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8 Cards in this Set
- Front
- Back
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What stages occur in development before clinical testing?
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in vitro - cell culture
and in vivo - animal testing |
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What is an IND? NDA?
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Investigational New Drug (patented)
New Drug Approval (approved) |
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When are Pharmacokinetic & toxicological profile established?
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pre-clinical
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How many phases of clinical trial are there?
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4 (3 are pre-approval)
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what is tested in Phase I?
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tolerability, pharmacokinetics/dynamics
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what occurs in Phase II?
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patients tested (not volunteers)
effectiveness, dosage, safety |
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what occurs in Phase III?
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1,000-3,000
compared to placebo (RCT) compared to gold standard |
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what occurs in Phase IV?
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[post-approval]
new formulations identify best patients (recall where tested vs. where needed) safety assessment |
