(1) Is there an expectation from FDA that the bioanalytical methods/validation reports for
human sample analysis (in support of clinical studies) are also included in the IND, or is (2) it sufficient to just describe these methods in the relevant Module 2 sections?
Yes to (1) as explained in
the FDA's recent guidance (e.g., an overall summary for your method validation report showing a biological matrix) superseding the Guidance originally issued in 2001.
However, even if the answer to (2) is Yes, I highly recommend you perform some studies using human specimens as part of your method validation. Without such studies, it is risky and unpredictable.
Your summary should be included in Mod II.
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President and Principal
http://www.regulatorydoctor.com Riner VA
United States
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Original Message:
Sent: 03-14-2014 09:18
From: Bernard Delaey
Subject: Bioanalytical method validation reports in IND submission
For nonclinical studies with biologicals, full bioanalytical method reports and method validation reports (e.g. for PK and anti drug antibody analysis) are included with the initial IND submission in Module 4. Is there an expectation from FDA that the bioanalytical methods/validation reports for human sample analysis (in support of clinical studies) are also included in the IND, or is it sufficient to just describe these methods in the relevant Module 2 sections?
thank you
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Bernard Delaey PHD
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