Method Validation [Bioanalytics]
Dear members,
I have a combination of Drug 1+2+3. Since it is not possible to analyze all three together, I have validated method for drug 1 separately and drug 2and 3 will be validated in combination.
The point here is since subject samples will be in combination of all three, I will be analyzing it twice with two different methods, but the validation is not done in presence of drug1 for drug2 and drug3 and vice versa.
I nedd suggestions as to how to plan an experiment so that it can be proved that the method used for Drug1 does not have any interference of drug 2 and drug3 and vice-versa.
Any reference to guidelines are welcome.
Thanks in advance
Chirag Khatri
I have a combination of Drug 1+2+3. Since it is not possible to analyze all three together, I have validated method for drug 1 separately and drug 2and 3 will be validated in combination.
The point here is since subject samples will be in combination of all three, I will be analyzing it twice with two different methods, but the validation is not done in presence of drug1 for drug2 and drug3 and vice versa.
I nedd suggestions as to how to plan an experiment so that it can be proved that the method used for Drug1 does not have any interference of drug 2 and drug3 and vice-versa.
Any reference to guidelines are welcome.
Thanks in advance
Chirag Khatri
Complete thread:
- Method Validationchiragkhatri 2007-12-14 06:21
- Method Validation Ohlbe 2007-12-15 12:05
- Method Validation chiragkhatri 2007-12-15 12:22
- Metabolites! Helmut 2007-12-15 13:42
- Metabolites! Ohlbe 2007-12-16 13:32
- Metabolites! Helmut 2007-12-16 13:50
- Metabolites! Ohlbe 2007-12-16 13:32
- Method Validation Ohlbe 2007-12-15 12:05
