Define the following terms: • Preclinical Trial • Clinical Trials • FDA Review • Lead discovery • Molecular target-based screening • Phenotypic screening
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Q: Describe the attributes of the three phases of FDA Drug Review for Human Testing
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Q: Describe two approaches to early drug discovery.
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Q: Identify potential barriers to inspection readiness in relation to site inspections in clinical…
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Q: Summarize the purpose of phases I through III of a clinical trial.
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Q: 1. What are the commonly used animals employed in nonclinical studies? Discuss its pros and cons.
A: Non -clinical studies are done In vitro or i vivo experiments in which test articles are studied…
Q: precision medicine vs standard therapy compare the two in details.
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Define the following terms:
• Preclinical Trial
• Clinical Trials
• FDA Review
• Lead discovery
• Molecular target-based screening
•
Step by step
Solved in 2 steps
- 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?Identify potential barriers to inspection readiness in relation to site inspections in clinical trials.Why is a therapeutic, cost-effective, and informative formulary system valuable or beneficial to a hospital and its patients? Please explain further your opinions or insights. • If you were to critique the stages of clinical trials, what would you modify and advocate for the system's improvement? Please explain further your opinions or insights.
- In terms of specificity and sensitivity, explain why drug population screening is not effectiveDiscuss controlled release technology and its significance for the maintenance of constant drug levels in light of the evolution of sensor manufacturing technology and its contribution to the 4th Generation of Smart DDS.What are some challenges that you foresee when implementing Precision Medicine (which includes Pharmacogenomics and Immunogenomics as well as Risk Screenings for certain cancers)? This can include ethical, financial, social, legal, etc. challenges. Please provide some examples when discussing your identified challenges. How might you tackle these challenges you comment on above? How might your solutions influence/impact the patient when utilizing Precision Medicine?
- • In your own words...how the heck do primers work? What are they actually doing that enable us to use them as a tool in diagnostic science?10) List down 3 different test animals and give samples for which purposes they can be used in testing of a designed biomaterials? 11) What does FDA abbreviation stand for? 12) Order for the below given steps prior to FDA approval ? Controlled clinical trials In vitro testing (“in glass") In vivo testing w/animal models of disease In vivo testing w/healthy animalsprecision medicine vs standard therapy compare the two in details.