THe BIOWaIVer MONOGraPHS - FIP

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THe BIOWaIVer MONOGraPHS – WHaT HaVe We learNeD? D.M. Barends1, V.P. Shah2 and J. Dressman3 1International Pharmaceutical Federation (FIP), The Hague, The Netherlands 2International Pharmaceutical Federation (FIP), North Potomac, Maryland USA 3Goethe University, Frankfurt am Main, Germany The views expressed in this paper are the personal views of the authors and not necessarily of the fIP focus Group “BcS and Biowaiver” Address correspondence to: Prof. Dr. Jennifer Dressman (Telephone +496979829680, Fax +496979829724, email: Dressman@em.uni-frankfurt.de) 8
STarTING POINT Of THe PrOJecT – 2004 In 2004, our first Biowaiver Monograph was published as a commentary in the Journal of Pharmaceutical Sciences. This commentary addressed the possibility of applying the biowaiver to three active pharmaceutical ingredients (API): verapamil hydrochloride, propranolol hydrochloride, and atenolol. 1 Regulations on biowaivers already existed at that time, according to which an in vitro instead of an in vivo assessment could be used to assess bioequivalence for a new tablet or capsule, or a new formulation of an existing immediate release dosage form. On the basis of the in vitro assessment, a new drug product could be considered bioequivalent to its reference product, without having to perform a pharmacokinetic study in human volunteers. To generally describe the use of an in vitro assessment to waive the need for in vivo (bio) studies, the term “biowaiver” was coined. As this term was originally applied to waiving in vivo studies for registration of lower dosage strengths of drug products, the more precise term “BCS based biowaiver” is sometimes used to distinguish biowaivers based on BCS considerations from biowaivers used for the approval of lower dose strengths of a product. As the various regulations described the in vitro methods to be used by the applicant, rather than providing data for actual drug substances or indicating specifically for which drug substances a BCS based biowaiver might be applicable, and since at that time open literature on the subject applying the biowaiver was scanty, it seemed logical to consider the BCS based biowaiver on a case by case basis. A further driving force for generating the Biowaiver Monographs was that the regulations differed among the various agencies and it was intended for the Biowaiver Monographs to provide a venue to open up a scientific debate about the differences in these regulations. Because of this lack of harmonization of existing guidances, it was also agreed to attempt to come to the best scientific decision for a given drug substance, based on existing information, rather than just applying one or more of the existing regulations unquestioningly. When the recommendation differs from one or the other of the guidances, this also provides an impetus to re-examine the basis of the particular guidance. 9
Page 3 and 4: Preface For 100 years, the Federati
Page 5 and 6: 1. Amidon GL, Lennernäs H, Shah VP
Page 7: Table of Contents BIOWaIVer MONOGra
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 50: 23. http://www.nihs.go.jp/drug/be-g
Page 53 and 54: INTrODucTION The demonstration of b
Page 55 and 56: Regulations in the European Union I
Page 57 and 58: Table 2. comparison of fDa, eu and
Page 59 and 60:
classification of approved drug sub
Page 61 and 62:
Table 1. The BcS classification as
Page 63 and 64:
It has also been demonstrated that,
Page 65 and 66:
26, 27 , for a rapidly dissolving d
Page 67 and 68:
For instance, some metabolic enzyme
Page 69 and 70:
18. NIHS. 2006. Guideline for Bioeq
Page 71 and 72:
51. S Strauch, E Jantratid, JB Dres
Page 73 and 74:
INDuSTrIal BeNefITS Of BcS BaSeD BI
Page 75 and 76:
an extensive effort going on in par
Page 77 and 78:
data, by applying the IVIVC relatio
Page 79 and 80:
The most recent development in the
Page 81 and 82:
in the pharmaceutical development i
Page 83 and 84:
efereNceS 1. Cook J.A., Davit B.M.,
Page 86 and 87:
BIOWaIVer IMPleMeNTaTION fOr IMMeDI
Page 88 and 89:
Within the BCS, based upon their so
Page 90 and 91:
Very rapidly dissolving: The WHO co
Page 92 and 93:
motility or interactions with trans
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of excipients are considered critic
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Table 4. eligibility for the biowai
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submitted. In such cases an abbrevi
Page 100 and 101:
In case of a rapidly dissolving dru
Page 102 and 103:
The BCS Class category, i.e. Class
Page 104 and 105:
comparator in bioequivalence studie
Page 106 and 107:
efereNceS 1. US, Department of Heal
Page 108 and 109:
lIST Of BIOWaIVer MONOGraPHS aS Of
Page 110:
Silva A, Cristofoletti R, Fernandes
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THe BIOWaIVer MONOGraPHS - FIP

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