Target Identification, Hit Identification, Lead Compound, Pre-clinical Testing
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Outline how a drug is permitted for trials?
Company file an investigational new drug (IND) application with US FDA. Application is reviewed to ensure patients do not face unreasonable harm.
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Following trials how can companies begin to sell their product.
Following trials if the compound has shown to be safe and effective in humans. Sponsors may submit a New Drug Application (NDA) to the FDA. If approved it can be marketed and sold.
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How long does the whole process take?
20 years
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Outline the process.
Activity Screening. Pre clinical testing. Phase1,2,3 drug registration, product launch, phase 4 studies, post marketing development, down regulation.
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Three ways pharmaceutical companies work to improve drug development?
Reduce time from concept to market, Develop compounds with not obvious medical or pharmaceutical problems. Pharmacovigilance
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