The FDA has laid out specific guidelines regarding the collection and storage of Retention Samples from Bioavailability (BA) and Bioequivalence (BE) studies. They have specifically indicated that reserve samples NOT be sent back to the Study Sponsor and/or Drug Manufacturer. The goal is to eliminate the possibility for sample substitution by the Sponsor and/or Manufacturer, and to preclude the alteration of a reserve sample from a study conducted by another entity before the release of the reserve sample to the FDA. 1
Leake works as an Independent Third Party, holding retention samples in our secure facility, maintaining the environmental requirements required for product integrity.
1 "Guidance for Industry Handling and Retention of
BA and BE Testing Samples", CDER/FDA, May 2004,
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