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Intro to Pharm 411
Stack 1
| Question | Answer |
|---|---|
| Passed to protect the public from adulterated or mislabeled drugs | Pure Food and Drug Act 1906 |
| Drug company required to list if 1 of 11 dangerous and perhaps addicting drugs | Pure Food and Drug Act 1906 |
| False and misleading clains about curative properties of the drug not allowed | Pure Food and Drug Act 1906 |
| Only drugs sold in interstate commerce covered | Pure Food and Drug Act 1906 |
| Designated th US Pharmacopoeia and National Formulary as official standards | Pure Food and Drug Act 1906 |
| Prohibited fraudulent therapeutic claims | Sherley Amendment 1912 |
| Drug manufacturers must test for harmful effects | Food Drug and Cosmetic Act 1938 |
| Drug labels must be accurate and complete | Food Drug and Cosmetic Act 1938 |
| Specified how Rx drugs can be ordered and dispensed | Durham-Humphrey Amendment 1952 |
| Required proof of both safety and efficacy prior to approval | Kefauver-Harris Amendment 1962 |
| Permitted generic versions of drugs initially marketed from 1938-1962 | Kefauver-Harris Amendment 1962 |
| 5 yrs of additional patent time for pioneer drugs | Drug Price Competition and Patent Term Restoration Act of 1984 |
| Periods of market exclusivity to develop new indications, dosage forms, dosage regimens | Drug Price Competition and Patent Term Restoration Act of 1984 |
| Generics could be approved for drugs introduced after 1962 with an abbreviated review process | Drug Price Competition and Patent Term Restoration Act of 1984 |
| Same active ingredients, dosage form, strength, route | Pharmaceutical Equivalence |
| May differ in shape, scoring, excipients | Pharmaceutical Equivalence |
| Rate and extent of abs aren't significantly different from pioneer. | Bioequivalence |
| Must lie within 80-125% of the pioneer | Bioequivalence |
| High abuse potential, no accepted med use, research protocol only, may lead to severe dependence | Schedule I |
| High abuse potential, accepted medical uses, may lead to severe dependence, written Rx, no refills | Schedule II |
| Less abuse potential, accepted med uses, low/moderate physical dependence, high psychological dependence, written or oral Rx required, 6 mos of refills | Schedule III |
| Lower abuse potential, accepted med uses, limited dependence, written or oral Rx required, 6 mos of refills | Schedule IV |
| Lower abuse potential, accepted med uses, limited dependence, may or may not require Rx | Schedule V |
| Initial pharmacologic evaluation, small number of normal volunteers | Phase I of FDA Approval Process |
| Limited controlled evaluation | Phase II FDA approval process |
| Increasing doses, pts with diseases | Phase II FDA approval process |
| Effectiveness and side effects tested | Phase II FDA approval process |
| Extended clinical evaluation | Phase III FDA approval process |
| Determination of clinical effectiveness | Phase III FDA approval process |
| Drug safety determination | Phase III FDA approval process |
| Establishing safe/effective dose | Phase III FDA approval process |
| Drug binds to receptor and produces the same type of response. Intrinsic activity equals 1. | Agonism |
| Drug interacts with receptor and produces a less intense response. Intrinsic activite btwn 0 and 1 | Partial agonism |
| Drug binds to a receptor that prevents a response to an agonist | Antagonism |
| Agonist and antagonist both trying to bind to the same receptor | Competitive antagonism |
| Binding of antagonist to one receptor prevents agonist from binding to/activating another receptor. Agonist must not be bound for antagonist to bind. | Noncompetitive antagonism |
| 2 seperate receptors, opposite effects | Effect Antagonism |
| Same receptor | Pharmacologic Antagonism |
| Pill disintegrates into big chunks, still can't cross biologic membrane. Dissolution-disolved in fluid, can move across membrane | Pharmaceutical Phase |
| Absorption, movement of drug molecules into the body | Pharmacokinetic Phase |
| Nature of activity of drug linked to blood concentration | Pharmacodynamic Phase |
| Variables that affect drug absorption | Nature of absorbing surface, surface area, blood flow to site of administration, solubility of the drug, dosage form |
| #1 site of oral drug absorption | When taken by mouth (enteral), small intestine |
| 3 things needed for most drug absorption | Huge surface area, rich blood supply, basic pH |
| 1 drug increases or decreases plasma conc. of another drug | Pharmacokinetic Interactions |
| 1 drug induces change in response to another drug (toxicity) without altering kinetics | Pharmacodynamic Interactions |
| Physical/chemical incompatabilities | Pharmaceutical Interactions |
| 3 properties of important object drugs | have narrow therapeutic range, are metabolized by hepatic mixed function oxidases, are used chronically |
| Altered absorption interaction-Cholestyramine | binds to many drugs |
| Altered absorption interaction-Ketoconazole | drugs or foods which decrease gastric acid |
| Altered absorption interaction-Tetracycline | binds to divalent or trivalent cations (Calcium) |
| Time course of enzyme inducers | slow onset, slow offset |
| Time course of enzyme inhibitors | Rapid onset, rapid offset (usually w/in 24 hrs) |
| Effects of enzyme inhibition | Toxicity, more likely to result in pt harm than induction |
Created by:
lbreimeir
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