Generic Drug Product Development: International Regulatory Requirements for Bioequivalence PDF
Preview Generic Drug Product Development: International Regulatory Requirements for Bioequivalence
SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= Generic Drug Product Development SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= DRUGS AND THE PHARMACEUTICAL SCIENCES ASeriesofTextbooksandMonographs ExecutiveEditor JamesSwarbrick PharmaceuTech,Inc. Pinehurst,NorthCarolina AdvisoryBoard LarryL.Augsburger HarryG.Brittain UniversityofMaryland CenterforPharmaceuticalPhysics Baltimore,Maryland Milford,NewJersey JenniferB.Dressman RobertGurny UniversityofFrankfurtInstituteof UniversitedeGeneve PharmaceuticalTechnology Geneve,Switzerland Frankfurt,Germany JeffreyA.Hughes AnthonyJ.Hickey UniversityofFloridaCollege UniversityofNorthCarolina ofPharmacy SchoolofPharmacy Gainesville,Florida ChapelHill,NorthCarolina VincentH.L.Lee AjazHussain USFDACenterforDrug Sandoz EvaluationandResearch Princeton,NewJersey LosAngeles,California JosephW.Polli KinamPark GlaxoSmithKline PurdueUniversity ResearchTrianglePark WestLafayette,Indiana NorthCarolina JeromeP.Skelly StephenG.Schulman Alexandria,Virginia UniversityofFlorida Gainesville,Florida ElizabethM.Topp UniversityofKansas YuichiSugiyama Lawrence,Kansas UniversityofTokyo,Tokyo,Japan PeterYork GeoffreyT.Tucker UniversityofBradford UniversityofSheffield SchoolofPharmacy RoyalHallamshireHospital Bradford,UnitedKingdom Sheffield,UnitedKingdom SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= For information on volumes 1–160 in the Drugs and Pharmaceutical Science Series,Pleasevisitwww.informahealthcare.com 161. DoseOptimizationinDrugDevelopment,editedbyRajeshKrishna 162. HerbalSupplements-DrugInteractions:ScientificandRegulatoryPerspec- tives,editedbyY.W.FrancisLam,Shiew-MeiHuang,andStephenD.Hall 163. PharmaceuticalPhotostabilityandStabilizationTechnology,editedbyJoseph T.PiechockiandKarlThoma 164. EnvironmentalMonitoringforCleanroomsandControlledEnvironments, editedbyAnneMarieDixon 165. Pharmaceutical Product Development: In Vitro-ln Vivo Correlation, edited byDakshinaMurthyChilukuri,GangadharSunkara,andDavidYoung 166. Nanoparticulate Drug Delivery Systems, edited by Deepak Thassu, Michel Deleers,andYashwantPathak 167. Endotoxins: Pyrogens, LAL Testing and Depyrogenation, Third Edition, editedbyKevinL.Williams 168. GoodLaboratoryPracticeRegulations,FourthEdition,editedbyAnneSandy Weinberg 169. GoodManufacturingPracticesforPharmaceuticals,SixthEdition,editedby JosephD.Nally 170. Oral-Lipid Based Formulations: Enhancing the Bioavailability of Poorly Water-solubleDrugs,editedbyDavidJ.Hauss 171. HandbookofBioequivalenceTesting,editedbySarfarazK.Niazi 172. Advanced Drug Formulation Design to Optimize Therapeutic Outcomes, editedbyRobertO.WilliamsIII,DavidR.Taft,andJasonT.McConville 173. Clean-in-PlaceforBiopharmaceuticalProcesses,editedbyDaleA.Seiberling 174. Filtration and Purification in the Biopharmaceutical Industry, Second Edi- tion,editedbyMaikW.JornitzandTheodoreH.Meltzer 175. Protein Formulation and Delivery, Second Edition, edited by Eugene J. McNallyandJayneE.Hastedt 176. AqueousPolymericCoatingsforPharmaceuticalDosageForms,ThirdEdi- tion,editedbyJamesMcGinityandLindaA.Felton 177. Dermal Absorption and Toxicity Assessment, Second Edition, edited by MichaelS.RobertsandKennethA.Walters 178. PreformulationSolidDosageFormDevelopment,editedbyMojiC.Adeyeye andHarryG.Brittain 179. Drug-DrugInteractions,SecondEdition,editedbyA.DavidRodrigues 180. GenericDrugProductDevelopment:BioequivalenceIssues,editedbyIsadore KanferandLeonShargel 181. PharmaceuticalPre-ApprovalInspections:AGuidetoRegulatorySuccess, SecondEdition,editedbyMartinD.HynesIII 182. Pharmaceutical Project Management, Second Edition, edited by Anthony Kennedy 183. Modified Release Drug Delivery Technology, Second Edition, Volume 1, editedbyMichaelJ.Rathbone,JonathanHadgraft,MichaelS.Roberts,andMajella E.Lane 184. Modified-Release Drug Delivery Technology, Second Edition, Volume 2, editedbyMichaelJ.Rathbone,JonathanHadgraft,MichaelS.Roberts,andMajella E.Lane SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= 185. The Pharmaceutical Regulatory Process, Second Edition, edited by Ira R. BerryandRobertP.Martin 186. Handbook of Drug Metabolism, Second Edition, edited by Paul G. Pearson andLarryC.Wienkers 187. Preclinical Drug Development, Second Edition, edited by Mark Rogge and DavidR.Taft 188. ModernPharmaceutics,FifthEdition,Volume 1:BasicPrinciples andSys- tems,editedbyAlexanderT.FlorenceandJu¨rgenSiepmann 189. Modern Pharmaceutics, Fifth Edition, Volume 2: Applications and Advances,editedbyAlexanderT.FlorenceandJu¨rgenSiepmann 