EMA: Waiving MD study [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-09-09 17:43 (653 d 23:05 ago) – Posting: # 21913
Views: 2,544

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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