Introduction The drug development process is a clinical process that has its own language. It is not required that SAS programmers function as a MD or a regulatory expert, but working knowledge of the terminology is important to be effective. This section will walk through the drug development process from discovery to Phase IV. It will explain a wide range of acronyms such as IND, NDA , GCP and MedDRA . It will also describe some of the terminologies used within the process of clinical trials as a drug is developed and submitted to the FDA . This will give SAS programmers a larger perspective and context to their work during the analysis and reporting of clinical trials data. This section will tell a fictitious story about a college graduate named James who is starting a new position at a pharmaceutical company. Each new term James encounters is presented in bold and italicized for emphasis. As he enters a new professional world, he meets many people and learns new processes that...
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