Regulatory Response to BCS in Japan BCS : æ¥æ¬ã«ããã ... - NIHS

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In Vivo : Dynamic In Vitro : Static pH 1.2 - 7.6 Fluid volume 5 - 200 ml pH 3.1- 6.7 Contraction
To predict in vivo performance, dissolution test must be done under various conditions (different pH, ionic strength, agitation etc). Not suitable for BE test Is there simpler approach ? Based on current understanding of GI physiology and learned knowledge, discriminative dissolution tests should be established that are able to discriminate Bioinequivalent products. What is the discriminative dissolution tests ?
Page 1 and 2: Harmonization, Globalization and In
Page 3 and 4: Flufenamic acid capsule Kaniwa, Int
Page 5 and 6: Unreliable in vitro/in vivo correla
Page 7 and 8: Rate limiting step in gastrointesti
Page 10 and 11: Cinnarizine capsules Ogata, Int.J.P
Page 14 and 15: Discriminative dissolution test IR
Page 16 and 17: Paddle, 50 rpm 100 Predicted Level
Page 18 and 19: Different dissolutions under one of
Page 20 and 21: Use of Dissolution Test in BE Asses
Page 22 and 23: Bioavailability Same Bioavailabilit
Page 24 and 25: Reason 1 Solubility and permeabilit
Page 26 and 27: • Strict requirement using specif
Page 28 and 29: Multimedia dissolution tests used i
Page 30 and 31: % dissolved 100 50 0 100 0 20 40 60
Page 32 and 33: Reasons for Not using BCS • Solub
Page 34 and 35: Use of BCS as a Risk Factor BCS is
Page 36 and 37: To use dissolution test for biowaiv

Regulatory Response to BCS in Japan BCS : æ¥æ¬ã«ããã ... - NIHS

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Regulatory Response to BCS in Japan BCS : æ¥æ¬ã«ããã ... - NIHS