How several number of unused and reconsituted sample do we obligation to retain after phase II or III clinical trial?
And how long should we keep them?
Answers:
Since you're within clinical trials, you fall below GCP guidelines rather than GMP. From what I've be able to find, the amount of reserve samples should be adequate to permit the Agency to carry out five times all of the release test required in the application or supplemental application. The guideline bulletin I've associated to below doesn't specify a time period, so one would assume one would retain them indefinitely, as long as the drug beneath trials was contained by submission to the FDA. Once approved by the FDA, your research data and adjectives samples dive under GMP guidelines, where on earth the retention requirements are a little different.
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