eam Work and Critical Thinking Rubenfeld & Scheffer (2015) suggested

Answer the following questions to develop a viable clinical trial strategy: Your goal is to identify a NCE or NME based on the target and/or indication of the drug you presented in M03: P01-Presentation. To facilitate this, you decide to purchase a commercially available chemical library from Enamine and screen the library in your assay (see https://enamine.net/compound-librariesLinks to an external site.). Looking through the available libraries on the Enamine website, which library would you select for your task, and why? Important notes about compound library selection You eventually optimized one of your selected compounds and are starting to think about clinical development. Briefly explain the importance of understanding any off-target pharmacology with your drug. Briefly describe the importance of having a therapeutic index > 10. Briefly define ‘IND’. At what stage of the drug development process would you submit an IND application to the FDA? Briefly explain the importance of the FDA approval process. Briefly explain the importance of GLP and GMP with regards to developing a small molecule drug. Briefly explain the differences among Phase 1, Phase 2 and Phase 3 clinical studies. Briefly explain a situation where you would use the Animal Rule. Based on your responses to these questions, devise a mock IND for a Phase 1 trial using your proposed drug candidate The target or drug presented in M03:P01-presentation is Rinvoq(Upadacitinib) which is a JAK inhibitor. Can you please explain exactly what I should be doing because I am very confused. Thank you in advance!

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