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Pharm Lect 1
| Question | Answer |
|---|---|
| Generic drug name | Official name assigned by USANC. Public property. First letter is always lower case. |
| Chemical drug name | describes the atomic/molecular structure of the drug. |
| Trade drug name | "Brand name" that is used by a specific company. Pharma company owns the name. First letter always CAPITALIZED. **Copywrite trade names are available as generics after about 10 yrs |
| Difference between prescription and OTC Drugs | Prescription drugs are unsafe without medical supervision. OTCs are meet higher safety standards for self-medication. |
| Difference between a Drug and a Formulation | Drug: any chemical that affects living systems. Formulations: (pills, tablets, capsules) do contain the drug substance (active ingredient), but also contain chemical impurities and excipients (inactive substances) |
| General criteria of a controlled substance | **Organized into 5 schedules (1 being the most serious) 1.Abuse potential. 2.Medical Use. 3.Dependence potential. |
| Phases of a clincial trial for new drug development | 1.Phase 1: safety & pharmocokinetics (Body's utilization of drug). 2.Phase 2: safety & efficacy. 3.Phase 3: safety & efficacy. 4.Phase 4: post-marketing studies |
| Phase 1 clinical trial | First use in humans. Lasts 6months-1yr. 20-100 HEALTHY volunteers. |
| Phase 2 clinical trial | ASSESING safety & efficacy: Optimal dose and dose schedule. Lasts 1-2yrs. 100-200 DISEASED patients. |
| Phase 3 clinical trial | PROVING safety & efficacy. Lasts 3yrs. 1000-6000 patients. |
| Phase 4 clincial trial | Post-Approval safety monitoring: once the drug is in the patient population. **Detects rare and long-term adverse effects. |
| Orphan Drug | drugs that target rare diseases affecting < 200,000 people. Companies are encourage to develope these with tax reductions and marketing exclusivity. **Not much interest due to unprofitable market. |
| Institutional Review Board(IRB) | Reviews propoesed clinical studies for: 1.scientific merit. 2.Ethical acceptability. 3.Protection of patient. 4.Proper consent. |
| Informed Consent Document | (In Lay terms) 1.Explains purpose/procedures of the research. 2.Risks & Benefits. 3.States available alternative procedures. 4.Confidentiality of records. 5.Compensation/treatment if injured. 6.Who to contact. 7.PARTICIPATION IS VOLUNTARY!! |
| Routes of drug administration: Oral | Advantages: (Most common), Safest & most economical. Absorption: Slow. Disadvan: GI irritation, First pass metabolism, Formulation must dissolve and survive stomach acid, Requires patient cooperation. |
| First Pass Effect (First pass metabolism) | drug metabolism whereby the concentration of a drug is greatly reduced before it reaches the systemic circulation. |
| Routes of drug administration: Rectal | Advantages: Used with pts that are vomitting/unable to swallow. Reduced first-pass (inferior rectal venous drain directly into systemic circulation, by-pass the liver). Absorption: slow/irregular Disadvan: Uncomfortable |
| Routes of drug administration: Buccal and Sublingual | Advantages: Higher bioavailability, less first-pass effect (avoids GI and liver), best for small potent dose. Absorption: Rapid. Disadvantages: inconvenient |
| Routes of drug administration: Transdermal | Absorption: Slow and dependent on variables Disadvantages: must be extremely lipid soluble, can alter pharmacokinetics, |
| Routes of drug administration: Topical | Advantages: treats without systemic exposure. Absorption: NONE (no systemic exposure) Disadvantages: must be lipid-soluble |
| Routes of drug administration: Subcutaneous (SC) | Adv: Self-administered, no first pass effect. Absorption: Slow/constant/complete (simple diffusion). Disadv: Must have good circulation at injection site, can cause local tissue damage, small injection volume limits use. |
| Routes of drug administration: Intramuscular (IM) | Adv: Can give a larger volume than SC, increased bioavailability, no first-pass effect. Absorption: rapid (enhance by exercise and aqueous solution) Disadv: Tissue irritation. **Deeper into tissue than SC, faster than SC due to > BL flow. |
| Routes of drug administration: Intravenous (IV) | Adv: Quickest onset of action, 100% bioavailability, controllable. Absorption: FASTEST (no initial absorption step). Disadv: MOST DANGEROUS (bypasses all defenses), infections, toxicity. **Central IV (SVC) is better than Peripheral IV |
| Routes of drug administration: Inhalation | Adv: no first-pass effect, can be local or systemic. Absorption: rapid (quick to reach the brain) Disadv: limited to gas & small particles, most addictive, trouble with self administration. |
| Routes of drug administration: Intrathecal | **Directly into CSF** Adv: treats acute CNS infections, spinal anesthesia, local/rapid effects on meninges. Absorption: rapid. Disadv: dangerous. |
| Bioavailability | fraction of an administered dose of unchanged drug that reaches the systemic circulation. **one of the principal pharmacokinetic properties of drugs |
| Excipient | pharmacologically inactive substance used as a carrier for the active ingredients (drug) of a medication |
| Pharmacodynamics Vs Pharmacokinetics | Dynamics: Actions of the drug on the body (post-receptor effects). Kinetics: Actions of the body on the drug (ADME: absorption, distribution, metabolism, excretion) |
Created by:
WeeG
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