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

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Biopharmaceutics Classification System (BCS) Permeability Low High High Class 1 High solubility (HS) High permeability (HP) Class 3 Solubility High solubility (HS) Low permeability (LP) Low Class 2 Low solubility (LS) High permeability (HP) Class 4 Low solubility (LS) Low permeability (LP) HS : Highest dose is soluble in
Rate limiting step in gastrointestinal (GI) absorption BCS GI absorption IVIVC Class 1 Gastric emptying-limited Not expected (HS / HP) if dissolution is rapid Class 2 Dissolution-limited Expected (LS / HP) Class 3 (HS / LP) Class 4 (LS / LP) Permeability-limited Not expected Dissolution or ? permeability-limited IVIVC : in vitro/in vivo correlation
Page 1 and 2: Harmonization, Globalization and In
Page 3 and 4: Flufenamic acid capsule Kaniwa, Int
Page 5: Unreliable in vitro/in vivo correla
Page 10 and 11: Cinnarizine capsules Ogata, Int.J.P
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