Introduction to Pharmacology
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| What is an indication? | a specific use for a drug for which a pharmaceutical company receives approval from the FDA.
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| Physicians often use drugs for an "unapproved" or "off-label use." Explain some of the things they might be used for? | dosage, patient populations, indications, administration route that are not included in the FDA approved labeling
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| What are LEGEND drugs? | agents that require a prescrption by a licensed professional.
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| What are the 6 categories of drugs? | Prescription (Legend), Controlled, OTC, Orphan, Investigational, Dietary supplement
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| Which controlled substance has the highest abuse potential (referring to categorization)? | Schedule 1
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| what is the scale for controlled substances? | Schedule 1 (most addictive)--> Schedule 5 (least addictive)
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| What is the highest amount of OTC ibuprofen (in mg's)? Famotidine (histamine-2 rec blocker)? | 200mg; 10mg
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| what is an orphan drug? | intended to treat, diagnose, or prevent rare disease (affecting fewer than 200,000 ppl or where disease affecting over 200,000 won't generate a profit).
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| what is an investigational new drug (IND)? | a drug not yet approved by the FDA for distribution or use; can also apply to an existing drug undergoing IND propensity for new indication.
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| What are the requirements for dietary supplements? | they can advertise structure/function claims, but not treatment
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| What are the phases of drug development? | (1) Preclinical Research and Development (2) IND application (3) Clinical Research and Development (4) NDA (5) Post-Marketing Surveillance
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| what stage of drug apprval involves animal testing? what must be submitted to begin human clinical testing? | Animal testing occurs during preclinical research and development. Human testing begins after approval of IND application
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| During clinical research and development, what are phase 1 studies? | intended to define the inital parameters of toxicity, tolerable dosages, and general data; normally number of subjects is low; FDA ensures that subjects aren't exposed to unreasonable risks
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| what are phase 2 studies? | During clinical research and development, these studies are to determine effectiveness, adverse effects, and develop rational dosaging. Typically large numbers of subjects tested; FDA reviews scientific merit at this point.
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| What are phase 3 studies? | during clinical research and development, involve several thousand pts to document effectiveness for specific indications and clinical safety; FDA ensures that research content will likely lead to drug approval.
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| what are phase 4 studies, during clinical research and development? | this occurs after a drug has been put on the market and post-surveillance indicates that it needs to be recalled for further testing
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| If all 3 phases of the clinical research and development are successful, what is the next step? | all the date accumulated under the IND is compiled into an DNA and submitted for FDA review
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