Bioequivalence and Bioavailability Forum • EMA Guideline on Bioanalytical Method Validation

EMA Guideline on Bioanalytical Method Validation [Regulatives / Guidelines]

posted by sevim – 2011-09-19 11:04 (5399 d 04:49 ago) – Posting: # 7369
Views: 3,450

Dear all,

I have some questions about the new guideline and I will be very appreciated if you can help me.

In the chapter of Method Validation- Calibration Curve (page 6), it is written that "Each calibration standard can be analysed in replicate." Based on this sentence, the criteria for the acceptance of the calibration curve changes. By the way, if one of the calibration standards(except LOQ and ULOQ) does not comply the criteria I can omit it. What about if the other value of the same calibration standard also does not comply the criteria, do you think that I can also reject this value? And how many times can I apply this process? (There are eight calibration standards). I need at least six valid calibration standards, so I understand that I can reject two of the invalid calibration standards from the curve. Will the batch be valid, if only one of
the LOQ or ULOQ values are in the range or should both of the data be in the range?
How can be the sequence of this replicate calibration standards? Should the same calibration standards be applied successively or can they be analysed separately in the batch?
If the replicates of the calibration standard comply the criteria, should I take the average of these two values and draw the calibration curve according to this average values?

Thanks for your interest and informing.
Best Regards,
Sevim.

EMA Guideline on Bioanalytical Method Validationsevim 2011-09-19 09:04
- EMA Guideline on Bioanalytical Method Validation Ohlbe 2011-09-19 20:33