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

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Use of BCS as a Risk Factor BCS is currently not employed in Japan, which, however, should be used as a risk factor when dissolution test is expanded to “Biowaiver” for major changes in formulation and manufacturing and even for generic products, when the disadvantages of dissolution tests are considered. By the combination use of dissolution test and BCS, significant bio-inequivalence inequivalence problems will be avoided, leading to the reduction of patient’s s risk (Immediate application of dissolution test for all classes of drugs is risky).
Risk Factors to be Considered for Biowaiver Low Risk High BCS Class 1 Class 4 Dosage form Drug release Therapeutic window Diseases Adverse effect Elimination half life Simple IR Wide Nonserious Mild Long Complicated CR Narrow Serious Severe Short
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 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 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