New chemical entities (NCEs) are discovered through screening existing compounds or designing new molecules. Once synthesized, they go through a...
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 paper 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.
Clinical Trial Acronyms – Source: CDISC
Clinical Trials Glossary– Source: CDISC