The selection of marmoset monkeys ( Callithrix jacchus) in pharmaceutical toxicology

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The Journal focuses on Marmoset, Callithrixjacchus, pathology, toxicology, ferret, and minipig. Priortocontrolledclinicaltrialsinhumanvolunteersorpatientsitisrequiredthatnovel pharmaceuticalsareevaluatedforpre-clinicalsafetyinarodentandanon-rodent(`second’) species.Inmostcasestherodentspeciesusedhasbeentheratandthesecondspecieshasbeen thedogormacaque(usuallycynomolgusorrhesus)monkey.However,thereisanincreasing trendwithintheUnitedKingdom(UK)pharmaceuticalindustrytousethecommon marmoset (Callithrixjacchus )forpre-clinicaltoxicologyprogrammes. Thispaperexaminesthepracticalityofusingthecommonmarmoset(henceforthreferred toas`themarmoset’)intoxicologicaltestingandreviewsmetabolicandpharmacodynamic similaritiesbetweenthisspeciesandhumans.Itthendiscussessomeoftheadvantagesand disadvantagesoftheuseofthisspecieswhencomparedwithtwootheralternativestothedog andmacaque,namelytheferretandminipig.Inparticular,themarmosethasclearadvantages overthemacaqueintermsofanimalwelfareandpracticality.Thereisregulatoryacceptance ofthisspeciesforInvestigationalNewDrug(IND),ClinicalTrialExemption(CTX),New DrugApplication(NDA)andMarketingAuthorizationApplication(MAA)registrations. Whilstthedogislikelytobemaintainedastheprimarynon-rodentspeciesintoxicology,the marmosethasbeen,andwilllikelycontinuetobe,adoptedasanadditionalnon-rodent speciesinpre-clinicaltoxicologyprogrammeswhereappropriate.
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