Process evaluation nomenclature

The nomenclature for early clinical studies is not fully standardized. In addition to first-in-human evaluations, Phase I trials are appropriate throughout the drug development process as specific issues arise that require clinical pharmacologic investigation. Further, some exploratory hrst-in-human studies are currently being described as "Phase Zero," in which the goals are somewhat different from classic Phase I trials. 

Chapters 2, 3, and 4 deal with the distillation variables, and Chapter 5 covers distillation process control strategies. Chapter 6 describes some of the constraints on distillation variables and separation capabilities. Chapter 7 introduces the concepts that are critical to product quality and the measurements that evaluate performance criteria such as frequency of failure. Chapter 8 describes the concepts and nomenclature that are fundamental to PID control loops. Chapter 9 covers the concepts of tuning process controllers when they are operating in automatic output mode. Chapter 10 is about measuring the response of process variables when the controller is in manual output mode, that is, with no feedback from the process variable. 

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