EMA: Waiving MD study [Regulatives / Guidelines]
❝ at the end an 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 (ka ≤ kel).
Could you please kindly add more explanation.
- EMA: Waiving MD study Helmut 2020-09-09 16:21 [Regulatives / Guidelines]