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I have no experience with CAR and ELISA assay forced degradation. Available guidance, such as the Brazilian ANVISA, Guideline No. 04/2015 focus on che...

I do not have specific information, but I have heared that Pfizer and GSK filed MODRs.   Join Dr. Joachim Ermer (Ermer Quality Consulting) to...

Yes, that's perfectly true. The initial validation should be regarded as a starting point, i.e. the formal approval of the analytical procedure for pr...

The guideline does not go into details. Of course, you have to take the samples and ranges available or accessible. Whether or not to extrapolate by c...

In principle, this is a prediction interval, but it's referred in the statistical literature as beta-expectation tolerance intervals, in opposition to...

CI are required for validation submission. Once you can compute them, there is no reason to not always report them, even if only for information. The ...

I would always make a risk assessment and identify the method type (impurity, quantitative, etc.) to ensure the relevant parameters are computed. &n...

It's possible to compute the intermediate precision (IP) or total analytical error (TAE) for a reportable value computed from replicates. Hence, if on...

The equivalence test TOTS is included in minitab from version 17. Join Dr Francisca Galindo Garre from Johnson & Johnson Innovative Medicine...

The criterium 3 SD is commonly used for Bland-Altman plot. Note that this criterion should include 99.99% of differences. It is also important to chec...

To set equivalence limits we should take into account which differences are scientifically relevant and also the variation of the methods that we are ...

Generally, I think it is essential to distinguish a method bridging from an instrument change. For method bridging (moving from one analytical method ...

The interest by manufacturers to support users is very well appreciated. I think first of all an active exchange is beneficial in all cases. Generally...

ICH Q2R2 chapter 2.2 offers three scenarios that depend on the degree of performance differences between the two instruments. In case the readout is c...

The use of EC, or rather avoiding that the ECs are not too extensive, is not related to the modality, I think, but rather the amount of knowledge. It ...