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Ravi ★ India, 2008-06-13 15:27 (6568 d 12:23 ago) Posting: # 1944 Views: 4,084 |
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Dear all, Can any one explain about the purpose of calculating ratio of AUCt to AUCinf during PK Analysis. What is the criteria given in any of the regularity guidlines (USFDA, EMEA). Thanks in advance Regards Ravi — Thanks & Regards Ravi Pandey |
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Jaime_R ★★ Barcelona, 2008-06-13 17:14 (6568 d 10:36 ago) @ Ravi Posting: # 1945 Views: 3,260 |
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Dear Ravi! ❝ What is the criteria given in any of the regularity guidlines (USFDA, EMEA). Please do your homework first: FDA, EMEA. BTW, for IR formulations any sampling after 72 hours most likely will be dropped in the next revision of the European guidline in accordance with the WHO: 'It is currently not foreseen that there would be a need for blood samples to be collected for more than 72 hours.' — Regards, Jaime |
Ing. Helmut Schütz