Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 38

The drug development process depicted in Plate 1 is a lengthy and demanding endeavor. Good clinical practice is not an element in all of the steps, phases, and activities that makeup the full development process. However, keeping in perspective the fact that there are applicable regulatory requirements across the spectrum of the entire process and, at minimum best practices should be applied even when the step may not seem to involve regulatory oversight is a wise mindset to adopt. Applying the quality systems approach that is outlined in Chapter 30 as a guiding principle from the time a new drug concept is born to approval of a marketing application is a winning strategy.