Drug Discovery and Evaluation: Methods in Clinical Pharmacology PDF
Preview Drug Discovery and Evaluation: Methods in Clinical Pharmacology
Franz J. Hock Michael R. Gralinski Editors Drug Discovery and Evaluation: Methods in Clinical Pharmacology Second Edition Drug Discovery and Evaluation: Methods in Clinical Pharmacology (cid:129) Franz J. Hock Michael R. Gralinski Editors Drug Discovery and Evaluation: Methods in Clinical Pharmacology Second Edition With249Figuresand161Tables Editors FranzJ.Hock MichaelR.Gralinski CorDynamics CorDynamics Dieburg,Germany Chicago,IL,USA ISBN978-3-319-68863-3 ISBN978-3-319-68864-0(eBook) ISBN978-3-319-68865-7(printandelectronicbundle) https://doi.org/10.1007/978-3-319-68864-0 1stedition:©Springer-VerlagBerlinHeidelberg2011 2ndedition:©SpringerNatureSwitzerlandAG2020 Thisworkissubjecttocopyright.AllrightsarereservedbythePublisher,whetherthewholeor part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations,recitation,broadcasting,reproductiononmicrofilmsorinanyotherphysicalway, andtransmissionorinformationstorageandretrieval,electronicadaptation,computersoftware,or bysimilarordissimilarmethodologynowknownorhereafterdeveloped. Theuseofgeneraldescriptivenames,registerednames,trademarks,servicemarks,etc.inthis publicationdoesnotimply,evenintheabsenceofaspecificstatement,thatsuchnamesareexempt fromtherelevantprotectivelawsandregulationsandthereforefreeforgeneraluse. Thepublisher,theauthors,andtheeditorsaresafetoassumethattheadviceandinformationinthis bookarebelievedtobetrueandaccurateatthedateofpublication.Neitherthepublishernorthe authorsortheeditorsgiveawarranty,expressedorimplied,withrespecttothematerialcontained hereinorforanyerrorsoromissionsthatmayhavebeenmade.Thepublisherremainsneutralwith regardtojurisdictionalclaimsinpublishedmapsandinstitutionalaffiliations. ThisSpringerimprintispublishedbytheregisteredcompanySpringerNatureSwitzerlandAG. Theregisteredcompanyaddressis:Gewerbestrasse11,6330Cham,Switzerland General Introduction Drugdiscoveryandevaluationisamultidisciplinaryprocess.Thediscovery of a new drug starts with experiments in isolated organs or in biochemical assays, for example, in vitro receptor binding’s studies. New chemical com- pounds have to be compared with known drugs used in specific therapies. Positiveresultshavetobeconfirmedinvariousanimaltests.Thetherapeutic advancesmaybehigherpotency,fewersideeffects,longeractivity,oranew modeofaction.Manymethodsaredescribedintheliteratureandarereviewed inDrugDiscoveryandEvaluation:PharmacologicalAssays,thefirstbookof thisseries. Thestrategyofdrugdevelopmenthaschanged inrecentyears.Insteadof sequential studies in toxicology and pharmacokinetics, the parallel involve- ment of various disciplines has been preferred. Exposure to the body is investigated by pharmacokinetic studies on absorption, distribution, and metabolismatanearlystageofdevelopmentandcontributestotheselection ofdrugs.Thetermsafetypharmacology,formerlygeneralpharmacology,has been coined to describe a specific issue in addition to traditional toxicology tests. These studies are reviewed in the second book of the series as Drug DiscoveryandEvaluation:SafetyandPharmacokineticAssays. Clinical pharmacology and clinical pharmacokinetics belong together. Thereisnopharmacodynamicswithoutpharmacokineticsandviceversa.We, therefore, combined both disciplines in the third book of this series as Drug DiscoveryandEvaluation:MethodsinClinicalPharmacology,withtheaim ofdemonstratingthemutualdependencytothereader. Animportantobjectiveofclinicalpharmacologyistheearlyandongoing assessment of the safety and tolerability of a new drug. This is done by assessingthetype,frequency,andseverityofsideeffects;assessinginwhich patientpopulationthesesideeffectsmayoccuratwhichdoseorexposure;for whatduration;andwhetherthesesideeffectsarereversible.Theimportanceof an adequate selection of animal models, assessing the significance of the preclinical data obtained in the first-in-man study, has recently been shown quitedramatically. Thefirstdosestepinthefirst-in-manstudywithahumanizedmonoclonal antibody induced a cytokine release syndrome in all actively treated healthy volunteers,allofwhomsufferedlife-threatening,acuteshockandsubsequent multiorgan failure. Obviously, these severe and serious adverse results were v vi GeneralIntroduction notpredictedbytheanimalstudiesconductedpriortohumanstudies.Because of this incident, the regulators worldwide changed several processes so that thismishapfurthercouldbeprevented. Pharmacogenomicshasaninterestinginputtodrugdevelopment.Geno- mic information should enable the pharmaceutical industry to target specific patient populations that are more likely to respond to the drug therapy or to avoidindividualswhoarelikelytodevelopspecificadverseeventsinclinical studies. In this volume, the possibilities of pharmacogenomics-guided drug developmentarediscussed.Anothernewandpromisingdevelopmentisper- sonalizedmedicine.Thesenewareasarediscussedinthisedition. ThissecondeditionofDrugDiscoveryandEvaluation:MethodsinClin- ical Pharmacology is completely new organized and extended. It contains besides the former chapters several new ones, such as Clinical Studies in Infants and Geriatric Population, Traditional Chinese Medicine, Space Phar- macology,NanotechnologyinMedicine,etc. FranzJ.Hock MichaelR.Gralinski Acknowledgment We would like to express our gratitude and our sincere thanks to all authors who contributed their knowledge to this book. Furthermore, we personally wouldliketothankthefounder ofthisseriesH.Gerhard Vogel, whopassed awayin2011.HewastheEditor-in-ChiefofthefirsteditionandalloftheDrug Discovery and Evaluation titles at Springer consisting of Pharmacological Assays, Safety and Pharmacokinetic Assays, and Methods in Clinical Pharmacology. vii Contents Volume 1 PartI HumanStudiesinClinicalPharmacology ............. 