Bioequivalence and Bioavailability Forum • EMA: Draft product-specific guidance ♬

Helmut
★★★

Vienna, Austria,
2013-12-06 02:54
(4177 d 04:01 ago)

Posting: # 12010
Views: 5,311

EMA: Draft product-specific guidance ♬ [BE/BA News]

Dear all,

after the first 16 guidances EMA keeps going. The complete list with the respective end of consultation here.

Sunitinib published 2013-12-04
50 mg single dose cross-over in healthy subjects (fasting state), parent in plasma (achiral),
AR 80.00–125.00% for AUC₇₂ and C_max (HVD status not reviewed).

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

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