EMA: Waiving MD study [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-09-09 19:43 (1315 d 08:15 ago) – Posting: # 21913
Views: 2,959

Hi Helmut,

❝ at the end an [image] script to play with.


❝ For any elimination half life of > 7 hours and an intended dosing interval of 24 hours it will be impossible to get the MD study waived. Red are formulations with flip-flop PK (kakel).


Could you please kindly add more explanation.

Cheers,
Osama

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