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Study Design with long half life [Design Issues]

posted by Pankaj – India, 2010-03-21 17:30 (5939 d 16:11 ago) – Posting: # 4950
Views: 4,543

Dear All,

Planning to design a BABE protocol on a molecule with Tmax around 1-1.5 hours and T-half of around 550 hours.
Can we go for parallel truncated design for the molecule? Does all the regulatories (US/EU/ANVISA) accept such kind of design for BABE studies?
Kindly Suggest.

Thanks in advance.

Regards,

Pankaj

Complete thread:

Study Design with long half lifePankaj 2010-03-21 16:30
- Truncated AUC (once again) Helmut 2010-03-22 06:33
  - Truncated AUC (once again) Pankaj 2010-03-22 07:17
    - Truncated AUC (once again) Helmut 2010-03-22 14:43

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