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If you were to change critical reagent lots for a validated ADA assay (with no other changes to the method), what are the assessments that are generally included in the partial validation? What are the criteria that would decide whether or not a re-do ...

​Kevin: It is a 2-way traffic. that is, gaining knowledge by reading the posts and sharing back with the Community what we know. It is important to all engage in the discussion in pursuit of better understanding the science and finding the solutions to ...

​ Simply put, we perform a Data Integrity (DI) risk assessment on each instrument. How is the data handled? Where is it going to / from? How is it used? Who can access? What controls are in place (electronic and procedural)? What are the data integrity ...

I think for new instruments and modalities, it is definitely a case-by-case basis, but at the minimum a set of guideline questions to ask for each one would be helpful - the ones from Scott's last comment in this thread is a good start.  There will always ...

The links below provide some suggestions in this regard. I hope people will find these useful. http://www.drug-dissolution-testing.com/?p=2364 http://www.drug-dissolution-testing.com/?p=2369 http://www.drug-dissolution-testing.com/?p=3065 ...

The link below provides a different view which should be considered before making any further claims about BE studies/assessments. Thanks. http://www.drug-dissolution-testing.com/?p=3065 ------------------------------ Saeed Qureshi [Principal] ...