Bioequivalence and Bioavailability Forum • Required SOPs for BA BE unit by the FDA?

Required SOPs for BA BE unit by the FDA? [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2006-12-22 13:30 (7116 d 23:51 ago) – Posting: # 416
Views: 15,739

Dear sekhar,

you are referring to a drafted document:

❝ http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS05_120Rev1_CROs.pdf

As already stated, the actual reference is Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies) of the Fortieth Report (WHO Technical Report Series No. 937)' (PDF pages 451-473, printed report pages 439-461).

In your previous post you mentioned FDA's 'format of the SOPs'. Do you have a link handy?

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Complete thread:

Required SOPs for BA BE unit by all regulatory requirement Dr.Pravin 2006-11-13 06:55
- Required SOPs for BA BE unit by the WHO Helmut 2006-11-13 11:27
  - Required SOPs for BA BE unit by the WHO sekhar91 2006-11-22 12:44
    - Required SOPs for BA BE unit by the FDA? Helmut 2006-11-22 13:06
- Required SOPs for BA BE unit by the WHO sekhar91 2006-12-22 11:04
  - Required SOPs for BA BE unit by the FDA?Helmut 2006-12-22 12:30
    - Required SOPs Clinical Trials! Sumanta Goswami 2007-01-16 17:25
      - Required SOPs Clinical Trials! venu 2007-02-16 08:04