Drug Development Process

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5 Top forms and their usage? (5)
Oral 47%, Injectables 18%, Inhalation 16%, Topical 11%, Other 8%
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Top 5 Big Pharma? (5)
Novartis, Pfizer, Sanofi, Merck and Co, GSK
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How does a company qualify as a BioPharma? (1)
If it makes 50% or more of its drug revenue from selling biologics and vaccines.
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What is the process of drug development? (8)
Discovery, Biological Activity, Formulation Development, Manufacture, Clinical Trials, Licensing, Marketing and Surveillance
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Outline Pre-clinical research. (4)
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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Other cards in this set

Card 2

Front

Top 5 Big Pharma? (5)

Back

Novartis, Pfizer, Sanofi, Merck and Co, GSK

Card 3

Front

How does a company qualify as a BioPharma? (1)

Back

Preview of the front of card 3

Card 4

Front

What is the process of drug development? (8)

Back

Preview of the front of card 4

Card 5

Front

Outline Pre-clinical research. (4)

Back

Preview of the front of card 5
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