Bioequivalence and Bioavailability Forum • Progesterone Bioequivalence trial

Progesterone Bioequivalence trial [Power / Sample Size]

posted by ashutoshkumaryadav – Ahmedabad, India, 2007-12-06 13:58 (6772 d 02:09 ago) – Posting: # 1359
Views: 11,085

Dear MGR,

Thanks for your kind reply.
You are right we can reduce the sample size by opting 4way crossover design. Conducting a BE study with 100 subject is not an issue. we can go ahead with 100 sample size but for this we need a proper justification. I have gone through a presentation in which 98% ISCV is mentioned, in that case approximately 300 sample size is required. I am not getting any published article for the exact ISCV of progesteron.
Do you have any reference for Progesteron ISCV.

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Edit: Full quote removed. Please see this post! [HS]

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Thanks and regards
Ashutosh Kumar Yadav
M.Pharm (Pharmacology)
Mob. No. +91-079-9904516032

Complete thread:

Progesterone Bioequivalence trial ashutoshkumaryadav 2007-10-10 15:03
- Progesterone Bioequivalence trial MGR 2007-12-04 06:40
  - Progesterone Bioequivalence trialashutoshkumaryadav 2007-12-06 12:58
    - Progesterone Bioequivalence trial MGR 2007-12-07 06:19
      - Progesterone Bioequivalence trial drshiv 2007-12-12 09:43
        
        Progesterone Bioequivalence trial ashutoshkumaryadav 2007-12-13 10:12