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Definition
an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease
-or to affect the structure of any function of the human body, but does not include intermediates used in the synthesis of such ingredient |
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| single entity that you can isolate |
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| manufacturer can only make label claim if |
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| nutritional and dietary supplements |
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Definition
-not formally regulated by FDA but some authority under DSHEA
-focuses on safety not effectiveness
-not classified as drugs
-don't treat diseases, but "support" function |
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| Egyptian clay tablets contained |
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| medicinal recipes (prescription) |
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| Hippocrates, Galen, Paracelsus |
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Definition
-introduced scientific method
-used to understand physiology and medicine |
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| cultivation and isolation of medicinal agents from plants by natural product chemists |
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| Dietary Supplement Health and Education Act of 1994 |
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Definition
-from cinchona plant
-1830s |
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Definition
-US Pharmacopeia
-1820
-drug product compendia or collection of standard isolation and manufacturing methods
-not affiliated with FDA |
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| drugs produced in the lab became a recognized source of new drugs by |
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| aspirin produced in the lab in |
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| used to determine nature of pharmacological effects |
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Definition
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Definition
-structure-activity relationships
-relationship between and chemical and its biological activity (pharmacological effect) |
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Definition
| group of atoms in a molecule responsible for drugs actions |
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Definition
| absorption, distribution, metabolism, elimination |
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| determination of viable drug candidates |
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Definition
-simulation and modeling programs
-some can put success rate up to 1/10,000 |
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Term
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Definition
-development of drug delivery systems (formulations)
-testing in vitro (cell culture) and in vivo (whole animal)
-INDA filed with FDA
-not required for bioequivalent drugs
-coded drug names are given generic name |
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Definition
| -Investigational New Drug Application |
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Definition
| safety, efficacy, and product quality |
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Definition
-US Adopted Names
-published by USP,AMA, APhA
-generic name stems, prefixes,suffixes |
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Definition
| HMG-CoA inhibitor antihyperlipidemics |
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Term
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Definition
| sulfonamide-derived antimicrobial drugs |
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Definition
| anti-inflammatory analgesic agents |
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Definition
| ACE inhibitor antihypertensives |
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Term
| review look alike and sound alike products |
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Definition
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Definition
-formulation development and product stability
-testing in humans
-FDA approves for a specific use
-NDA filed with FDA |
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Definition
-20-100 healthy subjects
-low dose
-safety |
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Definition
-100-300 subjects
-minimal disease progression
-increasing dose
-effectiveness, side effects, toxicity |
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Definition
-200-3000 subjects
-disease progression
-multiple dosages
-effectiveness, dosage, risk-benefit |
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| not required for generic drugs that are bioequivalent |
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Definition
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Definition
-new drug application
-generic drugs required to file abbreviated NDA |
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| post marketing evaluation |
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Definition
-Phase IV
-larger number of patients
-side effects with low probability
-new formulations |
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Definition
| toxicity, manufacturing defect, contamination, mislabeling |
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