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Naren ☆ India, 2016-12-02 13:29 (2701 d 02:19 ago) Posting: # 16826 Views: 3,022 |
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Dear All, As per Guidelines for Bioavailability and Bioequivalence Studies issued by CDSCO-India, intervals between sampling time points used to calculate the terminal elimination rate constant should not be longer than the half life of the study drug. Any reason behind this?? Regards, Naren |
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javier ☆ Spain, 2016-12-02 14:11 (2701 d 01:36 ago) @ Naren Posting: # 16827 Views: 2,587 |
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❝ Dear All, ❝ ❝ As per Guidelines for Bioavailability and Bioequivalence Studies issued by CDSCO-India, intervals between sampling time points used to calculate the terminal elimination rate constant should not be longer than the half life of the study drug. Any reason behind this?? ❝ ❝ Regards, ❝ Naren Hi Naren its a very good question, i think its linked with guidelines recommendation (im speaking by memory) in my opinion its necessary 3 half-lives to calculate the overall pk sampling time because you want to include at least 80% of the AUC, but again, i have to look it in the guidelines (one more task for this friday) Maybe some seniors members can add some experience in this matter best regards Javier |
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Yura ★ Belarus, 2016-12-03 10:49 (2700 d 04:58 ago) @ javier Posting: # 16828 Views: 2,534 |
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Dear All, I use for calculation of elimination coefficient not less than three non-zero meanings of a concentration. Its very interesting for me why "the terminal elimination rate constant should not be longer than the half life of the study drug"? Give me links, please. |
Ing. Helmut Schütz