Last seen: Jul 14, 2026
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 ...
The cornerstone of the whole approach is the ATP. If priority has to be given to a "part", then definitely the ATP. The ATP alone is not enough for th...
Chronologically speaking, the validation is performed first (and it is recommended to include such a control as part of the validation), then the tren...
I fear that we might have a too statistical view of robustness, especially for early phases. Robustness data might be the voice of the customer (does ...
Not currently, but it is our goal for our next filings to better justify that certain CQAs, when controlled by an analytical procedure, are correctly ...
I do not think that MODR (except in exceptional cases) has much added value. As correctly stated in the question, the cost of establishing an MODR req...
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