Bioequivalence and Bioavailability Forum

Helmut
★★★

Vienna, Austria,
2010-08-03 18:38
(5008 d 03:21 ago)

Posting: # 5711
Views: 8,214

EMA: Questions & Answers [BE/BA News]

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

or added, namely

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

Jaime_R ★★ Barcelona, 2010-08-03 19:03 (5008 d 02:55 ago) @ Helmut Posting: # 5712 Views: 6,810	Acceptance ranges Post reply
	Dear Helmut and all, interesting; now we have the first official statement about some NTIDs! Tacrolimus: 90%-111% for AUC and 80%-125% for C_max Ciclosporine: 90%-111% for AUC and C_max (fasting and fed) Also a clear statement, where widening for C_max is not acceptable (Clopidogrel, Losartan). — Regards, Jaime