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Additional resources for Katzung & Trevor's Pharmacology Examination and Board Review (10th Edition)

Sample text

Because of the urgent need for new agents, anticancer drugs and anti-HIV drugs require less evidence of safety than do drugs used in treatment of less threatening diseases. Urgently needed drugs are often investigated and approved on an accelerated schedule. A. Acute Toxicity Acute toxicity studies are required for all new drugs. These studies involve administration of incrementing doses of the agent up to the lethal level in at least 2 species (eg, 1 rodent and 1 nonrodent). 41 42 PART I Basic Principles High-Yield Terms to Learn Mutagenic An effect on the inheritable characteristics of a cell or organism—a mutation in the DNA; usually tested in microorganisms with the Ames test Carcinogenic An effect of inducing malignant characteristics Teratogenic An effect on the in utero development of an organism resulting in abnormal structure or function; not generally heritable Placebo An inactive “dummy” medication made up to resemble the active investigational formulation as much as possible but lacking therapeutic effect Single-blind study A clinical trial in which the investigators—but not the subjects—know which subjects are receiving active drug and which are receiving placebos Double-blind study A clinical trial in which neither the subjects nor the investigators know which subjects are receiving placebos; the code is held by a third party IND Investigational New Drug Exemption; an application for FDA approval to carry out new drug trials in humans; requires animal data NDA New Drug Application; seeks FDA approval to market a new drug for ordinary clinical use.

A) Cimetidine (B) Ethanol (C) Ketoconazole (D) Procainamide (E) Quinidine (F) Ritonavir (G) Succinylcholine (H) Verapamil 8. Which of the following drugs has higher first-pass metabolism in men than in women? (A) Cimetidine (B) Ethanol (C) Ketoconazole (D) Procainamide (E) Quinidine (F) Ritonavir (G) Succinylcholine (H) Verapamil 9. Which of the following drugs is an established inhibitor of P-glycoprotein (P-gp) drug transporters? (A) Cimetidine (B) Ethanol (C) Ketoconazole (D) Procainamide (E) Quinidine (F) Ritonavir (G) Succinylcholine (H) Verapamil 10.

The half-life determines the rate at which blood concentration rises during a constant infusion and falls after administration is stopped (Figure 3–3). The effect of a drug at 87–90% of its steady-state concentration is clinically indistinguishable from the steady-state effect; thus, 3–4 half-lives of dosing at a constant rate are considered adequate to produce the effect to be expected at steady state with a specified rate of chronic dosing. 25 units/h Time (h) FIGURE 3–2 often flow-limited. For such a drug, the total clearance from the body is a function of blood flow through the eliminating organ and is limited by the blood flow to that organ.

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