190. NewDrugApprovalProcess,FifthEdition,editedbyRichardA.Guarino 191. DrugDeliveryNanoparticulateFormulationandCharacterization,editedby YashwantPathakandDeepakThassu 192. PolymorphismofPharmaceuticalSolids,SecondEdition,editedbyHarryG. Brittain 193. Oral Drug Absorption: Prediction and Assessment, Second Edition, edited byJenniferJ.Dressman,HansLennernas,andChristosReppas 194. Biodrug Delivery Systems: Fundamentals, Applications, and Clinical Development,editedbyMarikoMoristaandKinamPark 195. Pharmaceutical Process Engineering, Second Edition, edited by Anthony J. HickeyandDavidGanderton 196. HandbookofDrugScreening,SecondEdition,editedbyRamakrishnaSeethala andLitaoZhang 197. PharmaceuticalPowderCompactionTechnology,SecondEdition,editedby MetinCelik 198. HandbookofPharmaceuticalGranulationTechnology,ThirdEdition,Dilip M.Parikh 199. Pharmaceutical Preformulation and Formulation, Second Edition: A Prac- tical Guide from Candidate Drug Selection to Commercial Dosage Form, editedbyMarkGibson 200. International Pharmaceutical Product Registration, Second Edition, edited byAnthonyC.CartwrightandBrianR.Matthews 201. Generic Drug Product Development: International Regulatory Require- mentsforBioequivalence,editedbyIsadoreKanferandLeonShargel 202. ProteinsandPeptides:Pharmacokinetic,Pharmacodynamic,andMetabolic Outcomes,editedbyRandallJ.MrsnyandAnnDaugherty 203. PharmaceuticalStatistics:PracticalandClinicalApplications,FifthEdition, SanfordBoltonandCharlesBon 204. GenericDrugProductDevelopment:SpecialtyDosageForms,editedbyLeon ShargelandIsadoreKanfer SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= Generic Drug Product Development International Regulatory Requirements for Bioequivalence Editedby Isadore Kanfer RhodesUniversity Grahamstown,SouthAfrica Leon Shargel AppliedBiopharmaceutics,LLC Raleigh,NorthCarolina,USA CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2010 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20130116 International Standard Book Number-13: 978-1-4200-2002-1 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. While all reasonable efforts have been made to publish reliable data and information, neither the author[s] nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. The publishers wish to make clear that any views or opinions expressed in this book by individual editors, authors or contributors are personal to them and do not necessarily reflect the views/opinions of the publishers. The information or guid- ance contained in this book is intended for use by medical, scientific or health-care professionals and is provided strictly as a supplement to the medical or other professional’s own judgement, their knowledge of the patient’s medical history, relevant manufacturer’s instructions and the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice on dosages, procedures or diagnoses should be independently verified. The reader is strongly urged to consult the drug companies’ printed instructions, and their websites, before administering any of the drugs recommended in this book. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the medical professional to make his or her own professional judgements, so as to advise and treat patients appropriately. The authors and publishers have also attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmit- ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Dan- vers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= Preface HISTORYOFTHISSERIESOFBOOKSONGENERICDRUGPRODUCT DEVELOPMENT Thefirstbookinthisseries,GenericDrugProductDevelopment:SolidOralDosage Forms,waspublishedin2005byMarcelDekker,Inc.,NewYork,aspartoftheir series in drugs and the pharmaceutical sciences. The objective of the first book wastodescribe,fromconcepttomarketapproval,thedevelopmentoftherapeu- ticequivalentgenericdrugproducts,includingregulatoryandlegalchallenges. Thesecondvolume,GenericDrugProductDevelopment:BioequivalenceIssues,was publishedin2008byInformaHealthcareUSA,Inc.,NewYork,andfocusedon problemsconcerningthescientificdemonstrationofbioequivalence(BE)oftwo drugproducts:atest(T)andareference(R)product. ABOUTTHISBOOK Thisbook,thethirdinthisseriesonGenericDrugProductDevelopment,provides informationontheregulatoryrequirementsforbioequivalenceinseveraldiffer- entcountriesaroundtheworld. The advent and application of bioequivalence testing has had a signif- icant impact on the process of drug product development both for innova- tor/brandpharmaceuticalmanufacturersandalsoforthegenericdrugindustry. Intheformerinstance,innovator/brandcompanies’useBEduringtheirformu- lationdevelopmentofproductspriortoembarkingonclinicalstudiesonsafety andefficacyandsubsequentlytofacilitatepostapprovalchangesinformulation. Generic