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RegisterEMA: Questions & Answers [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2010-08-03 18:38 (5008 d 13:48 ago) – Posting: # 5711
Views: 8,214
Dear all,
'Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics' were updated on 22 July 2010.
Two issues, namely
Other points were updated
'Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics' were updated on 22 July 2010.
Two issues, namely
- Bioequivalence studies for paroxetine (single dose versus multiple dose studies) and
- Interpretation of bioequivalence data in relation to both parent and metabolite PK data
Other points were updated
- Requirements for food-interaction studies for modified release formulations
- Bioequivalence of gastro-resistant preparations (e.g. omeprazole)
- Bioequivalence studies for generic products containing clopidogrel
- Acceptance criteria for bioequivalence studies for losartan
- Bioequivalence assessment of generics for tacrolimus
- Requirements for demonstration of bioequivalence for ciclosporine generics
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA: Questions & AnswersHelmut 2010-08-03 16:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Acceptance ranges Jaime_R 2010-08-03 17:03
Ing. Helmut Schütz