The development of a new drug is a protracted, uncertain and unpredictable process which requires an integrated team effort, specialised technical expertise and the allocation of very significant financial resources. This article describes the steps involved in the production of a drug from the discovery stage to marketing. The strategic options available to chemists and the testing cascades required to identify compounds of interest are described. Before clinical trials can begin, extensive pharmacological, pharmaceutical and toxicological studies are required. Clinical studies begin in healthy volunteers and progress to more extensive trials in patients. At all stages, the development process is controlled by procedures established within the pharmaceutical company to ensure compliance with the requirements of regulatory authorities.
The chances that a new compound will prove to be of clinical value are rated no greater than 5000:1 and the cost of development of a drug is estimated to be in the range of ยฃ100-150 million. In such an environment, patent protection is needed to allow companies to recoup research costs but the extended development time now required to obtain a marketing authorisation is leading to significant erosion of effective patent life.
The topic is discussed in general terms with some greater emphasis on drugs used in anaesthesia. A brief history of the development of propofol is included to provide examples of some of the problems that may need to be overcome in developing a new drug.