Pharmaceutical Statistics Using SAS

1.6. Emerging opportunities

The Critical Path initiative document describes many opportunities to improve the efficiency of product development. We will mention just a few here. On better tools to assess a compound's safety, FDA states the need for new techniques to evaluate drug livertoxicity, new methods to identify gene therapy risk, better predictors of human immune responses to foreign antigens, new methods to further enhance the safety of transplanted human tissues, and efficient protocols for qualifying biomaterials. On better tools to demonstrate the medical utility of a compound, FDA shares the agency's successfully experience with biomarkers in HIV infection and duodenal ulcer healing. FDA states the need for more biomarkers and surrogate ...