Compliance
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India,
2014-04-23 18:35
(3627 d 01:05 ago)

Posting: # 12877
Views: 1,566
 

 Strength to be evaluated for Canada submssion [Regulatives / Guidelines]

Dear All,

I gone through the both guidance of the Canada to find out on which strength the BE study should be performed. But i could not get any idea however there is clarity found about the strength to be use if drug does not follows linear kinetic.

Kindly advice, is it acceptable if i conduct study on highest strength for a drug which follows linear kinetic? or kindly suggest me any reference in which i can get such information.

Regards,

Compliance
Helmut
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Vienna, Austria,
2014-04-24 08:20
(3626 d 11:20 ago)

@ Compliance
Posting: # 12878
Views: 1,319
 

 Strength to be evaluated for Canada submssion

Hi Compliance,

❝ I gone through the both guidance of the Canada […] But i could not get any idea however there is clarity found about the strength to be use if drug does not follows linear kinetic.


No? What about Section 2.1.1.3?

❝ […] is it acceptable if i conduct study on highest strength for a drug which follows linear kinetic?


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Compliance
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India,
2014-04-24 10:19
(3626 d 09:21 ago)

@ Helmut
Posting: # 12881
Views: 1,186
 

 Strength to be evaluated for Canada submssion

Hi Helmut,

Thanks for your help. I got the reference from the suggested guideline.

Regards,

Compliance
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