Term
Which of the following is the correct description of an "orphan drug"?
1. Drug that is safe and effective for use by general public without seeking treatment by health care professional.
2. Drug developed to treat rare medical condition that is easiest to gain marketing approval for
3. Drugs that have same, dosage, indications, contraindications and RoA as prescription drugs
4. Drug not yet approved by FDA, but under clinical trial |
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Definition
2.
1. over the counter drug
3. generic drug
4. investigational new drug (IND)- needs IND and FDA approval. |
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Term
What drug properties do each of the following descriptions refer to.
1. Degree to which a set dose produces the desired effect in relation to adverse effects (varying dose may change this).
2. Measure of activity expressed in terms of amount required to produce an effect of given intensity
3. Capacity of a drug to produce maximum therapeutic response under ideal conditions
4. Capacity of a drug to produce maximum therapeutic response under real-world conditions |
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Definition
1. Selectivity
2. Potency
3. Efficacy
4. Effectiveness |
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Term
| Distinguish between Type A and Type B adverse drug reactions. |
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Definition
Both are harm directly caused by drug at normal doses, during normal use.
1) Type A reactions are predictable, common and related to pharmacological actions of drug that may occur in any patient.
** Examples include intolerance or side effects
2) Type B reactions are unpredictable, uncommon and usually not related to pharmacological actions of drug (ONLY in susceptible individuals) |
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Term
What is the therapeutic index (or ratio) for a given drug?
What would a ratio of 2 mean? |
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Definition
1. Comparison of amount of agent that causes therapeutic effect to the amount that causes death.
Ratio of toxic dose/therapeutic dose (TD50/ED50)
2. A toxic dose of "2" would mean that it takes twice as much of the drug to kill 50% of the population than it does to achieve desired therapeutic effect in 50% of the population |
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Term
How does the "therapeutic index" differ from the "standard safety factor"?
When would you use SSF vs. TI? |
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Definition
1. Therapeutic index refers to ratio of TD50/ED50
2. SSF refers to TD1/ED99
Use SSF when quantal dose-response curves for the desired and toxic effects are not parallel. |
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Term
| Distinguish between the 4 phases of a usual clinical trial. |
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Definition
1. Effects of new drug as function of dosage are examined in 20-100 healthy people (SAFETY of dose-escalation and initial pharmacokinetics)
2. 100-200 patients with targeted disease to determine efficacy (proof-of-concept)- HIGHEST FAILURE RATE
3. >1000 patients with targeted disease (FDA approval is determined by 1 or more phase-3 trails based upon ONLY efficacy and safety).
4. Post-marketting surveillance (actual safety determination) |
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Term
| True or False: It is legal for physicians to prescribe drugs to people in a way not approved by the FDA. |
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Definition
| TRUE! Off-label practice is actually legal |
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Term
True or False:
Variability in pharmacological response is greater with drugs that are excreted unchanged in the urine than in those that are metabolized. |
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Definition
False!
If they are metabolized, they are subject to pharmacokinetic differences in absorption, tissue structure, body size, ect. |
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Term
Which of the following is not a major cause for variation in drug responsiveness between patients?
1. Compliance.
2. Dose
3. Diet
4. Patient pathology
5. Drug-drug interactions |
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Definition
| 3. Diet may have an effect, but is not considered a major player. |
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Term
| When can pharmacokinetic drug interactions take place? |
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Definition
4 places
1. Absorption
2. Distribution
3. Metabolism
4. Elimination |
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Term
| Distinguish between "synergism" and "potentiation" in terms of drug-drug interactions. |
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Definition
Pharmacodynamic interactions
1. Synergism occurs when effect of 2 drugs together is greater than sum of parts (vs. Additive)
2. Potentiation occurs when one drug is inactive on its own, but increases the action of a second drug. |
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Term
| What is the difference between physiological and chemical antagonism in drug-drug interactions? |
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Definition
1) Physiological occurs when two drugs exert opposite biological effects (raise and lower BP simultaneously)
2) Chemical occurs when two drugs form inactive complex. |
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