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Original Question
Name: ___________________________ Module 13: Assignment Module 13 was a great review for the course PHDD8010. For the last assignment before the final exam please answer the following question. From the below figure (Highlights of Prescribing Information-Table of Contents) list ONE (and only ONE) reason why it is important in Drug Development. If you add more than one reason, I will not grade that section and you will receive a 0 for that section. Each “section” (Indications and Usage, Dosage and Administration… etc) will be worth 5 points. You must add one reference as indicated in the example below. If you fail to provide a reference for any of the below sections, you will receive a 0 for the whole assignment. Please follow the format given to you below. No late assignments will be accepted. If there are sections that have following bullets, you still will only list one reason why it is important in drug development. For example, Section 9 (Drug Abuse and Dependence) lists three drop down bullets. You will only need to list one reason as a WHOLE for Drug Abuse and Dependence. I do not want a reason for 9.1, 9.2, and 9.3. I only want ONE reason for section 9. For example: 1. Indications and Usage a. Important Because: Indications and Usage are important in drug development because how the product is used is regulated by its own FDA guidelines such as 501K and PMAs, and the drug itself has its own regulations such as INDs and NDAs. i. Reference: Week 12 Lecture (Stephanie Johns) Figure 1: Full prescribing information Table of Contents 1. Indications and Usage a. Important Because: i. Reference: 2. Dosage and Administration a. Important Because: i. Reference: 3. Contraindications a. Important Because: i. Reference:
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