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venkatmph ☆ 2008-01-10 14:03 (6745 d 18:20 ago) Posting: # 1496 Views: 3,910 |
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Dear sir, is there any condition that can change the BE limits (80-125%) pratap |
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Helmut ★★★   Vienna, Austria, 2008-01-10 14:22 (6745 d 18:01 ago) @ venkatmph Posting: # 1498 Views: 3,132 |
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Dear Pratap! ❝ is there any condition that can change the BE limits (80-125%) High variability (+ high therapeutic index)... See one of my lectures... — 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 |
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Rajdeep ★ New Delhi, India, 2008-01-14 08:44 (6741 d 23:39 ago) @ venkatmph Posting: # 1514 Views: 3,092 |
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Hi there There are regulations for ranges that differ from country to country. Mostly everyone has channelised the range to be 80-125% for normal drugs as per USFDA, but yes HVDs tend to have a different range in which it has to be analysed. It can be found in all the guidelines. -- Edit: Full quote removed. Please see this post! [HS] — Best regards Rajdeep Mukherjee Protocol Developer |
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ShankarCL ● 2008-02-29 13:40 (6695 d 18:43 ago) @ venkatmph Posting: # 1649 Views: 2,833 |
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Dear Pratap, Please look at the Q&A document of the EMEA guidelines for the answer. Shankar |
Ing. Helmut Schütz