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RegisterISR [Regulatives / Guidelines]
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
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
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Vajra
Vajra
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