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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...

"The dossier holder (client) is responsible for the specifications, even if the product is manufactured by a CRO. The CRO may propose or assist in dev...

"Planification is or should always be possible even for biological products this means that planning for doing DoEs to define NOR and PAR is available...

"I think in general, one could always overthink ECs. Nonetheless, in earlier phases with little prior knowledge, effort is needed to set up ECs. It is...