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Examination 1

A new drug for the treatment of type 2 diabetes is under development. Phases 1 and 2 trials have been concluded and phase 3 trials are planned. Phase 2 clinical trials typically involve

(A) Collection of data regarding late-appearing toxicities from patients previously studied in phase 1 trials

(B) Double-blind, closely monitored evaluation of the new drug in hundreds of patients with the target disease by specialists in academic centers

(C) Evaluation of the new drug under conditions of actual use in 1000–5000 patients with the target disease

(D) Measurement of the pharmacokinetics of the new drug in normal volunteers

(E) Post-marketing surveillance of drug toxicities

B (1) Phase 1 trials are carried out in a small number of normal volunteers. Phase 3 trials are carried out under the conditions of proposed use in (usually) several thousand patients. Phase 2 trials are carried out (usually) in academic centers under close monitoring*.

A patient is admitted to the emergency department with hypertension and intermittent seizures. Evidence suggests he is suffering from a drug overdose. The identity of the drug is unknown, but it is observed that when the urine pH is alkaline, the renal clearance of the drug is much greater than when the urine pH is acidic. The drug is probably a

(A) Strong acid

(B) Weak acid

(C) Nonelectrolyte

(D) Weak base

(E) Strong base

B (1) According to the Henderson-Hasselbalch principle (see Chapter 1), weak acids are less protonated (and more charged) in alkaline media, and weak bases are more protonated (and more charged) in acidic media. Strong acids and bases are fully ionized at any pH. Since the clearance of the unknown drug is greater in alkaline urine, the drug must be a weak acid.

A 57-year-old man is in the coronary care unit after an acute myocardial infarction. He has developed signs of heart failure with reduced ejection fraction (HFrEF) of rapidly increasing severity and several drugs have been suggested. Furosemide, dobutamine, and digoxin can each

(A) Decrease conduction velocity in the atrioventricular node

(B) Decrease venous return

(C) Reduce pulmonary edema

(D) Increase peripheral vascular resistance

(E) Increase the amount ...

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