药学专业英语视听说教程 课件 视听说下篇 lecture 2 Preclinical Studies.pptx

Lecture2PreclinicalStudies

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（singledose)（repeateddose)

homologoustetratogenicityreproducibilityinvitromaximumtolerateddose

invivogenotoxicitymodelchimeratoxicokinetics

modelefficacyadverseeventscandidatevalidationpharmacokinetics

characterizationstringentgeneralsafety

PreclinicalstudyPharmacological/toxicologicalstudyPharmaceuticalstudypharmacodynamicstudypharmacokineticstudyacutetoxicitystudychronictoxicitystudyspecialtoxicitystudystructurevalidationAPImanufacturingAPIspecificationsstabilitystudyofAPImanufacturingofdrugproductdrugproductspecificationsstabilitystudyofdrugproduct

1.Whataretheprosandconsofanimaltesting?Pleasegivesupportingdetails.ProsEthicalconsiderationsContributiontothedevelopmentoflife-savingmedicationsandvaccinesSimilaritiestohumansEasiergeneticmodificationEnactmentoflawstoprotectanimalsfrommistreatment…ConsCrueltyDifferencesbetweenspeciesAvailabilityofalternativetestingmethodsAnimalabuseisstillexistingMisleadresearchersintoignoringpotentialcuresandtreatments…

1.Whyarealotofmedicalresearchesespeciallypreclinicalstudiesconductedinrodents?----Theyaresmall,easytobreedandrelativelycheaptocareforinlargenumbers;----Theyhavealotofsimilaritieswithhumans,includinggenetics,behaviorandbiology;----Largenumbersofratscanhavealmostidenticalgenomes,allowingformoreuniformandreliableresults;----Theycanbegeneticallymanipulated.

2.Whatarethesafetymeasuresresearchersbuildintominimizetheriskofadversereactionsinhumantrialfollowinganimalstudies?----Tograduallydialupthedosageatthebeginningofthefist-in-humantrial;----Tohavecleardefinitionof“working”or“beingeffective”;----Setguidelinesforadverseeventoutcomes;----Takingmoretimebetweendosingeachparticipanttoseeifsomethingbadhappens;----Totakeadvantagesofnewertechnologiestopredictdrugperformance;----Tomak