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Describe the different types of trials a new drug must undergo before it is “ready for market.”
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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?What are the three main targets of drug design and development?Describe the significance of the use of pharmacokinetic parameters in case to calculate appropriate drug dosing regimens.
- How does physicochemical properties of a drug define its biological mechanism? Please explain at your own words.What are the potential implications of genetic variations in drug-metabolizing enzymes on individual response and therapeutic outcomes in clinical pharmacology?Using the diagram as a guide, briefl y explain how the three factors in drug therapy interact.
- Describe the factors that affect both drug absorption and bioavailability.How does genetics affect physiological drug response and metabolism? Name and describe an example of a specific genetic trait that alters drug response or metabolism.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 it
- 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 do you know about pharmacodynamic and pharmacokinetic drug development? Explain brieflyExplain the uses of the minimum inhibitory concentration and thetherapeutic index in drug selection.