Which statements regarding the preclinical research stage of drug development are true? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Standard Text: Select all that apply
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.
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 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: Most drugs do not proceed past the preclinical research stage of development because they are found to be either too toxic or just ineffective. 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. The preclinical stage involves extensive testing on human, microbial cells, and animals to determine drug action and to predict whether the drug will cause harm to humans. Because lab tests cannot accurately predict human response to a drug, these results are always inconclusive. This extensive testing is done by the pharmaceutical company in the preclinical research stage of drug development, not the FDA.
You might also like to view...
During admission to the facility, the nurse will look at factors that reduce the body's immune system. The 48 year old executive with diabetes would demonstrate which of the following risk factors? Standard Text: Select all that apply
1. Age 2. Stressors 3. Nutrition 4. Medications 5. Chronic diseases
The nurse is performing a vaginal exam on a female client and notes a frothy yellow–green discharge. The nurse would suspect the client is experiencing which of the following?
1. Trichomoniasis 2. Chlamydia 3. Vaginitis 4. Gonorrhea
The client arrives in the intensive care unit after a bronchoscopy. Which client assessment is the nurse's priority?
1. Gag reflex 2. Level of sedation 3. Circulatory status 4. Respiratory status
A community health nurse is preparing to assess a family. Which of the following characteristics would the nurse need to integrate into the assessment as universal? Select all that apply
A) The family members are stuck in one stage of development. B) Cultural values and rules C) Every family has structure. D) Every family is a small social system. E) No particular structure, as families are dynamic