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Method Operable Design Region (MODR)

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Posts: 32
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(@event-participant)
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Do you feel MODR is a desired outcome of the analytical procedure development? It requires extensive data generation, advanced processing and reporting, and in many cases the lab is such a controlled setting that the edges of performance are not likely to be so relevant. Is PAR and limited robustness testing at nominal settings not sufficient?

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(@quality-experts)
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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 requires a major investment that, in my opinion, is not relevant, while most of the analytical parameters do not need to be used outside of their target. There might be some exceptions for, eg, (cell) titration methods that require adjustable dilutions. The dilution scheme that is adapted depending on the stock concentration can be covered by an MODR (even if I would tend to cover it by beefing up the intermediate precision experiment).

 

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