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Sathya ☆ India, 2008-08-29 12:57 (6159 d 01:07 ago) Posting: # 2276 Views: 8,688 |
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Hai All, I want to know is Compartmental Analysis and Non compartmental analysis included in Ba/BE studies. how the data will look like for these analysis? — Sathya |
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Ohlbe ★★★ France, 2008-08-29 13:37 (6159 d 00:27 ago) @ Sathya Posting: # 2278 Views: 7,194 |
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Dear Sathya, No modelling in BE trials ! You will only used non-compartmental analysis there. Current EMEA guideline: The exclusive use of compartmental based estimates are not recommended. Draft EMEA guideline: The use of compartmental methods for the estimation of parameters is not acceptable. Check other guidelines for the recommendations of the country where you intend to submit your data. I have little experience with BA studies, I'm afraid I can't help you there. Regards Ohlbe |
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Sathya ☆ India, 2008-08-30 06:22 (6158 d 07:42 ago) @ Ohlbe Posting: # 2282 Views: 7,060 |
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Dear Ohlbe, Thank you for your reply. I am very new person to this one. I want some clarification. Where we can use Compartmental analysis? — Sathya |
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Ohlbe ★★★ France, 2008-09-01 00:48 (6156 d 13:16 ago) @ Sathya Posting: # 2288 Views: 7,037 |
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Dear Sathya, ❝ Where we can use Compartmental analysis? For BE trials: not for EU, and as far as I know not for US markets. I don't know about other countries. Regards Ohlbe |
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Sathya ☆ India, 2008-09-01 08:11 (6156 d 05:53 ago) @ Ohlbe Posting: # 2289 Views: 7,017 |
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Hai ohlbe, Thank you for your response. — Sathya |
Ing. Helmut Schütz