EMA HVD/HVDPs [Design Issues]

posted by ElMaestro  – Denmark, 2015-08-16 21:00 (3466 d 03:59 ago) – Posting: # 15274
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Hi Hötzi,

what they really meant was:

4.1.10 Highly variable drugs or drug products
If an applicant thinks there is a realistic risk that rate of absorprion is associated with an intra-subject CV above 30%, regulators may forgive an applicant for using a replicate design for prospective scaling purposes. The regulators will at all times, however, reserve the right to send deficiency letters remarking on any other aspect of trial design, conduct and results, and may depending on their mood on the day use abusive, humiliating and degrading language towards the applicant.

Pass or fail!
ElMaestro

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