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The Stages behind Developing a New Drug in Industry … Part 4

Drug Trials commence with in vitro and in vivo experiments on nonhuman subjects and observing the effects of the candidate drug(s). These are commonly referred to as the pre-clinical trials. Once safe and effective thresholds have been set, the candidate drug(s) can be administered to human subjects and thus begin the clinical trials. The clinical trials are divided into various Phases I, II, III, IV.

In a concerted effort, preformulation studies look at the candidate’s solubility, stability, crystal properties, etc. to optimize the method of delivery. As testing nears completion (or soon after the Drug Design stage is complete), an application for a new drug is submitted to an internal regulatory board and a patent is filed.