Advanced Issue Resolution in Safety Pharmacology PDF
Preview Advanced Issue Resolution in Safety Pharmacology
Advanced Issue Resolution in Safety Pharmacology Edited by Mary Jeanne Kallman Michael K. Pugsley Academic Press is an imprint of Elsevier 125 London Wall, London EC2Y 5AS, United Kingdom 525 B Street, Suite 1650, San Diego, CA 92101, United States 50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom Copyright © 2019 Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechani- cal, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permis- sions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions. 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To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library ISBN: 978-0-12-812206-8 For information on all Academic Press publications visit our website at https://www.elsevier.com/books-and-journals Publisher: John Fedor Acquisition Editor: Erin Hill-Parks Editorial Project Manager: Jennifer Horigan Production Project Manager: Sreejith Viswanathan Cover Designer: Mark Rogers Typeset by TNQ Technologies Contents LiosftC ontri.b.u.t.o.r.s. .......................x.i. ............................................................ Chap1t:eI rn trodtuoIc stsiRuoeens ol.u.t.i..o.n. ...................1. ................................. Mary Jeanne Kallman References. . ....... .... .............. . . .6 ......... . ... ... ... .... ................................... .. .. ... ... .... .... ..... ..... . Chap2t:eS re lecotfNi oonnt radSipteicofinoeaIrsls sRuees olSuttuido..i.n..e ...s.. ..7. ... JudiWt.h H enck SpeciSeesl ectfioorNn o nclinSiacfaeltP yh armacolSotguyd ies 7 ................................. SpeciCeosn sirdaetiofnosTr e stionfSg p eciOfrigca Sny stems . 9 ............. ..................... CentrNaelr vouSsy ste.m . . 9 ........ ......................................... ......... .............. .......... ......... . Cardiovas.c.u.l.a.r. ...............................1.9. ..................................................................... Respira.t.o.r.y. ...................................2.2......................................................................... Renal 25 ........ .............. ......................... ............ .................. ............. ............ ....... ........ ...... Gastrtoeisnti.n.a.l.. .................................2.8. ................................................................... SpeciCeosn sideraftoiTroe nsst ionfBg i opharrnaceu.t.i.c.a.l.s. .............3..1.. ............. ... Conclus.i..o.n.. ..............................................................................................33.. .......... .. Referen.c.e.s. ......................................................................................3....4.... ............... .. Chap3t:eT rh Ues oef M odeltioFn agc ilDietcaitsei oni-nSM aafkeitnyg PharmacAoslsoegys s.m.e.n...t.s.. ..................................41 .... . .. . .. . . . . . . .. .. . . DereJk. L eishman WhatA reM odel.s.?. ................................................................................4 ..2.. ........ . . . . . . . TheS pectraunmd S caloefP harrnacokainndeP thiacr rnacodynMaorndiecl. s. ...4.2. .... EmpiriMcoadle ls-WhAarteT hey.?. ..........................4.2............................................ Illustroaftt hieUo tni loiftE ym piriMcoadle l.s. .....................4.5................................... Semmie chaniMsotdiecl .s. ...............................5.0.......................................................... QuantitaStyisvteeP mhsa rmacolMoogdye l.s.. ................. .....................5. 3 . .. . .. . . .. .... . .. . . SysteFmisr st MTahcehni nLee amin.g. .......................5..4............................................ Conclusio..ns . .... . .. . . . 57 .. . ........ .......... .... ................................... .......... ..... .... .... ................ Disclari. 1.n.e......................................................5.7. ........................................................ References . . . . 57 ................ ........... ..... ............................................ ............... ................. ... v vi Contents Chap4t:eI rs sRuees olouftD iroung -InBdruecaetdIh nisntga bility antdh Oec curroefAn pcneeE ivce nts 61 ................................................... DenniJs.M urphy IntroducttoBi roena thIinnsgt abili.ty . ..... . ..... .. . 