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BEAZ ★ India, 2008-11-18 10:36 (6428 d 09:03 ago) Posting: # 2705 Views: 4,797 |
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Hai, In a cross overstudy with adequate washout period.we are getting predose concentration, kindly any one clarify what would be the reason for this phenomenon.The analytical team assures that there were no process error and it is due to noise (Back calculation of the area observed ). The sample is predose blank. thanks in advance — Alhas |
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ElMaestro ★★★ Denmark, 2008-11-18 11:02 (6428 d 08:36 ago) @ BEAZ Posting: # 2707 Views: 4,001 |
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Dear Alhas, could you provide a little more info? One one hand you seem to be looking for the reason, but on the other hand your analytical staff seems to have come up with the reason for you. What drug? What period (is it a crossover trial)? Test or ref? How long washout? EM. |
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Ohlbe ★★★ France, 2008-11-18 11:17 (6428 d 08:21 ago) @ ElMaestro Posting: # 2708 Views: 3,959 |
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Dear Alhas, Some additional questions: - how much is your pre-dose concentration, compared to Cmax ? Compared to LLOQ ? - are your bioanalytical people sure it can't be due to carry-over (did they check carry-over during the method validation ?) ? Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2008-11-18 12:02 (6428 d 07:36 ago) @ Ohlbe Posting: # 2711 Views: 4,032 |
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...and what do the anova figures for period and sequence effects look like? EM. |
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BEAZ ★ India, 2008-11-19 14:47 (6427 d 04:51 ago) @ ElMaestro Posting: # 2739 Views: 3,892 |
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❝ ...and what do the anova figures for period and sequence effects look ❝ like? dear Em, it is in analytical phase only, observing the data (LCMS/MS output) only raised the query to get more clarity. thanks and regards — Alhas |
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BEAZ ★ India, 2008-11-19 14:45 (6427 d 04:54 ago) @ Ohlbe Posting: # 2738 Views: 3,894 |
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Dear Ohlbe, thank you ❝ Some additional questions: ❝ - how much is your pre-dose concentration, compared to Cmax ? Compared to ❝ LLOQ ? ❝ - are your bioanalytical people sure it can't be due to carry-over (did ❝ they check carry-over during the method validation ?) ? this i have to confirm and let you know. regards — Alhas |
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BEAZ ★ India, 2008-11-19 14:37 (6427 d 05:01 ago) @ ElMaestro Posting: # 2737 Views: 3,874 |
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Dear EM, Thanks for the response ❝ One one hand you seem to be looking for the reason, but on the other hand ❝ your analytical staff seems to have come up with the reason for you. you are right, but am not satisfied with the response from the analytical team ❝ What drug? What period (is it a crossover trial)? Test or ref? How long ❝ washout? Ethambutol, Cross over, one week washout. -- Edit: Please don't edit within the quoted original post in order to keep the structure intact. [Helmut] — Alhas |
Ing. Helmut Schütz