Bioequivalence and Bioavailability Forum

Ask the applicant [Design Issues]

posted by Helmut  – Vienna, Austria, 2016-05-31 16:07 (3677 d 06:34 ago) – Posting: # 16375
Views: 6,101

Hi Mahesh,

❝ As per PIL “You should take Glucophage SR with or immediately after food.” But applicant performed multiple dose study under fasting condition not under fed condition?

Wockhardt Ltd.
Wockhardt Towers
Bandra Kurla Complex, Bandra (East)
Mumbai 400051
Maharashtra, India
T: +91 22 2653 4444
F: +91 22 2652 3905
E: [email protected]
(SCNR)

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


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Complete thread:

• multiple dose study Mahesh M 2016-05-30 09:42 
  • 1999 Note for Guidance? Helmut 2016-05-30 13:37
    • 1999 Note for Guidance? Mahesh M 2016-05-31 13:50
      • Ask the applicantHelmut 2016-05-31 14:07
        • Ask the applicant Mahesh M 2016-06-01 08:45