Mithu
★    

India,
2022-09-01 08:55
(981 d 05:00 ago)

Posting: # 23246
Views: 3,093
 

 Application of 90% CI for Ctau [Regulatives / Guidelines]

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Dear All,

Hope all are doing good.

My question is, in steady state studies, does 90% CI is mandatory to apply for Ctau? I believe it is secondary parameter and requires to submit as supportive Pharmacokinetic.

please guide me in this regard.

Regards,

Mithu

Edit: Category changed; see also this post #1. [Helmut]
 
Helmut
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Vienna, Austria,
2022-09-01 18:40
(980 d 19:14 ago)

@ Mithu
Posting: # 23257
Views: 2,437
 

 Do your homework first

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Hi Mithu,

❝ My question is, in steady state studies, does 90% CI is mandatory to apply for Ctau? I believe it is secondary parameter and requires to submit as supportive Pharmacokinetic.


Do you see the tab Guidelines on top of the page?

For the EMA see the current guideline Section 6.8.2. AFAIK, not required for the FDA.
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