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30 Cards in this Set
- Front
- Back
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How many compounds synthesized make it to clinical trials?
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5out of 4000
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How many drugs that enter clinical trials actually make it to the market?
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1out of 5
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Hw many years are needed to market a drug?
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15-20 years
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How much avg $is spent on marketing a new drug?
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$800 million
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FDA makes the final decision on whether a drug makes it or not... What is this based on (three things)
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Scientific, Accurate, and complete information
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The FDA approves how many new molecular entities per month?
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2
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What is the major reason for all of the trials/hassles that drug companies have to go thru?
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The history of human tragedy
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What act was passed in 1848? What did it require?
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Import drug act
Inspection/detention/destruction of imported drugs |
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What act was passed that required standards for strength and purity?
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Pre food and drug act of 1906
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Which act prohibited false therapeutic claims?
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Sherley amendment law of 1912 (after us vs Sullivan)
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When was the NDAfirst required?
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1938 fdca act
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When the NDA was first developed, the FDA had 60 days to respond, and if they didn't it could be considered approved. When did this change?
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The Kefauver-Harris drug amendment of 1962 (formal approval from FDA was approved)
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An experiment where a non-marketed drug is administered to human subjects
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Clinical investigation
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What is an INDA?
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Investigational NDA ( submitted to the FDA for approval to start testing in humans)
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An individual that initiates and conducts a clinical investigation (file the IND and oversees the use of the drug in humans)
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Sponsor/investigator
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When was the NDAfirst required?
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1938 fdca act
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When the NDA was first developed, the FDA had 60 days to respond, and if they didn't it could be considered approved. When did this change?
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The Kefauver-Harris drug amendment of 1962 (formal approval from FDA was approved)
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An experiment where a non-marketed drug is administered to human subjects
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Clinical investigation
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What is an INDA?
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Investigational NDA ( submitted to the FDA for approval to start testing in humans)
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An individual that initiates and conducts a clinical investigation (file the IND and oversees the use of the drug in humans)
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Sponsor/investigator
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When was the NDAfirst required?
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1938 fdca act
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When the NDA was first developed, the FDA had 60 days to respond, and if they didn't it could be considered approved. When did this change?
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The Kefauver-Harris drug amendment of 1962 (formal approval from FDA was approved)
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An experiment where a non-marketed drug is administered to human subjects
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Clinical investigation
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What is an INDA?
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Investigational NDA ( submitted to the FDA for approval to start testing in humans)
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An individual that initiates and conducts a clinical investigation (file the IND and oversees the use of the drug in humans)
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Sponsor/investigator
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What constitutes a "rare disease"?
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If it affects less than 200,000 ppl in the us
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Out the following in order regarding to "the approach to drug development"
Synthesis of compounds Preclinical testing Disease mechanisms Diseases |
Disease--> disease mechanisms --> synthesis of compounds--> preclinical testing
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What is step 1 in the drug approval process?
What does it aim to determine? What is the length of the study? What is the primary interest? |
Preclinical trials
Animals in vivo & cells in vitro Determines PHARMACOLOGICAL PROFILE determines ACUTE and SUBACUTE TOXICITY length of study = 14-90 days Primary interest = safety |
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What is step 2 in the drug approvals process?
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Submitting the INDA (30 days or clinical hold)
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What is step 3 in the drug approval process?
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Clinical research (phases 1-3)
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