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RegisterPK model [Regulatives / Guidelines]
Hi Helmut!
I can be wrong.
I suppose when we have modified release dosage form there are can be some changes in the PK model. We shold take in to accaunt that dissolution profile of form in GI can have own dynamic. For example: if absorbtion of dissoluted drug is high and dissolution is linear we can have something with "plato" profile. So resulting PK profile can be wery surprising.
I can be wrong.
I suppose when we have modified release dosage form there are can be some changes in the PK model. We shold take in to accaunt that dissolution profile of form in GI can have own dynamic. For example: if absorbtion of dissoluted drug is high and dissolution is linear we can have something with "plato" profile. So resulting PK profile can be wery surprising.
Complete thread:
- EMA: Waiving MD study Helmut 2020-09-09 16:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Waiving MD study wienui 2020-09-09 17:43
- EMA: Waiving MD study Helmut 2020-09-09 19:26
- PK modelPharmCat 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
- Zero order helps often PharmCat 2020-09-11 02:33
- Zero order helps often Helmut 2020-09-10 22:26
- EMA: Waiving MD study wienui 2020-09-09 17:43
Ing. Helmut Schütz