Knowledge Check Solutions
1) All of the above - This is the correct answer.
Modern approaches to testing for toxicity include in silico, in vitro, and improved (refined) animal testing.
2) Non-clinical laboratory studies - This is the correct answer.
Investigational New Drug Applications (IND) require clinical investigations. Before clinical investigations begin, a minimal battery of non-clinical laboratory studies must be completed.
3) Obtain information to design a more definitive Phase 2 clinical investigation - This is the correct answer.
The primary goal of a Phase 1 clinical investigation is to obtain information that is used to design more extensive, Phase 2 studies.
4) Phase 3 clinical investigation - This is the correct answer.
Determining the overall risk versus the benefit of a new pharmaceutical is part of Phase 3 clinical study. The risk versus benefit is one of the last steps in the drug evaluation process.
5) Cohort study - This is the correct answer.
The type of epidemiology study in which individuals are identified according to exposure and followed to determine subsequent disease risk is known as a cohort study. In a cohort study individuals are selected to be part of the group based on their exposure to a particular substance.
6) Retrospective cohort study - This is the correct answer.
This is known as a retrospective cohort study. As the name implies, retrospective cohorts are identified according to past exposure conditions and the follow-up study proceeds forward in time.
1) All of the above - This is the correct answer.
Modern approaches to testing for toxicity include in silico, in vitro, and improved (refined) animal testing.
2) Non-clinical laboratory studies - This is the correct answer.
Investigational New Drug Applications (IND) require clinical investigations. Before clinical investigations begin, a minimal battery of non-clinical laboratory studies must be completed.
3) Obtain information to design a more definitive Phase 2 clinical investigation - This is the correct answer.
The primary goal of a Phase 1 clinical investigation is to obtain information that is used to design more extensive, Phase 2 studies.
4) Phase 3 clinical investigation - This is the correct answer.
Determining the overall risk versus the benefit of a new pharmaceutical is part of Phase 3 clinical study. The risk versus benefit is one of the last steps in the drug evaluation process.
5) Cohort study - This is the correct answer.
The type of epidemiology study in which individuals are identified according to exposure and followed to determine subsequent disease risk is known as a cohort study. In a cohort study individuals are selected to be part of the group based on their exposure to a particular substance.
6) Retrospective cohort study - This is the correct answer.
This is known as a retrospective cohort study. As the name implies, retrospective cohorts are identified according to past exposure conditions and the follow-up study proceeds forward in time.