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Imran ☆ Mumbai, 2007-11-03 09:02 (6806 d 01:13 ago) Posting: # 1270 Views: 4,645 |
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Dear HS and PK Friends Please suggest In a BE study of combination tablet A+B, if drug 'A' and drug 'B' has a half life of 2 hrs and 15 hours respectively. Considering sampling upto 5 half life sampling for drug 'A' will be up to 12 hrs and that of drug 'B' will be up to 75 hrs to capture at least 80% AUC. My question is ' if I analysed drug 'A' only upto 12 hrs and drug 'B'upto 75 hrs to save the analysis of drug 'A' which own be of any use for analysing upto 75 hrs, will it be acceptable from regulatory point of view. best regards, — Dr.Imran Khan |
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Ohlbe ★★★ France, 2007-11-04 01:22 (6805 d 08:52 ago) @ Imran Posting: # 1274 Views: 3,518 |
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Dear Imran, I assume you would be using separate methods for drugs 'A' and 'B' (no or very little cost difference otherwise). IMHO it would make no regulatory difference to have a table of results for drug 'A' stopping at 12 hours, or to have a table up to 75 hours (last point for drug 'B') but with all values after 12 hours reported as 'BLQ'... But make sure you are on the safe side when deciding for the last time point you will use for your drug 'A' (which should be specified in the protocol). You would be in trouble if you stopped at 12 hours and then have more than 20 % extrapolation. Difficult to explain and justify then. Regards Ohlbe |
Ing. Helmut Schütz