drug manufacturers, on the other hand, are able to circumvent clinical trialsinpatientsbyusingBEtoobtainmarketapprovalfortheirproducts. Although the underlying scientific principles of BE have been well- established and many drug regulatory agencies around the world have largely adopted standard methodology and acceptance criteria, some differences exist intheapplicationofthemethodologyandinterpretationoftheoutcomesamong differentcountries.HencetheobjectiveofthisbookistooutlinethespecificBE requirements of each of the included countries where such information will be useful to prospective generic drug manufacturers intending to obtain market approvalinaspecificcountry. CONTENTS Thebioequivalenceregulationsandrequirementsofthefollowingcountriesand theirassociatedregulatoryagenciesareincludedinthisbook: vii SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= viii Preface (cid:2) Australasia—TherapeuticGoodsAdministrationofAustraliaandMedsafe,a businessunitoftheNewZealandMinistryofHealth (cid:2) Brazil—The National Agency for Sanitary Surveillance (Agencia Nacional deVigilanciaSanitaria,ANVISA),GeneralManagementofGenericProducts (GereˆnciaGeraldeMedicamentosGene´ricos,GGMED) (cid:2) Canada—Health Products and Food Branch (HPFB), Therapeutic Products Directorate(TPD), HealthCanada (cid:2) European Union—European Medicines Agency (EMEA), Committee for MedicinalProductsforHumanUse(CHMP) (cid:2) India—Central Drugs Standard Control Organization (CDSCO) under the Government of India having certain powers vested in them and each State hasitsowndrugregulatorysystemhavingcertainpowers (cid:2) Japan—TheMinistry ofHealth,LabourandWelfare(MHLW)inaccordance withthePharmaceuticalAffairsLaw (cid:2) South America—In accordance with guidelines of PAHO (Pan American Health Organization) through PANDRH (Pan American Network for Drug RegulatoryHarmonization) (cid:2) SouthAfrica—MedicinesControlCouncil(MCC),DepartmentofHealth (cid:2) Taiwan—TheBureauofPharmaceuticalAffairs(BPA),DepartmentofHealth (DOH) (cid:2) Turkey—TheGeneralDirectorateofDrugandPharmacy(GDDP,Ministryof Health(MoH) (cid:2) UnitedStatesofAmerica—FoodandDrugAdministration (cid:2) WorldHealthOrganization(WHO) The chapters include background information and history of the devel- opment of rules, regulations, and guidelines in a specific country along with patentinformationandnationalrequirementsforinterchangeabilitywheresuch requirementsexist. Thisisfollowedbybioequivalencerequirementsincluding thechoiceofreferenceproduct,bioequivalencemetricsused,andacceptancecri- teriaaswellasstudydesigns forimmediate-releaseandcontrolled-/modified- release products for oral administration. Sections also include information on therequirementsfortheassessmentoffoodeffects,metabolitesandchiraldrugs, useof“add-on”andsteady-statestudies,conditionsforbiowaivers,bioanalyti- calandstatisticalrequirements.Mostoftheguidelinesalsoincluderecommen- dations for the assessment of drug products not intended for absorption into the systemiccirculation such as topicalproducts for local/regional action(e.g., dermatological corticosteroid products and other creams, gels, ointments, and lotions as well as nasal sprays/aerosols and oral inhalation products). In addi- tion, the bioequivalence requirements for postapproval formulation changes, biowaivers for additional strengths of the same product, and the use of disso- lutiondataforbiowaiversarealsoincluded. Bioequivalence has been acknowledged as a valuable tool and has been used as a surrogate measure to assess the safety and efficacy of generic medicines, also termed multisource products. However, as mentioned previ- ously, in general, the methods used and the bioequivalence requirements of most regulatory agencies have much in common, but in some countries spe- cificissuesandapproachesdiffer.Thisvolumeprovidesrelativelydetailedinfor- mationrequiredbytheregulatoryauthoritiesofseveraldifferentcountriesand SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= Preface ix the implications of their different requirements and approaches for the market approval of a generic product, particularly with respect to it’s declaration of interchangeability/switchability. A list of definitions, abbreviations and symbols has been included where manyofthetermsarecommonlyusedinmostcountries. IsadoreKanfer LeonShargel SPH SPH IHBK055-FM IHBK055-Kanfer January8,2010 19:20 CharCount= Acknowledgments Theeditorswishtoexpresstheirgratitudetoalltheauthorswhohavegivenso generouslyoftheirtimeandexpertisetoprovidethesetextsandtotheorganiza- tions,forwhichtheywork,whichhavegraciouslyallowedthemtodoso. x
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