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9 Cards in this Set
- Front
- Back
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Put the following in the correct order:
Clinical testing Animal testing Marketing In vitro studies |
1) In vitro studies
2) Animal testing 3) Clincial testing 4) Marketing |
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How many phases comprise "Clinical Testing" process?
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3 phases
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In the drug development process, what is assessed in the "Animal Testing" process?
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drug efficacy
drug selectivity drug mechanism |
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In the drug development process, what is assessed in the "Clincal Testing" process?
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drug metabolism
drug safety |
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How many years lapse between IND application and NDA?
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4-5 years
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Put the following in order:
Clinical phase Post-marketing Pre-clinical phase New Drug Application |
1. Pre-Clinical
2. Clinical 3. New Drug Application 4. Post-marketing |
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Discovery, screening, and safety testing occur in which of the following phases?
Clinical Pre-Clinical New Drug Application |
Pre-clinical
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What are potential confounding factors in the clinical testing phase?
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1. variability in natural history of the disease
2. presence of other medical problems in the subject 3. potential biases |
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What is MedWatch?
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FDA program for voluntary reporting of adverse events, product problems and product use errors
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