1 1 MethodologiesofSafetyAssessmentinClinical Pharmacology ..................................... 3 WernerSeiz 2 PharmacodynamicEvaluation:Cardiovascular Methodologies ..................................... 19 IvanaI.Vranic 3 CharacterizationofCardiacElectrophysiologyIncluding ECG-Analysis ...................................... 51 IvanaI.Vranic 4 PharmacodynamicEvaluation:CNSMethodologies ...... 81 LynneHughes,MarieTrad,StaceyBoyer,DeborahLee,and WeiYin 5 PharmacodynamicEvaluation:PainMethodologies ....... 95 PieterSiebenga,PieterOkkerse,GuidovanAmerongen, RobertJanDoll,AlexMentink,JustinHay,andGeertJan Groeneveld 6 PharmacodynamicEvaluation:DrugDependencyand Addiction ......................................... 127 V.TenevandM.Nikolova 7 PharmacodynamicEvaluation:OcularPharmacology ..... 163 NajamA.Sharif 8 ClinicalPharmacologyofTinnitus:Designand Evaluation ........................................ 209 AgnieszkaJ.Szczepek 9 ClinicalAspectsinSleepDisordersandApnea ........... 223 ThomasPenzelandIngoFietze ix x Contents 10 PharmacodynamicEvaluation:DiabeticMethodologies ... 243 JuergenSandow 11 PharmacodynamicEvaluation:Gastroenterology ......... 263 PetarNikolov,GeorgiBanishki,andMilenaNikolova- Vlahova 12 PharmacodynamicEvaluation:Endocrinology ........... 283 MichaelA.B.Naafs 13 PharmacodynamicEvaluation:Dermatology ............ 299 LioraBikandHokBingThio 14 PharmacodynamicEvaluation:Inflammation/ Immunology ....................................... 317 JörgSchüttrumpfandMatthiasGermer 15 PharmacodynamicEvaluation:InfectiousDiseases ....... 325 SmitaBhuyan,SebastianFelgner,DinoKocijancic,and VinayPawar 16 RoleofClinicalPharmacodynamicsStudiesintheEra ofPrecisionMedicinesAgainstCancer ................. 343 FatihM.UckunandSanjiveQazi 17 PharmacodynamicEvaluation:GeneTherapy ........... 361 NicolasGrandchamp 18 PharmacologicalTherapyinInbornErrorsof Metabolism ........................................ 385 AnibhM.DasandSabineIllsinger 19 ClinicalStudiesinInfants(PediatricPharmacology) ...... 401 KarelAllegaert 20 ClinicalStudiesinGeriatricPopulation ................. 417 PetraA.Thürmann 21 PersonalizedMedicine ............................... 425 FedericoGoodsaid,FelixFrueh,andMichaelE.Burczynski 22 NoninvasiveMethodology(NMR) ..................... 439 MitulA.Mehta 23 TraditionalChineseMedicineandClinical Pharmacology ..................................... 455 AnitaChenMarshall 24 PharmacodynamicEvaluation:HerbalMedicine ......... 483 GulamMohammedHusain,MohammadAhmedKhan, MohdUrooj,andMunawwarHusainKazmi 25 ChronopharmacologyinDrugDevelopment ............. 499 BjörnLemmer 26 SpacePharmacology:HowSpaceAffectsPharmacology ... 519 VirginiaWotring Contents xi 27 NanotechnologyinMedicine .......................... 533 M.Nikolova,R.Slavchov,andG.Nikolova 28 GenderDifferencesinDrugTherapy ................... 547 AnthonyG.FenechandVanessaPetroniMagri 29 MethodologiesofPDAssessment:Scales ................ 571 RomanGörtelmeyer 30 MethodsinClinicalPharmacology ..................... 593 LorraineM.RuschandClaytonDehn 31 PharmacodynamicDrug–DrugInteractions ............. 603 MingZheng 32 MedicalDevices:DefinitionandClinicalTesting ......... 613 LeaWettlauferandDanielaPenn 33 FoodSupplements:DefinitionandClassification ......... 625 EvelynBreitweg-Lehmann,BirgitLiebscher,and CarolinBendadani 34 StemCellTherapy .................................. 637 NinaGraffmann,Lucas-SebastianSpitzhorn,SoraiaMartins, MdShaifurRahman,LisaNguyen,andJamesAdjaye Volume 2 PartII ClinicalPharmacokinetics ........................... 669 35 DoseFindinginSingleDoseStudiesbyAllometric Scaling ........................................... 671 ZhengLu,RüdigerKaspera,YoichiNaritomi,andTianliWang 36 PharmacokineticAspectsofMultipleDoseStudies ........ 683 StevenG.WoolfreyandJamesGilmourMorrison 37 DoseLinearityandProportionality .................... 695 TanjaEisenblaetter,LenoreTeichert,RonaldBurnette,and PaulHutson 38 EffectsofFoodIntake ............................... 715 TeodoraHandjieva-Darlenska 39 SpecialPopulations:ProfilingtheEffectofObesityon DrugDispositionandPharmacodynamics ............... 723 KennethT.Moore 40 SpecialPopulations:Renal Impairment ....................................... 749 GerardSanderinkandAndreasKovar 41 SpecialPopulations:InfluenceofHepatic Impairment ....................................... 759 GerardSanderinkandAndreasKovar
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