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13 Cards in this Set
- Front
- Back
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What is involved with Pre-clinical testing?
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in vitro testing
in vivo testing (animals) toxicology testing in animals |
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Why is an Investigational New Drug Approval significant?
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Companies submit these to the FDA after successful pre-clinical testing. If approved, clinical trials can begin!
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Name 4 requirements for a good clinical trial:
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Proper planning
Control groups double blind format randomization |
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What was the purpose of the Orphan Drug Act?
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development of products that demonstrate promise for diagnosis and/or treatment of rare diseases* or conditions
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Why was Congress motivated to pass the Orphan Drug Act?
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-many disease considered "rare"
-drugs unavailable for treatment -pharma companies not motivated to find cures due to inevitable financial loss -incentives needed for drug development -in public's best interest to do so |
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What defines a "rare" disease?
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-affects less than 200k in US
-affects more than 200k, but is not cost effective |
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Clinical Trial Phase 1
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-limited # of young healthy volunteers
-non-blinded, designed to collect pharmacokinetic date -extensive if only drug of its kind -real patients used if toxicity issues |
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Clinical Trial Phase II
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-for most drugs, 1st patient exposure
-safety & efficacy examined -final dosage form for further trials established |
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Clinical Trial Phase III
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-Limited or extensive based on Phase II results
-could have thousands involved |
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What is Phase IV of Clinical Trials?
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-known as Post-marketing surveillance
-health professionals submit adverse rxn data to FDA -rare toxic rxns can be missed in phases I-III (phase IV important!) |
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Why would a drug produce effects during phase IV not seen during phases I-III?
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-heterogenuous patient pop.
-PCP supervision as opposed to specialists -dosage not monitored as closely -other drugs used = DD interactions |
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What was the result of the CAST clinical trial?
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CAST study demonstrated that despite their ability to suppress ventricular ectopy, the drugs actually increased the frequency of sudden cardiac death
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What was significant about the Tegenero clinical trial disaster?
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-despite adequate preclinical trials, 6 cases of severe adverse reactions in human volunteers
-one volunteer said consent was hard to read, and felt pressure to sign in 15 minutes |
