Bioequivalence and Bioavailability Forum • EMA: Waiving MD study

EMA: Waiving MD study [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2020-09-09 19:43 (1588 d 07:48 ago) – Posting: # 21913
Views: 4,024

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 (k_a ≤ k_el).

Could you please kindly add more explanation.

—
Cheers,
Osama

Complete thread:

EMA: Waiving MD study Helmut 2020-09-09 16:21 [Regulatives / Guidelines]
- EMA: Waiving MD studywienui 2020-09-09 17:43
  - EMA: Waiving MD study Helmut 2020-09-09 19:26
- PK model PharmCat 2020-09-10 20:12
  - Zero order helps often Helmut 2020-09-10 22:26
    - Zero order helps often PharmCat 2020-09-11 02:33
      - Distributed delay mittyri 2020-09-11 05:31