Compliance ★ India, 2014-04-23 18:35 (3627 d 01:05 ago) Posting: # 12877 Views: 1,566 |
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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 ★★★ Vienna, Austria, 2014-04-24 08:20 (3626 d 11:20 ago) @ Compliance Posting: # 12878 Views: 1,319 |
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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? Bioequivalence of Proportional Formulations: Solid Oral Dosage — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Compliance ★ India, 2014-04-24 10:19 (3626 d 09:21 ago) @ Helmut Posting: # 12881 Views: 1,186 |
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Hi Helmut, Thanks for your help. I got the reference from the suggested guideline. Regards, Compliance |