Regulators view of HVD drugs [Regulatives / Guidelines]

posted by DavidManteigas – Portugal, 2017-05-16 12:41  – Posting: # 17357
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Hi Helmut,

For the sake of curiosity, in your opinion should a regulator approve a generic submited as "highly variable" although all the previous trials reported low CV's? Technically, the criteria are well defined and no objection should be raised in principle. However, should a study that reports an high variation, when all the previous information reports otherwise, be considered scientifically sound for the demonstration of bioequivalence? Ideally, regulators would publish in their product-specific guidelines which compounds could be considered "highly variable"...

Regards,
David

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