Walter K Kraft Fall 2018 Sage words from an olde tyme drug developer When the molecule is born its fate is determined Its up to us to find out what the truth is but in the end we cant change ID: 1046058
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1. Drug Development StagesIRB continuing educationWalter K. KraftFall 2018
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4. Sage words from an olde tyme drug developerWhen the molecule is born, its fate is determined. It's up to us to find out what the truth is, but in the end we can't change its fate.The more skilled we are, the sooner we know the fate.
5. PreclinicalIdentifying diseasesUnderstanding biology of the systemFormulating moleculesTest tube engagementAnimal testing in at least 2 species
6. Investigational New Drug (IND)FDA approval to test in humans30 days to place on holdVery high standards for manufacturing, stability, purity, proof of concept, animal
7. Phase 1Generally healthy volunteersCharacterize PharmacokineticsSafetyDrug interactionsPharmacodynamics 50-200 volunteersIn oncology, patients used
8. Phase I Oncology TrialsUsually no benefit to subjectsCommon therapeutic misconception among patientsMore recently, in healthy volunteers for non-cytotoxic drugs
9. SimvastatinPhase II dose range study in 43 individualsPhase III 4444 patient 4S trial linked simvastatin to reductions in CV in events.
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11. As IRB reviewerFDA approval does not mean everything is known about a drugWe assess risk and ensure it is conveyed to subjectsWe do not seek the fool’s errand of eliminating riskWhat stage is a drug trial?What is the specific question being asked by the study?What is the uncertainty around drug safety and efficacy?