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Smitha ☆ India, 2018-11-29 12:09 (2121 d 00:59 ago) Posting: # 19656 Views: 3,872 |
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Hello, For BE studies, some of the CRO Bioanalytical Labs select the Cmax time point as the sample for ISR analysis (is also defined in their SOP). The guidelines talk about selection of samples 'around the Cmax'. How appropriate is it to generate another set of data for a critical PK parameter as Cmax? (even if the guidelines indicate that these values should not be used for study conclusion). Would appreciate the members thoughts on this. Thank you. Regards, Smitha |
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Kintan Patel ☆ India, 2018-11-29 12:26 (2121 d 00:43 ago) @ Smitha Posting: # 19658 Views: 3,390 |
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Dear Madam, I do agree with you that it is not appropriate to generate another set of data by selecting ISR sample as Cmax Sample.It is advisable to select ISR sample near to Cmax value not exactly Cmax Value.If your Cmax Value is not within the ISR acceptance or deviating more than 30 % and if it is impacting your study results then it will be very difficult to justify. Thank You. Kintan |
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Ohlbe ★★★ France, 2018-11-29 18:50 (2120 d 18:18 ago) @ Smitha Posting: # 19661 Views: 3,272 |
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Dear Smitha, ❝ How appropriate is it to generate another set of data for a critical PK parameter as Cmax? (even if the guidelines indicate that these values should not be used for study conclusion). I don't see a real problem here: as you say, the guidelines clearly indicate that the ISR value should not be used for the PK/stats. Actually, it sort of helps to avoid some other issues. If you write in your SOP that you will systematically repeat the Cmax sample, there will be no discussion regarding how you selected the samples to be re-analysed and possible bias in sample selection. — Regards Ohlbe |
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jag009 ★★★ NJ, 2018-11-29 19:00 (2120 d 18:09 ago) @ Ohlbe Posting: # 19662 Views: 3,306 |
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❝ I don't see a real problem here: as you say, the guidelines clearly indicate that the ISR value should not be used for the PK/stats. I agree with Ohlbe as well John |
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Smitha ☆ India, 2018-11-30 07:45 (2120 d 05:24 ago) @ jag009 Posting: # 19664 Views: 3,211 |
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Thank you Kintan, Ohlbe and Jag |
Ing. Helmut Schütz