Topics, Chapter 1, Introduction to Drugs; Discussion Topics. Learning Objective(s). 1a. Students’ answers should include the following: Women are not good candidates for phase I studies because the chemicals may exert unknown and harmful effects on a woman’s ova, and too much risk is involved in taking a drug that might destroy or alter the ova. Women do not make new ova after birth. Answers to discussion topics ; Men produce sperm daily, so there is less potential for complete destruction or alteration of the sperm. Women who elect to participate in phase 1 studies have to be informed of the potential risk and must sign a consent outlining the possible effects.
1b. Students’ answers should include the following: The Food and Drug Administration (FDA) is an agency of the U.S. Department of Health and Human Services that regulates the development and sale of drugs. Answers to discussion topics; FDA-regulated tests are designed to ensure the safety and reliability of any drug approved in this country. Before receiving final FDA approval to be marketed to the public, drugs must pass through preclinical trials and phase I, II, and III studies.
The FDA is involved in each stage of the study. Students’ answers should include the following: Brand name: name given to the drug by the manufacturer. Answers to discussion topics ; Generic name: chemical name of the drug listed in the national formulary. Drug dose and sometimes the route will be listed. Lot number: specific drug batch where the drug was produced; important for recall information. Expiration date: the date after which the drug should no longer be used. Students’ answers should include the following. Answers to discussion topics; Generic drugs are produced more cheaply than the brand-name drugs. For example, the binders used in a generic drug might not be the same as those used in the brand-name product.