As stated in 21 CFR 312.38
Retention of bioavailability samples, samples need to be retained if:
1. the test article is compared to a reference oral solution, suspension or injection
2. the formulation differs from the formulation used in clinical studies to establish safety and effectiveness, or
3. the test article is a new formulation, dosage form, salt, ester that differs from an approved formulation.
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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 03-Jan-2019 11:54
From: Anonymous Member
Subject: Retaining PK Samples
This message was posted by a user wishing to remain anonymous
Dear Experts-
What types of PK studies should the sponsor retain PK samples for?
Thank you for your help!