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20 Cards in this Set
- Front
- Back
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List the stages of the drug approval process
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1) Preclinical testing to determine toxicity and pharmacokinetics
2) Submit IND 3) Conduct Clinical Trials (I,II,III) 4) Submit NDA 5) Receive action letter (approved, approvable or not approvable) 6) If approved, then conduct Phase IV studies. If approvable or not approvable, respond to action letter |
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How long does it take to bring a drug to market?
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In total, between 7 and 8 years.
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What is the current estimate of how much money it takes to bring a drug to market?
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1.7 billion dollars
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On whom is preclinical testing done?
Where is the data submitted? |
In vitro or on animals to get a pharmacological profile
In an INDA to the FDA's Center for Drug Evaluation and Research (CDER) |
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What is the purpose of the IND?
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To show that it would be reasonable to pursue human research.
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What is the purpose of Phase I trials?
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To determine safety and toxicity of the drug
Study pharmacokinetics Establish preferred Route of Administration |
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How do these trials work?
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20-80 healthy volunteers
You start with a low dose and increase as safety data comes in Typically lasts 6 months to 1 year |
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What is the purpose of Phase II trials?
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To evaluate the efficacy of the drug
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How do they work?
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Enroll 100-200 people who have the condition
Typically lasts 2 years |
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What is the purpose of Phase III trials?
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To further assess drug safety and efficacy
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How do these trials work?
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Enroll 600-1000 patients
Generally lasts 3 years |
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What is the purpose of the NDA?
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To allow the FDA CDER reviewer to establish that the drug safety and efficacy benefits outweigh the risks, appropriateness for proposed labeling, and adequacy of manufacturing process to preserve drug identity, strength, quality and purity
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How long does FDA review of the NDA take?
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8-15 months
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What does the NDA tell the FDA?
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Study results (preclinical, clinical)
Manufacturing information (quality assurance) Prior experience with drug (foreign clinical testing, published reports) Package insert |
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What are the 3 NDA Review Classifications?
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P: Priority Review Drug - Drug appears to represent an advance over available therapy (review within 6 months)
S: standard review drug - Drug appears to have therapeutic effect similar to those of an already marketed drug (review within 10 months) O: Orphan drug - Product that reats a rare disease affecting < 200,000 Americans |
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What are Phase IV trials?
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Studies conducted after the drug has been approved
To gain additional information about drug used for the approved indication such as dosing and safety in patient populations not previously studied Can identify potential new indications and adverse event reporting. |
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The Development and Approval of Vaccines is similar to that of drugs. Where is the data on a new vaccine submitted?
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Center for Biologics Evaluation and Research (CBER)
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Where are adverse reactions to vaccines reported?
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Vaccine Adverse Events Reporting System
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What are 5 pharmacist roles in the Drug Development Process?
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Serve on an Investigational Review Board
Serve as a study investigator Help prepare regulatory documentation Randomize patients to treatment arms Manage drug supply for studies |
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What is the Orphan Drug Act (1983)?
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Designation as an orphan drug provides incentives for development
Financial incentives - Market exclusivity for 7 years from approval date, Tax credits - 50% credit for money used to research and develop the drug, Grant funding up to 12 million annually |
