Bioequivalence and Bioavailability Forum

MR formulation food effect [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2012-09-18 21:48 (5030 d 03:29 ago) – Posting: # 9238
Views: 3,861

Hi Dan!

❝ The originator has two MR formulations (A and B; same strength of xxx) on the market. For A the SmPC states no food effect, for formulation B a significant food effect was demonstrated.

Funny. If I could put regulator’s boots on I would politely suggest the innovator to take formulation B off the market.

❝ We aim for formulation A …

Reasonable.

❝ … and I would like to avoid the single-dose fasted study.

Hhm.

❝ Does Appendix 1 of guideline CPMP/EWP/280/96 Corr * refer to the formulations or to the drug entities itself?

IMHO the former. I would suggest to be a little patient until part II of the new MR draft is published (announced for the end of this month). Maybe we see some enlightening stuff (SD/MD, fasting/fed, etc).

---

P.S.: For part I see here.

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


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Science Quotes

Complete thread:

• MR formulation food effect Dr_Dan 2012-09-18 16:10 
  • MR formulation food effectHelmut 2012-09-18 19:48
    • MR draft: not this month Ohlbe 2012-09-25 18:32
      • MR draft: not this month Helmut 2012-09-25 20:17
        • MR draft: not this month The Outlaw Torn 2013-01-17 13:38
          • MR draft: this year? Helmut 2013-01-17 15:08
            • MR draft: this year? The Outlaw Torn 2013-01-18 08:01
              • MR draft: this year? Ohlbe 2013-01-25 18:58
                • 4.54 billion years.... ElMaestro 2013-01-25 20:01