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Mahesh M ★ India, 2015-01-22 14:55 (4173 d 03:56 ago) Posting: # 14312 Views: 3,679 |
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Dear All, My concern is regarding narrow therapeutic Drug for US FDA submission, FDA release draft product specific guidance for Tacrolimus, phenytoin, warfarin, Levothyroxin and in all recommendation is fully replicated design but serolimus draft guidance recommended two way study design? What is the best option? Is go with draft guidance? Or go with fully replicated design as warfarin? Regards |
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Mahesh M ★ India, 2015-01-27 14:53 (4168 d 03:58 ago) @ Mahesh M Posting: # 14320 Views: 2,764 |
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Requesting to all, Please share your thoughts on above post and suggest study design for Sirolimus ? Regards |
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Helmut ★★★   Vienna, Austria, 2015-01-27 16:46 (4168 d 02:04 ago) @ Mahesh M Posting: # 14321 Views: 2,751 |
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Hi Mahesh, see the Forum’s Policy. Five days ≠ two weeks. What are your thoughts about the NTID-status of sirolimus? Pros, cons,  You asked that question already last year. Read my answer.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz