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21 Cards in this Set
- Front
- Back
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Define Pharmacology
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The study of interaction of chemicals (besides food) with living systems
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Define Pharmacodynamics
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Mechanisms of drug actions
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Define Pharmacokinetics
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Absorption, Distribution, Metabolism, and Elimination of drugs
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Define Chemotherapy
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The use of drugs, which ideally have little effect on the host (patient) but destroy or retard the growth of invading cells and organisms.
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Pure Food and Drug Act
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1906 - Concerned with purity
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Food, Drug, and Cosmetics Act
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1938 - Concerned with labeling and safety. Put FDA (which was established in 1930) in charge of enforcement and required the New Drug Application before marketing
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Harris - Kefauver Amendment
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1962 - Required proof of efficacy. Required Investigational New Drug Application prior to clinical testing.
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FDA Modernization Act
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1997 - Set Application fees and made improvements to expedite drug approvals
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Drug Development Time and Costs
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Takes about 12-14 years to get to market. Average cost is 2 billion with 65% to trials, 23% to discovery, and 12% to toxicology studies. Costs are rising while productivity is declining.
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Development Process
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Therapeutic objective and market analysis -> Lead finding (molecular modeling or natural screening or novel chemicals) -> pharm eval (receptor binding, animal models) -> prelim assessment (toxicology, scale up potential, clinical costs) -> business decision to develop drug
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Investigational New Drug Application Requirements
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Chemical/biological activities, dosage form specifications, quality controls, description of facilities and personnel (including investigator qualifications), and specific protocols (must be controlled experiment)
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Clinical Trials: Preclinical
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Develop a pharmacological profile
Determine the acute toxicity in at least two species Conduct short-term toxicity studies ranging from 2 weeks to 3 months |
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Clinical Trials: Phase I
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First human exposure to drug
6-9 months 20-100 healthy volunteers Determines how best to administer, verifies safety and side effects, and evaluates drug kinetics |
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Clinical Trials: Phase II
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6 months - 3 years
30-40 diseased and health volunteers Test patient treatment response (20% = successful), establish dosing range (determines common short-term side effects and risks), and start initial long-term toxicity studies |
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Clinical Trials: Phase III
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1-4 years
100-1000 diseased volunteers Determines clinical benefits and offers expanded evaluations of effectiveness and safety to determine risk v. benefit |
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New Drug Application Requirements
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Includes completed results from Phase I-III of clinical trials, long-term animal toxicity studies, and the effects of the drug on fertility, reproduction, and young animals
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Follow-up Testing
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1-2 years of close scrutiny gathering additional safety info or test on additional conditions (IIIb) or expanding to broader patient populations (IV). Post-market studies look at new age groups/patient types to focus on previously unknown side effects or to assure safety/efficacy
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Good Laboratory Practices (GLP)
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1979 - Regulatory guidelines followed by validated labs to ensure each study step is valid
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Generic v. Trade Drug names?
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Generic - assigned universal name agreed upon by the AMA Council of Drugs and the WHO
Trade - name given (and owned by) the manufacturing company |
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Accelerated Development/Review
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1992 - specialized mechanism for speeding the development of drugs that promise significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists
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"Parallel Track" Policy
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1990 - patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising
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