Investigational Products for BA/BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2005-10-19 13:22 (6361 d 14:09 ago) – Posting: # 43
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'Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format' (Draft Guidance, 2004-05-12) states:

Retention of Samples
It is recommended that samples of the test and reference drug products used in the comparative bioavailability study(ies), and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn.

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