Module 2 DB

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Dec 6, 2023

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Hello everyone, this is my discussion post for Module 2. Answer 1: Typically, researchers are in charge of discovery and preclinical development, not the FDA. During the discovery stage, researchers test many compounds to figure out which is the best at combatting a disease. According to the U.S. Food & Drug Administration, researchers conduct “many tests of molecular compounds to find beneficial effects against any of a large number of diseases” (US FDA, 2018). Researchers are also in charge of preclinical development. This stage is important, because it evaluates a drug’s toxicity. Under the FDA’s requirement, researchers must “use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory studies” (US FDA, 2018). This ensures the quality and safety of the preclinical studies. Overall, researchers are responsible for discovery and preclinical development. References Commissioner, O. of the. (2018a, January 4). Step 1: Discovery and Development . U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-developme nt Commissioner, O. of the. (2018b, January 4). Step 2: Preclinical research . U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research Answer #2: The purpose of Drug Trials Snapshots is to inform companies about the demographic of the participants in the clinical trials. This is helpful to them, because they can see if their drugs affect demographic groups differently. According to the U.S. Food & Drug Administration, the

Drug Trials Snapshots “also highlights where the trials were conducted and whether there were any differences in the benefits and side effects among different demographic groups (sex, race, age, and ethnicity)” (U.S. FDA, 2023). Through Drug Trials Snapshots, companies are able to monitor the progress of clinical trials and take into account different side effects among demographic groups. References Center for Drug Evaluation and Research. (n.d.). Drug trials snapshots . U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Answer #3: I chose to look at Ajovy, because I used to see this drug a lot when I worked as a pharmacy technician. I always wondered what this was for, since it seemed to be a pretty common drug. Throughout my time as a pharmacy technician, I became familiar with many drugs and their purposes, but I have never really researched Ajovy before for some reason. When I saw Ajovy pop up on the Drug Trials Snapshots, I just knew I had to find out more information. References Center for Drug Evaluation and Research. (n.d.). Drug trials snapshots . U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Answer #4: Ajovy is used to prevent migraines in adults. Based on the Drug Trials Snapshots from the U.S. FDA, “Ajovy is a calcitonin gene-related peptide antagonist indicated for the preventative treatment of migraine in adults” (US FDA, 2018). Calcitonin gene-related peptide

(CGRP) antagonists are a type of migraine medication that doesn’t have vasoconstrictive action (narrowing of blood vessels). According to the National Center of Biotechnology Information, CGRPs have “fewer adverse effects and [have] a possible longer period of activity than triptans” (National Center of Biotechnology Information, 2023), which are another type of migraine medicine. Under the patient’s perspective, CGRPs such as Ajovy are a great option for treating migraines, compared to triptans. Triptans are known for having numerous side effects, such as “dizziness, dry mouth, muscle weakness, and nausea” (WebMD, 2023). Since Ajovy has fewer side effects and may affect patients for a longer time, it will be more effective at treating migraines. The patients will feel more energized and be more willing to take their medications, due to less side effects. To sum it up, Ajovy is a great and effective option to treat migraines, one of the most common health conditions. References A;, R. A. (2023, July 10). Calcitonin gene-related peptide receptor . National Center for Biotechnology Information. https://pubmed.ncbi.nlm.nih.gov/32809483/ Booth, S. (2023, February 13). Triptans (serotonin receptor agonists) for migraine headaches . WebMD. https://www.webmd.com/migraines-headaches/triptans-migraines Center for Drug Evaluation and Research. (n.d.). Drug trials snapshots . U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots U.S. National Library of Medicine. (2023, February 2). Vasoconstriction: Medlineplus medical encyclopedia . MedlinePlus.

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https://medlineplus.gov/ency/article/002338.htm#:~:text=Vasoconstriction%20is%20the %20narrowing%20(constriction,%2C%20medicines%2C%20or%20psychological%20co nditions. Sincerely, Audrey Nguyen

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