61 ....... ......... ..... .. .. .. ....... .... .. . ... ... . ... ....... MeasuremeanntdDs e fini.t.i.o..n....s. ...............................................61 . . . . . . . . . . . . . . . . . . . . . .. ... . SleeApp neaan dM echaniosfmT oxici.t..y. . ......... ... ... .. . .6 2 . . ........ . . . . ..... . ....... . ... ... . ..... ... IssuAesss ociaWtietdh BreaItnhsitnagb .i.l.i.t.y. ............................6.4. ............. ... . . . .. .. . . Acutaen dC hronAidcv erOsuet come.s.. . .... . . ... .....64 .. . . . ............. . . ... ... ....... . .. ......... ..... .. . PharmacoloAggiecnatalsn dB reathIinnsgt ab.i.l.i.t.y. .............6.5. ................................ Resolutoifto hneD rug-InduBcreedat hIinnsgt abiIlsistu.y.e. ...................6 .8. . .. ..... ... ... Methodolo.g.i.e.s.. ...............................................................................6.8. . . . . . . . . . . . . . . . .. . . . . AnimaMlo del.s.. ........................................................................68 . . . . . . . . . . . ... . . . . .. . . . . . . . . . . . . ProposSetdr at.e.g.y. ................................6.9. ................................................................. CasSet ud.y. ......................... ............................................ ..71 .. . . . . ... . . . . ... . . . . . . . . . . . . . . . ... . ... .. . Acknowledgm.e.n..t.s... ........ .....................................................7 2 .. . . . .. . .. ... . . . .... . . . . .. ... .. .. Referen.c.e.s . .. .. ............................... .... . 72 . .... ..... .... . .... ........ . . . . ... . .. . ... ... ... .............. .......... Chap5t:eT rh Iem paocfDt r ug-InEdffueccoetndts h Gea stroinStyesstteimn:a l ChalleanngIdes ssR uees olfuotSria ofneP thya rmacology 77 ...................... MariLeu-ceR osseeRlesn,a uFdl euranScues,aM n. G.G oody Introduction . .. . 77 ........................................ ........... . ................................ ........................ CommonG astrointeEsftfienciatnNls o nclinSiacfaelEt vya luatio.ns 82 .... ................... Vo1nit(iEnmge si.s.). ................................8.2. ................................................................. Diarrhea 84 ...................................................................................................................... PotentIimapla cotfG astrnotiestiEnffaelc tosnC orSea fePthy armacology OrgaSny s teins . ... . ... 87 ..................... .................................... ..... .. .. ....... ... . . ...................... DireEcftf ec.t.s. ..................... .........................................87 ... . . . . . .. . . ... . . . . . . . . . . . .. . . .. . ... ... . .. . . . IndirEeffcetc ts 88 ............................................................................................................ ExamplWehse rGea strointEesftfiencMatalsy I nterWfietrhSe a fety PharmacolEovgayl uati.o.n..s.. ....................................... ..89 .... . . . . . . . . .. . . . . . . . . . . .. . . .. . . . . .. . ... ... MitigatSitorna te.g.i.e.s. ............. ...........................................9.1. .. ..... . ....... ..... ..... .. . . .. .. ... AdaptiFnogr mulat.i.o.n.s. ............................9.1. ............................................................ AdaptitnhgeR outoef A dministr.a.t.i.o.n. ...................9.2. ............................................. AdaptitnhgeD osinRge gim.e.n. ................................................................9.3 . . . . . . . . . . . . . ... AdaptitnhgeF eediRnegg ime..n. ....................................................93 . . . . . . . . . . . . . . . . . . . . . . .. . . . AlterAinnigm aClo nscious..n.e..s.s.. ............................................ ...9.4 .. .... . . . . . .. . . . . . . . . . ... . DesensitiozraD teivoenl opmoefnT to leratnocG ea strointeEsffteicnt.as.l . ......9.4 .. . .. . . ConclusiaonndFs u turDei rect.i.o..n..s.. ................................... 95 . . . . . .. ... . . . . .................... Footnot..es. ..............................................................................96 ... .... . . .. ... . . . . . . . . .. . .... ... .... Referen.ce.s. ............ . .......... ........ ......... . .. 96 .. .... .. .. ... ... .. .... ... .. . . .... ... .... .. ... ... .. .. ......... .... .... Chap6t:eS rl eaenpd SDlieserpu ption 103 ............................................................... Joanne StevCeanrsr,Mi aer kgraf TheI mportaonfcS el ee.p. ...............................1.0.4. ....................................................... MeasuriSnlge ep ... . . . . .. . . . . 