Drug development procedures

In the fundamental change scenario current drug development procedures are fundamentally reconfigured and pharmacogenetic testing is used to restrict the group of... 

SAS has always had and will maintain a central role in the data management, analysis, and reporting of clinical trial data. Because of the strong suite of SAS statistical procedures and the power of Base SAS programming, SAS remains a favorite of statisticians for the analysis of clinical trial data. Several companies have built their clinical trial data management and statistical analysis systems entirely with SAS software. More recently, SAS has offered SAS Drug Development as an industry solution that provides a comprehensive clinical trial analysis and reporting environment compliant with 21 CRF-Part 11. 

Drug development is ideally a logical, step-wise procedure in which information from small early studies is used to support and plan later larger, more definitive studies. To develop new drugs efficiently, it is essential to identify characteristics of the investigational drugs in the early stages of development and to plan an appropriate development based on this profile. 

In this chapter we report recent advantages in analytical method hyphenation and chemometric approach applied to drug development, especially related to last trends in pharmaceutical field and to advantages in terms of high-throughputs procedure and instrumentations. 

All these problems were successfully solved after the validation of the novel procedure (instrumentation) and then can be easily applied in the pharmaceutical industry for screening of enormous numbers of compounds in the drug development process. Several compounds are tested against different biological targets usually in 96- and 384-well plates, but to improve the HTS, 1536- or 3456-well plates are also used. 

In the development of new biopharmaceutical molecules, there is a constant need for analytical methods that provide critical information in areas that range from early characterization to routine analysis of approved products. Past experience indicates there are few projects in drug development that can be addressed by standard analytical procedures. Even well-established techniques often have to be modified to better suit the analysis of new samples. For this reason, a broad range of techniques is already an integral part of laboratories in the biopharmaceutical industry. 

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