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RegisterAnalytical issues in combinations Tablets [Bioanalytics]
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
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
Complete thread:
- Analytical issues in combinations Tablets Imran 2007-11-03 08:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Analytical issues in combinations TabletsOhlbe 2007-11-04 00:22
Ing. Helmut Schütz