Dr.Sridhar
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2007-10-25 08:10
(6819 d 08:23 ago)

Posting: # 1252
Views: 3,816
 

 Study design - Drugs with Long half life [Design Issues]

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Dear all,
Why usually
1. sponsors for BE study (drugs with long half life) do not prefer for parallel design, they prefer cross over design.
2. And also sponsors do not prefer truncated study for long half life drugs.

But above are the prefect indications for parallel and truncated study.

regards,
Dr.Sridhar
 
Helmut
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2007-11-02 19:00
(6810 d 20:33 ago)

@ Dr.Sridhar
Posting: # 1268
Views: 3,018
 

 Study design - Drugs with Long half life

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Dear Sridhar,

I agree with you to 100%...

Maybe you should hand out the WHO-Guideline to your sponsors (advising them to read Sections 6.2.2, 6.6.2, and especially 6.11.4). :-D
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