Good clinical practice drug development

Guarino, R.A. Practice and Application of Good Clinical Practices. Concepts and Strategies in New Drug Development Clinical Pharmacology and Therapeutic Series Praeger Publishers New York, 1983 4. 

Mathieu M (1997) Good clinical practices (GCP). In New Drug Development A Regulatory Overview, 5th edn., pp. 163-184. Waltham, MA PARAXEL International Corporation. 

The CBETS asks what tasks the sponsor needs to have done to meet its drug development goals and objectives. The primary tasks of clinical research and good clinical practice can be described rather precisely. Once one knows what the major tasks are and what activities are needed to accomplish these tasks, one can define the knowledge and skills needed by staff to complete the tasks and, finally, what education and training should be provided to imderstand the knowledge and skills. 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

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