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

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

posted by sekhar91 – 2006-12-22 12:04 (7117 d 09:44 ago) – Posting: # 415
Views: 15,588

dear Dr.Pravin,
WHO mentioned some SOPs list which required by CROs to conduct the studies.
I think it may useful to u to get some idea.
http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS05_120Rev1_CROs.pdf

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 WHOsekhar91 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

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