Highly variable NTID [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2015-09-23 10:23 (3433 d 01:31 ago) – Posting: # 15454
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Dear Helmut,

❝ ❝ I had interpreted the sentence "Dabigatran demonstrated a steep exposure response relationship for both efficacy and safety." as some sort of NTID.


❝ Me too. Seems that the innovator (Boehringer Ingelheim) assessed the variabilities in its studies.

❝ This is the first example I’m aware of were the observation “HVDs/HVDPs are safe drugs since they have a flat dose/response-curve” seemingly does not hold.


Oh I see. That's the reason for the sentence "Therefore applicants should not use the reference-scaled average bioequivalence (BE) approach to widen the BE limits for dabigatran BE evaluation" in the dabigatran guidance.

Seems it's time for a new term: HVNTID :cool:

❝ A dirty story? Wikipedia ...


A really dirty story :vomit:. So much to "To cheat is Indian" (My exculpation to the Indian members of this forum).

Regards,

Detlew

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