Helmut
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Vienna, Austria,
2010-08-03 18:38
(5800 d 18:33 ago)

Posting: # 5711
Views: 10,771
 

 EMA: Questions & Answers [BE/BA News]

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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
  • Bioequivalence studies for paroxetine (single dose versus multiple dose studies) and
  • Interpretation of bioequivalence data in relation to both parent and metabolite PK data
were deleted, since they are covered in the new BE-GL.

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
or added, namely
  • Acceptance criteria for bioequivalence studies for losartan
  • Bioequivalence assessment of generics for tacrolimus
  • Requirements for demonstration of bioequivalence for ciclosporine generics
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Jaime_R
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Barcelona,
2010-08-03 19:03
(5800 d 18:07 ago)

@ Helmut
Posting: # 5712
Views: 8,765
 

 Acceptance ranges

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Dear Helmut and all,

interesting; now we have the first official statement about some NTIDs!
  • Tacrolimus: 90%-111% for AUC and 80%-125% for Cmax
  • Ciclosporine: 90%-111% for AUC and Cmax (fasting and fed)
Also a clear statement, where widening for Cmax is not acceptable (Clopidogrel, Losartan).
—
Regards, Jaime
 
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