文档介绍：NONCLINICALNONCLINICAL SAFETYSAFETY STUDIESSTUDIES
OFOF NEWNEW DRUGDRUG
財團法人醫藥品查驗中心財團法人醫藥品查驗中心
藥毒理審查員藥毒理審查員汪徽五汪徽五
9292年年88月月2929日日
CI-2
OutlineOutline
GeneralGeneral PrinciplesPrinciples ofof NonclinicalNonclinical SafetySafety StudiesStudies
TypesTypes ofof ToxicologyToxicology StudiesStudies
SafetySafety PharmacologyPharmacology
TimingTiming ofof NonclinicalNonclinical SafetySafety StudiesStudies
ConclusionConclusion
CI-3
GeneralGeneral PrinciplesPrinciples ofof
NonclinicalNonclinical SafetySafety StudiesStudies
GoalGoal ofof nonclinicalnonclinical safetysafety evaluation:evaluation:
–– AA characterizationcharacterization ofof toxictoxic effectseffects
•• ans, DoseDose dependence,dependence,
RelationshipRelationship toto exposure,exposure,
PotentialPotential reversibilityreversibility
–– EstimationEstimation ofof anan initialinitial safesafe startingstarting dosedose
forfor humanhuman clinicalclinical trialstrials
–– GuideGuide dosingdosing regimensregimens andand escalationescalation
schemesschemes
–– IdentificationIdentification ofof parametersparameters forfor clinicalclinical
monitoringmonitoring forfor potentialpotential adverseadverse effectseffects
CI-4
新藥研發流程
7
CI-5
Nonclinical Studies
Pharmacodynamics/Pharmacology
Safety pharmacology
ics/ics
General toxicology
ic toxicity
Reproductive toxicity
Carcinogenicity
Special toxicity
CI-6
ICHICH SafetySafety TopicsTopics
InternationalInternational ConferenceConference onon HarmonisationHarmonisation
ofof TechnicalTechnical RequirementsRequirements forfor RegistraRegistrationtion ofof PharmaceuticalsPharmaceuticals forfor HumanHuman UseUse
M3:M3: TimingTiming ofof nonclinicalnonclinical safetysafety studiesstudies
S1:S1: CarcinogenicityCarcinogenicity testingtesting
S2:S2: GenotoxicityGenotoxicity testingtesting
S3:S3: ics/ics/ics
S4:S4: RepeatedRepeated dosedose toxicitytoxicity inin nonrodentsnonrodents