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Shastris ☆ 2010-04-14 08:13 (5922 d 09:13 ago) Posting: # 5112 Views: 3,199 |
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Dear all, In multiple analyte projects, how are the samples selected for ISR for each analyte? Would appreciate suggestions on the same Regards, Shastri |
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vajra123 ☆ India, 2010-04-14 08:21 (5922 d 09:05 ago) @ Shastris Posting: # 5114 Views: 2,660 |
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Dear Shastris, Even in case of multianalyte, individual analyte will be coniserded for the acceptance. So in the selection of the ISR samples both the analytes has to be selected. For Example: If study containes Irbesartan and Hydrochlorothiazide, for the both the Cmax values and Tmax will different. So for irbesartan selected samples which are near by the Cmax and for Hydrochlorothiazide Viceversa. below is the link which may be useful. http://www.ema.europa.eu/pdfs/human/ewp/19221709en.pdf Regards, Vajra123 — Vajra |
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Shastris ☆ 2010-04-14 17:21 (5922 d 00:04 ago) @ vajra123 Posting: # 5134 Views: 2,601 |
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Dear Vajra, Thank you for the response. I was actually looking at a situation where in analyte and metabolite/s OR 2 or more than 2 analytes are quantified simultaneously. (Difference in Tmax may or may not be less than an hour) In such instances how will the samples be selected for each analyte/metabolite/s? Also as per the white paper, samples need to be selected for each analyte. If the samples are picked for each analyte, then do we look at the data for the other analyte (analyte 2) from this set also OR do we stick to ISR results from the samples actually picked for Analyte 2? E.g: Simultaneous analysis of Stavudine and Lamivudine Samples picked for Stavudine. ISR passes. Lamivudine results from this set of samples also to be looked into? What if it fails? Samples picked for lamivudine. ISR passes. Stavudine results from this set of data also to be looked into? What if it fails? Request comments on the same Regards, Shastri |
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vajra123 ☆ India, 2010-04-15 07:07 (5921 d 10:19 ago) @ Shastris Posting: # 5145 Views: 2,604 |
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Dear Shastris, As I told you earlier the selection of the samples entirely depends on the in house specifications. For example you can select the 2 or 3 time points at the Cmax from each period. As the ISR will be performed for the method reproducubility. so when there is a simultaneous method like as you said Stavudine and Lamivudine eventhough we select the samples for the Stavudine ISR and the data of the lamivudine will also be looked for the acceptance. If the Method is quantifying 2 or more than each analyte ISR has to be done, If protocol,defines all the three analytes to be estimated. Then for all the analytes ISR has to be performed. If the data of lamvudine fails  when your doing the Stavudine ISR or viceversa question will be raised from the regualotres  .I like to share my personel experience. once we had a FDA in our facility. Method is simultatneous. The auditor has asked for the comparsion of the data from the passed one to the failed one.(for example if stavudine fails in the batch and it is repeated, the repeated results are compared to the failed batch). I hope you got the information which you needed. If am wrong please correct me. Regards,  — Vajra |
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Shastris ☆ 2010-04-16 12:06 (5920 d 05:20 ago) @ vajra123 Posting: # 5151 Views: 2,563 |
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Dear Vajra, Thank you for the detailed response Regards, Shastri |
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