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