Fabiola Carrara

3 Questions 2 Answers 0 Followers

Questions related from Fabiola Carrara

Acceptability Criteria for Precision and Accuracy According to ICH Q2(R1)?

According to the ICH Q2(R1) guidelines, the acceptability criteria for precision and accuracy are critical in evaluating the performance of analytical methods. These criteria differ for analytical...

13 December 2024 4,265 3 View

Which parameters should be evaluated to perform the Partial Validation of a chromatographic method already validated?

I have fully validated an analytical method in HPLC and now following the purchase of a new instrument (same brand new model) I will have to do the partial validation. Unfortunately, EMA does not...

08 September 2021 1,733 3 View

Does anybody have experience in method validation of endogenous compound according to FDA's GLP bioanalytical method validation guidance?

I need to validate a method that determines compound X in human plasma. However, this compound is endogenous to plasma and is present in a wide range of concentrations between "blank" plasma lots....

22 October 2018 6,462 3 View