Describe the FDA approval process for assessing the safety and efficacy of a newly developed drug. What are advantages and disadvantages of this process?
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Describe the FDA approval process for assessing the safety and efficacy of a newly developed drug. What are advantages and disadvantages of this process?
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- 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?Briefly describe the steps involved in the development and approval of a new drug in the United States: List two pros and two cons about this process and what are your personal thoughts about itThe acronym, USP, referenced on the Data Analysis page refers to the United States Pharmacopeia. Which of the following statements is not true about the USP? a) mission is to improve global health by issuing public standards and related programs to ensure the quality, safety, and benefits of medicines and foods b) generates chemical reference standards and official test methods for medicines and foods to ensure their quality and safety c) is responsible to provide the U.S. with a reliable, affordable, universal mail service d) is a non-profit scientific organization founded in 1820 in Washington D.C.
- What are the possible lab hazards that may occur during the processing and manufacturing of drugs in industry?The Food and Drug Administration (FDA) is responsible for: A. Requiring drug manufacturers to provide notice that a new drug is safe. B. Recalling pharmaceuticals only after harm has occurred. C. The approval before a new drug can be marketed. D. The assumption that the manufacturer of drugs would have conducted safety tests before marketing a new drug and protocols have been established.Which of the statements below is true about pharmaceutical or drug packaging? a.) FDA maintains tight control over regulations b.) cost is a major consideration when designing a package c.) advertising and communicating with the consumer is important for both prescription and OTC drugs. d.) shelf life is always shorter than for food so must choose material appropriately.
- A new drug has been approved for use, and the drug manufacturer has made it available for sale. During the first 6 months, the FDA receives reports of severe adverse effects that were not discovered during the testing and considers withdrawing the drug. This illustrates which phase of investigational drug studies? a )Phase I b) Phase II c )Phase III d )Phase IVWhat is high throughput screening in the discovery of drug ?The "gold standard" of drug efficacy studies is the double-blind, placebo-controlled design. Which of the following most likely prevents our ability to reach firm conclusions? A) We cannot conduct this type of research due to federal rules regarding research ethics. B) Participants can usually tell the difference between an active drug and a placebo. C) Observers typically know which participants are taking the placebo. D) Most of the drugs we wish to test are technically illegal.
- 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?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. Select all that apply. Group of answer choices Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective. Client variability is determined and potential drug—drug interactions are examined during pre-clinical testing.. The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans. 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.What is the meaning/definition of parent drug? And give its function and examples.