Bioequivalence and Bioavailability Forum

Plasma sample storage duration from USFDA per­spective [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2014-03-24 18:10 (4481 d 16:14 ago) – Posting: # 12695
Views: 3,756

Dear Keath,

please  search the forum in the future.
There are no regulatory requirements published by the FDA (and EMA as well). Going beyond the validated long-term storage is of limited value. However, we kept complete samples of one subject for infinite time as some kind of proof that the study was not fabricated.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Plasma sample storage duration from USFDA per­spective Keath 2014-03-24 10:00 [Regulatives / Guidelines] 
  • Plasma sample storage duration from USFDA per­spectiveHelmut 2014-03-24 17:10
    • Plasma sample storage duration from USFDA per­spective Keath 2014-03-25 05:05
  • Plasma sample storage duration from USFDA per­spective AngusMcLean 2014-03-26 20:26
    • Plasma sample storage duration from USFDA per­spective Keath 2014-03-27 05:18
      • Plasma sample storage duration from USFDA per­spective Ohlbe 2014-03-27 10:35