Which statements regarding the preclinical research stage of drug development are true?
1. Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.
2. At the end of the preclinical research stage, client variability is determined and potential drug-to-drug interactions are examined.
3. The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans.
4. Preclinical research results are always inconclusive.
5. The Food and Drug Administration (FDA) is responsible for extensive testing for safety before the pharmaceutical company can begin the preclinical research stage of development.
Correct Answer: 1,3,4
Rationale 1: Most drugs do not proceed past the preclinical research stage of development because they are found to be either too toxic or just ineffective.
Rationale 2: Client variability and potential drug-to-drug interactions are examined in Phase 3 of the clinical investigation process after Food and Drug Administration (FDA) approval.
Rationale 3: The preclinical stage of development involves extensive testing on human, microbial cells, and animals to determine drug action and to predict whether the drug will cause harm to humans.
Rationale 4: Because lab tests cannot accurately predict human response to a drug, these results are always inconclusive.
Rationale 5: This extensive testing is done by the pharmaceutical company in the preclinical research stage of drug development, not the FDA.
Global Rationale: The true statements include: most drugs do not proceed past the preclinical research stage of development because they are found to be either too toxic or just ineffective; the preclinical stage of developmentinvolves extensive testing on human, microbial cells, and animals to determine drug action and to predict whether the drug will cause harm to humans; and because lab tests cannot accurately predict human response to a drug, these results are always inconclusive. Client variability and potential drug-to-drug interactions are examined in Phase 3 of the clinical investigation process after Food and Drug Administration (FDA) approval. Extensive testing is done by the pharmaceutical company in the preclinical research stage of drug development, not the FDA.
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