ABSTRACT
As discussed in Chapter 1, the marketing of pharmaceuticals relies on the approval of government regulatory agencies such as the FDA. Given the legal and ethical responsibilities of such organizations, they demand that the data submitted by sponsors in support of licensing applications are of the highest standard. To give an idea of this, the acceptable error rate for a Phase III database is <0.1% for safety and efficacy parameters (critical) and <0.5% for non-critical fields (PharmaNet). Indeed the ICH GCP Guidelines amount to a total quality management plan for drug development, defining an auditable process for handling both the risk of exposing humans to unproved NASs, and demonstrating the reliability of the data collected.
