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Which of the following statements by nursing students indicates an understanding of the preclinical research stage of drug development?

  1. Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.

  2. Preclinical research results are always inconclusive.

  3. The FDA is responsible for extensive testing for safety before the pharmaceutical company can begin the preclinical research stage of development.

  4. The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans.

The correct answer is: Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.

The correct answer is A. This statement accurately reflects the purpose and outcomes often seen in the preclinical research stage of drug development. In the preclinical stage, drugs are tested extensively in laboratory and animal studies to evaluate their safety and efficacy before advancing to clinical trials involving human subjects. It is common for a significant number of drugs to be eliminated during this stage due to findings of toxicity or lack of effectiveness, which supports the statement that most drugs do not proceed past the preclinical stage for these reasons. Options B, C, and D are incorrect because preclinical research results may vary in conclusiveness, the FDA does not conduct preclinical research but oversees the process, and while animal testing is a critical component of the preclinical stage, it is conducted to assess potential harm to humans rather than to cause harm intentionally.