Anthony W Fox

President, EBD Group, Carlsbad, California.

Having covered in Sections II and III the strictly clinical, more orthodox aspects of drug development, we now turn to some applied aspects. In general, these reflect relatively modern sophistications in the development process, compared with, for example, many types of clinical trial design, which have been available for decades.

These modern aspects of drug development are rarely optional. All are crucial for the success of a product in the marketplace. Several of the next chapters describe methodologies that teach us, on new dimensions, about properties that are intrinsic to drugs. Some (e.g., pharmaceoeconomics) are also becoming of increasing importance in the regulatory approval process.

0 0

Post a comment