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PHC320H1 (52)
Giaever (11)
Lecture 3

Lecture 3 Clinical Trials

3 Pages
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Department
Pharmaceutical Chemistry
Course Code
PHC320H1
Professor
Giaever

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Description
Lecture 3 PHC320 Clinical TrialsTarget identificationHit GenerationLead GenerationEarly stage research and discoveryPreclinical AnimalsPhase 1 Safety Healthy HumansPhase 2 Efficacy Safety in PatientsPhase 3 Efficacy Safety More patientsFDA review and approvalMost fail in Phase 13 Clinical Development most costly stageTarget identificationTarget ValidationGenerate hitdevelop leadoptimize leadin vivo validationphase 1 candidatePhase 1 Safetyphase 2 efficacyphase 3 confirmPhase 4 FDA Real life patients1800s natural sources limited possibilities small scale prep by individuals unpurified no idea MOA1900s synthetic sources unlimited possibilities large scale prep by companies tight control know partly MOA molecular biology revolutionOrphan act for diseases that target 200000 peoplePerks exclusiv
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