Answers

1. D. There is always some degree of risk in clinical trials; the object is to minimize the risk to the patient. The primary consideration in any clinical trial is the welfare of the subject. The safety of the drug is one objective for certain clinical trials as is the efficacy of the drug in other trials.

2. A. Phase I studies are carried out in normal volunteers. The object of phase I studies is to determine the dose level at which signs of toxicity first appear. Phase II studies are carried out in patients in which the drug is designed to be effective in. It is conducted to determine efficacy and optimal dosage. Phase III studies are a continuation of phase II, but many more patients are involved. The purpose of phase III studies is to verify efficacy established earlier in phase II studies and to detect adverse effects that may not have surfaced in earlier studies. Phase IV studies are conducted when the drug has been approved and is being marketed. The purpose of these studies is to broaden the experience with the drug and to compare the new drug with other agents that are being used clinically.

3. C. John Jacob Abel occupied the first chair of a department of pharmacology in the United States. This was at the University of Michigan. Abel subsequently left Michigan to chair the first department of pharmacology at Johns Hopkins University. Claude Bernard was an early French physiologist and pharmacologist. Rudolph Bucheim established one of the first pharmacology laboratories at the University of Dorpat (Estonia). Oswald Schmiedeberg is considered the founder of pharmacology. He trained approximately 120 pupils from around the world, including the father of American pharmacology, John Jacob Abel.

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