Marketing phase

Potential new drugs that show acceptable toxicity in animals are usually first tested in healthy human volunteers before being investigated in patients. Chapters 3-6 deal with these aspects of new drug development, and it is the purpose of this chapter to consider how safety should be evaluated at the time of the product licence application and in the post-marketing phase. 

In the pre-marketing phase of new drug development national regulatory authorities encourage and evaluate a broad range of experimental methods that come within the definition of clinical trials. 

Indeed, the relative simplicity of the system as it stands, and the flexibility it gives to Member States, should to some degree be considered as an opportunity for experimentation. For example, benchmarked allocations in a range of sectors may be an attractive approach for the longer term but this is far from certain, given the complexities. If phase I was mainly about establishing the market, phase II offers the chance for national experimentation with some of these allocation possibilities. 

Phase 4 spans the entire period of time after the drug has been approved and entered the market. Phase 4 studies are implemented when the FDA requests a drug company to examine newly discovered drug hazards. In my interviews with FDA officials, they agreed that this crucial... 

This can also be called the pre-marketing phase of the drug life cycle. It should be noted that although all this is necessary, it is certainly not sufficient for commercial success. 

In addition to these advances, a number of device developments have focused on using the established capsule technologies. These new designs on an old theme appear to be have been successful [13], although a number have still to make it through the approval process to the marketing phase. 

Phase III and phase IV clinical trials involve larger populations. During phase III trials, which can last two to eight years, a drug is often brought to market. Phase IV studies continue after the drug is being marketed. 

Nevertheless, there are no current examples of fluorinated anthracydines being included in cHnical trials or better, in clinical practice, and the few compounds reaching advanced development all failed to enter the marketing phase [6]. As a consequence, there is reduced interest in recent years by the scientific commimity in this class of fluorinated compounds. A few years ago, one of the authors published an overall review on this subject [7j. Sub-... 

---