Regulators view of HVD drugs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-05-16 17:01 (2498 d 19:38 ago) – Posting: # 17358
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Hi David,

❝ 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?


Is the high variability enough to trigger an inspection? Likely. See Section 2 of the EMA’s CMDh Guidance on triggers for inspections of bioequivalence trials: Quick scan.Can an inspection reveal bad study conduct increasing the variability? Possibly not.
Regulators should assess studies based on the “whole body of evidence”. Would an assessor have the guts to reject an application without relevant findings in an inspection and risk to be overruled by the CHMP in a referral? Duno.

❝ Ideally, regulators would publish in their product-specific guidelines which compounds could be considered "highly variable"...


True. Takes a while. As of today there are only 36 (adopted + draft). Reference-scaling recommended for capecitabine, levodopa/carbidopa/entacapone, posaconazole. In all other cases applicants are left out in the rain with this footnote:IMHO, this is a vicious circle

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