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Lecture 3
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HC3 van Clinical trials and clinical development
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Lecture 3 DinsdagLifecycle of a drug
Aim drug development process
Preclinical work
Labanimals (at least 2 types)
Where will the molecule be working and how does this fit
Patent request -> during preclinical
-Obtaining marketing authorization application (MAA)
-Safe
-Efficacious
-Clean and reproducible manufacturing
-Sell on market
Figure 1 Drug development process
The drug development process is:
-Complex
-Laws and regulation
-Many desciplines/departments involved
-Technical
-Expensive
-Full of risks
-Short period for Return on Investment (ROI)
However, getting to the market is
Complex laws and regulations, many disciplines/departments involved, technical
Expensive
Full of risks
ROI is short
NDA is de MAA of the FDA
Trial cost
, -Drug development takes up to 20 years, patent life is short
-10.000 compounds tested to get 1 on the market
- 800M-1,5B per marketed drug
-1,2M per day marketing delay
- 1 in 4 recoups its own development cost
-1 in 100 is blockbuster (>1Bn per year sales)
Figure 2 Drug Development time
Figure 3 Drug development time
Consequences increased cost
-Products licensing in/out
-Cooperative research
-Co-development
-Co-marketing
-Mergers & Acquisitions
Drug Discovery
-Identification of target
-New Chemical Entity (NCE)
-Selection based on
-Stability of NCE
-Pharmacological and metabolic characteristics
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