Which of the following statements are true about the Hatch-Waxman Act? Select one or more: O a. The Act benefits the manufacturer of reference drugs by extending the patent. O b. The Act benefits the manufacturer of reference drugs by eliminating reporting requirements for changes in the manufacturing process. O c. The Act benefits the manufacturer of generics drugs by eliminating reporting requirements for changes in the manufacturing process. O d. The Act benefits the manufacturer of generics drugs by eliminating the need for clinical trials.

Answer the following question using the provided textbook link: https://pressbooks.calstate.edu/explorationsbioanth2/chapter/11/ A) In one paragraph, in your own opinion, explain what is the connection between disease and lack of exercise according to the textbook? B) In one paragraph, in your own opinion, describe the kinds of diseases early humans had to contend with and how early people got them according to the textbook. C) In one paragraph, in your own opinion, explain how does the health of preagricultural humans compare to the health of modern humans according to the textbook?

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.

Which of the following situations related to oral chemotherapy treatment is most likely to result in serious adverse effects? A. A patient obtains a refill of the prescription and continues to take the medication during the "off week". B. A family member brings the medication bottle and dosing schedule to the follow-up appointment. C. A patient misses a follow-up appointment because he is unable to pay for transportation to the clinic. D. The new cycle of treatment is delayed because the edication is unavailable from the pharmacy.

Your company has been hired by a medical device company that is in the business of commercializing materials. Use the knowledge you have learned in class to design a hip implant/prostheses. Draw and describe your design focusing on material selection and fabrication of the device. Please select the appropriate materials for specific parts of your device and justify your designs. You need to also consider the degradation materials in the body. How would you characterize the materials used in your device? Please explain the appropriate methods and instruments for the device characterization.

The half-life of a drug has been determined to be 6 hours. The initial drug concentration was measured at 36mg%. What will the drug concentration be after 3 half-lifes? 10. A. 18mg% B. 9mg% C. 3mg% D. 4.5mg%

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?

Who determines whether your application for a Therapeutic Use Exemption (TUE), allowing you to use a prohibited substance for medical necessity, is approved or denied?   Question 15Answer a.   A group of professionals working for the national/international sports federations.   b.   The president of the national or international sports federations   c. The doping control officer and his team d.   A committee of medical experts

Read chapter 35 of your textbook and review the information about dosage calculation. Analyze the following hypothetical situation:Sam is a CMA (AAMA) certified medical assistant working at a family medicine practice. He is working in the clinical area and receives an order form the doctor. The medication order reads: dexamethasone 6 mg IM qid to administer to a 25-year-old female. That same day, the pharmacy supplies Decadron ampules of 4 mg per mL. According to what you have studied this week, what do the abbreviations IM and qid mean? Can Sam administer Decadron even though the order reads dexamethasone? Why or why not? How many mL of the medication should Sam administer? Explain how you obtained the answer. What site of administration would you pick for this patient?

You isolate a new natural product from a sponge. Because it is new and non-obvious, you suggest to your PI that it should be patented. After filing an invention disclosure with the OIC, you are told it is not eligible for patenting without evidence that the compound is