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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...

Yes, I think that the enhanced approach is an incentive to use software-assisted method development. Pieces of software are already used to automate, ...

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 heard that Pfizer and GSK filed MODRs. Join Dr. Joachim Ermer from Ermer Quality Consulting to le...

Re: ICH Q2 revision 2 - Yes, thats perfectly true. The initial validation should be regarded as a starting point, i.e. the formal approval of the anal...

When only a small number of batches are available, a purely statistical approach cannot be relied upon. Prior knowledge, including data from early dev...

Definitely, I would challenge the analytical development team as well as the process team to gather all prior information available from development s...

If the drug product (DP) testing scheme is intended for the European market and only Ph. Eur. chapters have been verified, and you wish to apply it to...

The guideline does not go into details. Of course, you must take into account the samples and ranges that are available or accessible. Whether or not ...

"This would be of great help for sure, better knowing and modelling the relationship between structure and function and above all the predictive impac...

"Yes, understanding the structure–function relationship of heterogeneous biomolecules is essential for setting patient-centric specifications. It help...