Bioequivalence and Bioavailability Forum • Common sense…

Common sense… [Design Issues]

posted by Helmut – Vienna, Austria, 2012-06-15 19:50 (5127 d 00:47 ago) – Posting: # 8746
Views: 6,359

Dear Pradeep!

Please follow common sense. If you dose at 07:00 and 19:00 and follow the -8h/+4h fasting restriction per dose you would end up with the last meal 23:00 before administration and the first one 23:00 on the profile day. Have never seen such a study. The -8h restriction is not applicable to the second dose; the +4h restriction is at least debatable.

BTW, you were referring to the IR GL (2010); the MR NfG (1999) does not contain such a statement at all.

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

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Complete thread:

Restrictions for steady state study europe achintparikh 2012-06-15 08:23
- Common sense…Helmut 2012-06-15 17:50
  - Reference achintparikh 2012-06-16 06:42
    - Reference drgunasakaran1 2012-06-16 07:25
- Restrictions for steady state study europe Chiku 2012-06-18 12:09
  - Fed+fasting (SD), MD, draft MR GL expected QIII/2012 Helmut 2012-06-18 13:01
    - Fed+fasting (SD), MD, draft MR GL expected QIII/2012 Chiku 2012-06-19 05:45