Q1 / Q2: CFR 320 may be of some help [Regulatives / Guidelines]

posted by luvblooms  – India, 2015-05-04 08:55 (3570 d 11:45 ago) – Posting: # 14747
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Hi John


❝ Does anyone know if there is some kind of FDA guidance on Q1 and Q2? I searched around and only find bits and pieces of information...


As of now even I am not aware of any specific Q1/Q2 guidance but there are sufficient information available in CFR's.

Do check these links
  1. Excipients: A Regulatory Support Prospective: Many CFR links are given for Solution, opthalmics and injections

  2. Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

  3. 21 CFR 320.22 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalence

Hope this would be of some help!!!

~A happy Soul~

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