105 .............. .............. .. ..... ..... ... .............. ....... .. .... ....... ..... ..... ... Contents v11 SleeSpt ag.e.s. ..................................................................................1...0...6... ................ TranslataobfEi lleicttyr oencephailnoSg lreae.pp.h .y. ....................1..0..9.. ............ ....... ElectroencephalForegqruaepnh.cy.i .e.s. ..........................................1...1..0.. ....... .......... REM,N on-REMa,n dW akefulnaessa Ts ranslatBaiboml aer ke.r. .........1.1.2. .............. ChangeisnS leePpa tteWrintshA gin.g. ...........................................1.1.2. ..................... NondruDgi sruptoifSo lne e.p. ............................1.1.2. ................................................... Drug-InduScleedeD pe priva.t.i.o.n. .......................1.1.6. ............................................... RapiEdy eM ovemenStu ppres.s.i.o.n. ......................1.1.6. ............................................. GenerSalle eDpi sturba.n.c.e.s. ............................................................1..1..8.. ............... Modelosf S leeDpi sturb.a.n.c.e. .........................1.1.9. ................................................... CircadRihaynt hn.1s . ... ...... . ]1 9 . ..................... ..... . .. ..... . .. .. ......... ............ .......... ............ .... UsinGge netMiocd eltsoT argSelte eDpi sruptainodNn o rmaliSzlee e.p. .....1.2.2. ....... DisruptoifSo lne eipnD iseaSstea t.e.s. .......................1.2.3. .......................................... Summary 124 ....... .............................. ........ ....... ............ ..... ............. ........ ......................... Referen.c.e.s. .....................................1.2.5. ..................................................................... Chap7t:eS re lIfn jurBieohuasvi inCo lri naincPdar le clPionpiuclaalt ions: DescriEpttiioolanon,gyMd ,a nagement 131 ............................................. ThomaJs. H udzik Introduc.t.i.o.n. ...................................1.3.1. ................................................................... Self-rIinojuuBse havior Ov.e.r.v.i.e.w. ..............................................1...3...2... .............. Self-InjuBreihoauvsii onNr o nhumaEnx perimeSnutbajle c.t.s. .........1.3.4. ................. Drug-InduSceeldf -InjuBreihoauvsi. o..r. ... ...... ..... ..... .134 . . ...... .... . . . ...... . ... . . ...... ... . ...... .. ToxicolSotguyd i.e.s. ..................................1..3..6.. ......................................................... Su1nma.r.y. ..................................................................................1...3...7... ................... .. Acknowledg1.n.e.n.t.s. .................................................................1...3...8... ............ ........ Referen.c.e..s.. ...................................................................................1..3..8.. .................. Chap8t:eA rp proafcohErea srI lyd entifiocfAa btuisPoeon t enLtiiaabli lit1y4 3 ............ MichaDe.lB S.w edberg Introduc.t.i.o.n. ..................................1.4.3. .................................................................... WhichC ompoundPsr eseanntI ssufoer P reclinDircuagAl b usLei ability Assessme.n.t.?. ...................................1.4..4. ................................................................... CompoundDsoc umentedN ott oM aintaDirnu gA bus.e. .............1.4.4. ......................... CompoundWsi thM echanisDmosc umentteodM ediatDeru gA buse .. .144 ............ ..... . CompoundWsi thM echanisomfsU nknowRni sfko rD rugA buse . 145 .... ................. .... AnI ntegrAaptperdo afcohAr s sessmoefnD tr ugA busLei abi.l.i.t.y. .....1.4.6. .............. ObservatSitoundailfe osrD eetctiOnvge rBte havioErfafle c.t.s.. ........1.4.7. ................. PsychoacEtffievcet .s. ................................1.5.0. ............................................................ AssessiRnegi nforcEiffnegc tosfD rugsS,e lf-Adminis.t.r.a.t.i.o.n .....1.5.3. .................. ExamploefsA busLei abilIistsyuR ee soultio.n. ...................1.5.4. ................................. mGluRA5n tagonfoirs Ptasi ann dA nxietNyM:D A-LikoerO ther AbuseL iabilPiottye nt.i.a.l.?. ..........................1.5.4. ....................................................... A PeripheArcatlilnyµg - OpioAinda lgesHiocw:P eriphe.r.a.l.?. .......1.5.9. ................... A <5-0pioidA gonifsto Pra inµ:- OpioEifdf ecat CsN,S Stimula.nt.?. . .1 61 . .... .. ... ........ .. Obrapsr otegipodra Dsi reidteoA su tor viiiC ontents Sutnmaarnyd C onclusions 164 ................................ ....................................................... References .167 ............................................................................................................... . Chap9t:eI rs sRuees olouftM iootnoD re ficaintSdst ereotypies 17 1 .......................... DaviVd. G auvin Rodents 177 ........................................................ ............................................................. NonhumaPnr imat.e.s.. ...................................l.7 .9. ....................................................... PreclinSiccraele ni.n..g. .............................................................1 .82 .. . . .. . . .. .. .... .. . ... .. . . . .. . BehaviaosBr r aiFnu ncti.o.n. ...............................................................1..8.2 ... .. .. . . .. . . . . . . Behaviaosar B iomar.k.e.r. ........................................1..8..3.. .................................... .... . Behaviaosar T ool....... ............................................1..8..6.. ........................................... . Behaviaosar C onfoun.d. ..............................................................1 88 . . .. . ... . . . . .... . . . .. . . . . . . . RepetiBteihvaev iTohrasMt a yN ot BStee reot.y.p.i.e.s. ...........1.9.0. ........................... CasEex ampl.e. ............ ............... ....... .........1 92 .. . . . . .. .. . ........ . .. . . . . . .. .. . ... ... .. . . . .......... . . . . . . ... Conclusion 194 ................................................................................................................ References . . 195 .............. .................. ............................................................................... FurthReera ding 201 ..................... ............................... .................................................... Chap1t0e:Ir s sRuees olRuetliaotntoC e odn vulPsriovfiel es 203 ................................. MarcuSs. D elatte Introduction 203 .............................................................................................................. Determintihneg Biological oPfla a DursuigPb rioldiutcyia nC go nvulsion 204 ........... Assesstihneg RoifsC ko nvulsants 205 .................................... ....................................... Assays UtsoEe vda luaCtoen vulsions . . 206 .................... ........ ....... ....... .................. .... .... Factors MTahyIa ntc reSaussec eptitboiC lointvyu lsi.o.n.s. . ...... .2 06 . .. ....... .... .. ... ......... DatNae edetdoC onducaRt isAks sessment . 209 ........ .... ............................................... ChallenTgheasMt a yI nflueanR cies Aks sessme.n.t. .............................2.1 1 . .. .. . . . . . . ... .. Managitnhge R isokf D rug-InduCcoendv ulsiaonndSs e izure.s 215 ...... ...... ................. UsinNgo nclinDcaatlta o D etermiSnaef e Clinical Exposure Le2ve16l s .... .................. Discussio.n.. .... ........ .................... . ........ ....2 18 ..... . ... ... . ... . .... . ... ... .... ... ... ... ... ... . ... ... .. . . ..... .. Disclai.m..e.r. ..................................... ......................2 20 . . .. .. ... ... ... .. ... ... .. . . . ... . . . .... . . . ... .. . .. References . . .................. . . .. ... .....2 20 ............. .... ..... .. .. . .... .. . .. .... . .......... ........ .... .. ........ . ... . . .. Chap1t1e:Ur t iloifPt ryo greRsastiSivcoeh edoufRl eeisn forcement in AbusPeo tential Assessments 225 .......................................................... JamiKe. D aSilvDaa,v iBd. H ortoPna,u Blu tler, SusaMn. G.G oody Introduction . . .225 ........................................ .............................................. ............... ..... . StudDye sigCno nsiderat.ions 229 .... ............................ ................................... .......... ...... StudSyt ruct.u.r.e .. . . . . . . .2 29 .. . ......................... . ...... ....... ............ ...... ................ ....... .......... TesStu bjeCcotn sidera.t..i..o.n.s... ..................................2 32 . ... . . . . . .. . ... .. ........ . . .... . .. .. . . ... . SelectoifTo nri aninDgr ug. . . . . . . 