I assume you are referring to PK samples that are collecting during the study to document exposure? I am not aware of a requirement to retain samples for any PK study other than bioavailability and bioequivalence.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 24-Jun-2020 18:05
From: Anonymous Member
Subject: Thorough QTc Samples
This message was posted by a user wishing to remain anonymous
Hello!
How long should a sponsor retain the samples from the QTc study?
Any advice is greatly appreciated!
Kind Regards.