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CH1handouts_drug_development

CH1handouts_drug_development - Biotechnology and health...

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1 MPET: Drug development Biotechnology and health diagnostics therapy : products drug development: process MPET: Drug development Biotechnology and drug development search for pathogenic mechanisms of disease target identification and validation screening for molecules MPET: Drug development Drug development direct identification: insulin, erythropoietin serendipity: penicillin rational screening MPET: Drug development Drug development: phases 1. Discovery Research 2. Preclinical testing 3. Clinical testing 4. Registration and marketing 5. Post-marketing surveillance MPET: Drug development Discovery Research (rational screening) Deliverable= isolation or synthesis of a new substance with biological activity and potential therapeutic value 1 . Target identification 2. Target validation 3. Assay development 4. High throughput screening and lead-identification 5. Lead optimization/candidate selection MPET: Drug development Target identification molecule to which the drug is aimed (receptor) quantity or activation changes and correlates with disease identified by direct analysis or “omics” drugable target
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