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A bioequivalence test is the same as a clinical trial.
true or false?
Step by step
Solved in 2 steps
- State whether true or false A bioequivalence test is the same as a clinical trial.Manufacturers of self-contained test kits apply for and receive Food and Drug Administration (FDA) approval for their particular test to be on the Clinical Laboratory Improvement Amendment (CLIA) waived list. To find out if your particular brand of self-contained test kit is on the CLIA waived list, access an up-to-date listing at the FDA website(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm (Links to an external site.)) and use the key search term “Currently Waived Analytes” (be forewarned, though, that the list is very long) (Cited from Chap. 37). Research the link to the FDA to find your kit name on the list. Discuss the following questions: Why would it be important to have this kit listed here? Can a POL use kits that are not listed?What does the acronym TPA stand for and how is TPA used in diagnostic medicine? Explain briefly.
- Outline the general steps from initial drug discovery to IND filing. Add as much detail as you need and feel free to use flow charts, graphics, visuals, as long as is made by you alone and not directly copied-pasted from another source. If an IND is cleared to proceed by the US-FDA, what is the single most important goal of a first-in-human (FIH) clinical trial?Industry-sponsored clinical trials are legally required to only use clinical outcome measures that have been prospectively validated. True or false?Read the following statements. Interpret the following results and give the rationale. a. Given that the limit test is valid, one replicate of Solution A gave a positive result and the other replicate is negative. Interpretation: Rationale: Disposition:
- List at least three different tests that fall in the direct identification category.Should patients have the right to decline testing?Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power. Characteristics or indications that subjects must have in order to participate in the clinical trial A. DSMB The probability of detecting a meaningful difference, or effect, if one were to occur B. CRO Prospectively identified and quantifiable parameters that a study is designed to meet C. Inclusion criteria An independent organization that provides management services for clinical trials D. CEC An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study E. Endpoints An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor F. Power An independent body that…
- Phase II drug trials are conducted on animals, while Phase III drug trials are conducted on healthy volunteers. Both are required for FDA approval. True FalseIn terms of specificity and sensitivity, explain why drug population screening is not effectiveWhy is confirmatory test important to perform in different drug of abuse. Explain the toxic effect of the following: Cannabinoids Cocaine Opiates