Académique Documents
Professionnel Documents
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Origin Greek
Pharmakon A poison; drug or medicine
Logia To study
A study of
PHARMACOLOGY
Druganychemicalagentother
thanfoodthateffectsliving
organisms,inthemedicalsense,a
drugisanychemicalagentusedin
thetreatment,cure,preventionor
diagnosisofdisease.
PHARMACOKINETICSDeals
withtheabsorption,distribution,
biotransformationandexcretionof
drugs.Thesefactors,coupledwith
dosage,determinetheconcentrationof
thedrugatitssiteofactionandhence,
theintensityofitseffectsasafunction
oftime.
PHARMACODYNAMICS
Thestudyofthebiochemicaland
physiologicaleffectsofdrugsand
theirmechanismofaction,and
structureactivityrelationships.
PHARMACOTHERAPEUTICSThe
useofdrugsintheprevention,treatment
anddiagnosisofdisease.
IMPORTANT QUESTION:
TOXICOLOGYThataspectof
pharmacologythatdealswiththeadverse
effectsofdrugs.
IMPORTANT QUESTION:
ARE DRUGS GOOD GUYS OR BAD GUYS?
1)Non-prescriptiondrugs-Theseareagentsthatmaybesold
overthecounter(OTC)sincetheyarejudgedsafeforuse
withoutmedicalsupervision
2)Prescriptiondrugs-Theseareagentsconsideredtobeunsafe
foruseexceptundersupervisionandwhicharetherefore
dispensedonlybytheorderofpractitionerslicensedbylawto
administerthem,e.g.,physicians,dentists,veterinariansetc.
Proprietary name=tradename(trademarkname).This
nameisassignedbythemanufacturerandisownedbythem.
Whileunderpatentprotectionthedrugcannotbeproducedby
anyoneelse.Onceitgoesoffpatent,othercompaniesmay
manufactureitandthenewcompanymaygiveittheirtradename.
Thereforethesamedrugmayhavemorethanonetradename.
Nonproprietary name=genericname.Ifadrugispromisingand
amanufacturerwantstoputitonthemarket,aUnitedStates
AdoptedName(USAN)isselectedbytheUSANCouncilwhichis
jointlysponsoredbytheAmericanMedicalAssociation,the
AmericanPharmaceuticalAssociationandtheUnitedStates
PharmacopoeiaConvention.Ifthedrugiseventuallyadmittedto
theUnitedStatesPharmacopoeia,theUSANnamebecomesthe
officialname.
Kefauver-HarrisAmendments(1962)totheFood,Drug, Requiredproofofefficacyaswellassafetyfornew
andCosmeticAct
drugsandfordrugsreleasedsince1938;established
guidelinesforreportingofinformationaboutadverse
reactions,clinicaltesting,andadvertisingofnewdrugs
ComprehensiveDrugAbusePreventionandControlAct Outlinedstrictcontrolsinthemanufacture,distribution,
(1970)
andprescribingofhabit-formingdrugs;established
programstopreventandtreatdrugaddiction
OrphanDrugAmendmentsof1983
AmendsFood,Drug,andCosmeticActof1938,
providingincentivesfordevelopmentofdrugsthattreat
diseaseswithlessthan200,000patientsinUSA
DrugPriceCompetitionandPatentRestorationActof
1984
Abbreviatednewdrugapplicationsforgenericdrugs.
Requiredbioequivalencedata.Patentlifeextendedby
amountoftimedrugdelayedbyFDAreviewprocess.
Cannotexceed5extrayearsorextendtomorethan14
yearspost-NDSapproval.
ExpeditedDrugApprovalAct(1992)
AllowedacceleratedFDAapprovalfordrugsofhigh
medicalneed.Requireddetailedpostmarketingpatient
surveillance.
PrescriptionDrugUserFeeAct(1992)
Manufacturerspayuserfeesforcertainnewdrug
applications.FDAclaimsreviewtimefornewchemical
entitiesdroppedfrom30monthsin1992to20months
in1994.
Stagesofnewdrugdevelopment
Timeandcostprofileforthediscoveryanddevelopmentofa
drugcandidate
Howdrugdevelopabilityexperimentsfitintothedrugdiscoveryand
developmentprocess.
Scientificdisciplinesnecessaryfordrugdevelopabilityassessment.
Traditional Process
Reverse Pharmacology
DiseaseState
EndogenousLigand
ReceptorandBiological
Response
DrugCandidate
OrphanReceptor
EndogenousActiveProducts
BiologicalResponses
DiseaseState
DrugCandidate
ASanFranciscoopiumden
Instantaneouscurewithcocainetoothache
drops
-AlbertSzentGyorgyi
Theoriginsofpharmacology:religion,animals,andplantsFriezefromthepalaceofKingSargonII,inKharasabad.
MuseeduLouvre,Paris,AntiquitesOrientales.(CourtesyofServicedeDocumentationPhotographiquedelaMusees
Nationaux,ChateaudeVersailles)
Foxgloveanddeadlynightshade.Thesearetheplantsourcesofdigoxinand
atropine,respectively,(ReproducedwithpermissionfromGeorgeGraves,
MedicinalPlants,NewYork:CrescentBooks.Copyright1990BrackenBooks.)
Thearabicwordal-kuhloralcohol.Itoriginallyreferredtooneof
thefirstwaysofpreparingdrugsforexternaluse.
The three important figures in the early history of pharmacology are Rudolf
Bucheim, Oswald Schmiedeberg, and John Jacob Abel (left to right). They
not only created new laboratories devoted to the laboratory investigation of
drugs, but also firmly established the new discipline through the training of
future faculty, the writing of textbooks, and the founding of scientific
journals and societies.