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

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Cinnarizine capsules Ogata, Int.J.Pharm. 29, 113, 1986 Concentration (ng/ml) 100 80 60 40 20 Normal subject B C Concentration (ng/ml) 100 80 60 40 20 Achlorhydric subject B C 0 0 2 4 6 8 Time (h) 0 0 2 4 6 8 Time (h) Achlorhydria (%) 80 60 40 20 0 10 20 30 40 50 60 70 Age (year) Achlorhydric subject (%) in each age category Morihara, Biol.Pharm.Bull., 24, 313,2001
• BE test for whom and in whom ? • How to assure BE in normal and achorhydric subjects? Can we require BE tests in both groups? • Is dissolution testing truly of no use for BE assessment ? Need to clarify why in vitro/in vivo correlations are unreliable
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 12 and 13: In Vivo : Dynamic In Vitro : Static
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