Translation of CUD Therapeutics from Drug Discovery to the Clinic
The first part of this chapter will outline the typical designs used in modern drug discovery programs, starting with initial hit discovery and leading up to the point that FDA permits “first-in-human” testing. It is intended that this outline will provide insight into the different skill sets and ways of thinking and working that are needed to bring a new medication to the clinic. The purpose is not only to provide basic scientists with a view from the “other side” but also to convey the complexities involved in drug development projects, as a way of explaining why it takes so long to get from initial discovery to clinical testing. Having covered some of the considerations of the drug development process, the second half of the chapter will discuss experimental approaches used to date to treat cannabis use disorder (CUD) as well as a brief history of cannabinoid pharmacology (and physiology). It is hoped that these factors may clarify where we have come from, why it has taken so long, and the direction forward.
KeywordsCannabis use disorder CUD Drug Master File Fatty acid amide hydrolase Good clinical practice (GCP) Good laboratory practice (GLP) Good manufacturing practice (GMP) Investigational new drug Monoacylglycerol lipase Negative allosteric modulator Biased agonist Drugability
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