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Compliance ★ India, 2012-07-11 08:39 (5102 d 21:08 ago) Posting: # 8923 Views: 3,285 |
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Dear All, Kindly let me know under what circumstances we can increases the dose volume? My drug is measured with the less amount of doses (5 ml) under fasting condition but during fed, few of the subject concentration comes BLQ. Due to this we have decided to increases the dose twice. Is the dose increases due to this reason is acceptable? I don’t feel (might be not correct) this is a sensitivity issue related to bioanalytical. I feel this is a issue related to formulation. Kindly correct my understanding. Awaiting for your reply for my better understanding. Regards, Compliance |
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hiren379 ★ India, 2012-07-11 13:23 (5102 d 16:24 ago) @ Compliance Posting: # 8926 Views: 2,579 |
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❝ Kindly let me know under what circumstances we can increases the dose volume? My drug is measured with the less amount of doses (5 ml) First of all my good friend, dose when given in mL always comes with the concentration of the dosage form. But concidering that same concentration is used for both fast and fed read my below responce. ❝ under fasting condition but during fed, few of the subject concentration comes BLQ. Why only few...Is the drug highly variable? ❝ Due to this we have decided to increases the dose twice. I think you need to check the following 1) If the drug is not reaching saturation kinetics by increasing the dose 2) Ethics committe agrees to high dose 3) You have enough justification why yr LLOQ is low. 4) No recomendations given by OGD (If you are talking for USFDA) If yr concern is that regulatory will shout at you, then stay cool if above criteria are met. |
Ing. Helmut Schütz