THe BIOWaIVer MONOGraPHS - FIP

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23. http://www.nihs.go.jp/drug/be-guide(e)/form-change2006e.pdf (May 2012) 24. Methodological recommendations for drug manufacturers on in vitro equivalence test for generic drug products according to biowaiver procedure (DRAFT) Federal Service on Surveillance in Healthcare and Social Development, Moscow 2010 http://www.fip.org/files/fip/BPS/BCS/Biowaiver guidance (ru) – ENG March 2011. pdf (May 2012) 25. Benet LZ, Amidon GL, Barends DM, Lennernäs H, Polli JE, Shah VP, Stavchansky SA, Yu LX 2008. The use of BDDCS in Classifying the Permeability of Marketed Drugs. Pharm Res 25:483-488 26. Fagerholm U 2007. Evaluation and suggested improvements of the Biopharmaceutics Classification System (BCS). J Pharm Pharmacol 59:751-757 27. Note for guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Pharmacokinetic and Clinical Evaluation) CPMP/EWP/280/96 http://www.tga.gov.au/pdf/euguide/ewp028096en.pdf (May 2012) 28. Gray VA. Meeting Report: AAPS/FDA Workshop on BE, BCS, and beyond www.dissolutiontech.com/ DTresour/200711Articles/DT200711_A06.pdf (May 2012) 50
Page 3 and 4: Preface For 100 years, the Federati
Page 5 and 6: 1. Amidon GL, Lennernäs H, Shah VP
Page 7 and 8: Table of Contents BIOWaIVer MONOGra
Page 9 and 10: STarTING POINT Of THe PrOJecT - 200
Page 11 and 12: In this way, users of the FIP Biowa
Page 13 and 14: • Risk of approving a test produc
Page 15 and 16: ethambutol III NTI for ocu- lar tox
Page 17 and 18: quinine I-II Dose-related toxicity
Page 19 and 20: Last but not least, there were thre
Page 21 and 22: For chloroquine phosphate, sulfate
Page 23 and 24: Acetaminophen and lamuvidine are bo
Page 25 and 26: is often difficult to pinpoint whet
Page 27 and 28: product has also been tested for sa
Page 29 and 30: FDCs, as well as products containin
Page 31 and 32: levels are set at 90% and the power
Page 34 and 35: uPDaTe ON reGulaTIONS ON in vitro e
Page 36 and 37: Formulation-wise, products designed
Page 38 and 39: Similar to the US-FDA guidance, the
Page 40 and 41: in other cases the dissolution may
Page 42 and 43: Other Jurisdictions Some countries
Page 44 and 45: dissolution are rather briefly ment
Page 46 and 47: Caco-2 permeability on a regular ba
Page 48 and 49: • In several jurisdictions the re
Page 52 and 53: THe BIOWaIVer MONOGraPHS: BcS BaSeD
Page 54 and 55: Regulations in the United States Pu
Page 56 and 57: 1. “high solubility”. The 2005
Page 58 and 59: Apparatus (APP) USP APP I - 100 rpm
Page 60 and 61: IR products that differ in formulat
Page 62 and 63: Quinine Sulfate 1 or 2 61 Ranitidin
Page 64 and 65: 3. Drug C is a substrate of an effl
Page 66 and 67: excipients with information on thei
Page 68 and 69: efereNceS 1. FDA. 2003. Guidance fo
Page 70 and 71: 36. ML Chen, L Yu. 2009. The use of
Page 72 and 73: THe BIOWaIVer MONOGraPHS: THe VISIO
Page 74 and 75: studies in US. The economical benef
Page 76 and 77: Which levels of biowaivers are poss
Page 78 and 79: this phenomenon of a “safe space
Page 80 and 81: Potential future developments of bi
Page 82 and 83: alcohols or PEG 31 . Furthermore, t
Page 84: 17. European Medicines Agency. Comm
Page 87 and 88: INTrODucTION New chemical entities
Page 89 and 90: Medicines) is soluble in 250 ml or
Page 91 and 92: dissolution profile. Furthermore, t
Page 93 and 94: of excipients should be taken into
Page 95 and 96: claSS III Low permeability High sol
Page 97 and 98: obtained by altering essentially on
Page 99 and 100: authorities, the number of approved
Page 101 and 102:
The criteria set in PQP for BCS Cla
Page 103 and 104:
BCS Class III drugs For BCS Class I
Page 105 and 106:
cONcluSION The approach of waiving
Page 107 and 108:
17. Becker C, Dressman JB, Amidon G
Page 109 and 110:
Granero G, Longhi M, Becker C, Dres
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