240 .. ... ...... .............. ....... ......................... ...... ....... ...... .... OtheUrs eosf P rogresRsaitviSeoc heduolfeR se inforce.rn.e.n.t..... ....2.4.2. ................. Conclus.i.o.n. ....................................2.4.5. ..................................................................... Footno.t.e.s. .....................................2.4.5. ....................................................................... References. .2 46 ......... ................................................ ...................................................... Contents 1x Chap1t2e:Ar p plicoafIt miaognii ntn hgRe e solouftS iaofne ty PharmacIoslsougye s 25 1 ...................................................................... EriTc.R ossman SelectoifoIn n V ivoI magiTnegc hniq.u.e.s. .......................2..5..2.. ....... ......................... Sonograp(hUylr tasou.n.d.). ............................2.5.4. ....................................................... MagnetRiecs onanIcmea gi.n.g. ....................................................2...5...4. . .................... Radionuc(Nluicdlee aIrm)a gi.n.g. .........................2.5.5. ............................................... ApplicaotfiI onVn i vIom agiTnegc hniq.u.e.s.. .......................................2..5..5.. .. ......... CasSe tud#y1 :C ardiUalct rastruCchtaunrgee( sM yofiDbeegre neration) ina RepeaDto seG enerTaolx iciMtouys eS tud.y. .................2.5.6. ............................... CasSe tud#y2 :R educeBdr aiWne ighitnP revioRuesp eaDto se GenerTaolx iciRtaytS tud.y. .............................2.5.7. ..................................................... CasSe tud#y3 :S tructCuarradli Cahca nge(sH ypertroipnRh eyp)e at DoseG enerTaolx iciRtatyS tudi.e.s. ........................2.5.8. ............................................. CasSet ud#y4 :C ardiCahca nge(sIc nreasceTdn LIe velisnR) e peat DoseG enerTaolx iciDtoygS tud.y. .........................2.5.9. .............................................. CasSe tud#y5 :D ecreasCeadr diCaocn tract(inIlcirteya sQeAd I nterval) ina C ardiovasDcouglS aarf etPyh armacolSotguyd. y. ...............2.6.0. .......................... CaseS tud#y6 :C ardiotoxIidceinttyi ifniH eudm anC liniSctauld ies FollowTinrega tmeWnitt hC ompoundosfa S imilMaorl eculTaarr get: TyrosiKnien asIen hibi.t.i.o.n. ..........................2.6.1. ..................................................... FuturReo loef I magiinngS afetPyh armacol.o.g.y. .....................2..6..2.. ........... ........... References 265 ...... ............................... ............. ............. ................ ............ ............ .......... Chap1t3e:Cr a rdiovSaasfceuPtlhyaa rr macIoslsoRugyee s olution 267 ........................ AnniDee launoMiasr,i e-LRuocses eeJlesa,n -PiVearlreen tin IntroducCtairodni:o vasScaufeltayIr s suiensD rugD iscovearnyd Developm.e.n.t. .............................................................................2...6..7.. ................ ..... ZD6126U:n derstantdhieMn egc hanisomfDs r ug-InduCcaerdd iac ToxictiotR ye sumCel iniTcraila .l.s. ...................................................2....6....8 .. ........... AZD7762:I nfluencPihnags IeC liniTcraaill Dse sigfno olwling Nonclinical Charaocftt heeNr oinzcaltiinoCinac radli ovasTcouxliacr.i .t.y. ..2.7.1. ...... HydroxyzainndeQ T Prolongation/DTeoPi o-isnatdReeisss k: SupporttihnPego stapprCoovmamli tmen.t..... .................................2..7..4.. ................. . CetiriaznidnL ee vocetirHiozwiW noeu:l dC iPAH aveI mpact.e.d.?. ......2.7.7. ............. Su1n1uaanrdyC onclus.i.o.n. ....................................................2..8..0.. ........................... Referen.c.e.s. ..........................................................2.8.1. ................................................ Chap1t4e:Ur s oef I nV itro MionDd reuDlges v elopamneIdns ts ue Resolution 287 .................................................................................... Davi0d. C alligaro BroaSdc reeniPnagn eSle lect.i.o.n. .......................................2..9..4.. ....... ...................... Conclus.i.o.n. ....................................2.9.8. ..................................................................... Referen.c.e.s. ....................................2.9.9. ......................................................................
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