoming study. Can we proceed with new shipment of IPs provided by sponsor as second shipment (in which only 1 container will be provided for conduct of study) only for the conduct of study and considering the retention samples from first shipment. Kindly provide your opinion regarding this scenario. Also kindly opine whether this single container can be used for study or need to be retained as retention sample with out using for the study.

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Edit: Category changed; see also this post #1. [Helmut]