The Development of Clinical Guidelines

  • M. N. G. Dukes
Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)


One cannot really give an account of the development of “clinical guidelines” by drug regulatory agencies and others in recent years without first defining what one means by a guideline, since the term is used in several different senses. What these documents have in common is - or should be - that they serve only to guide, and that regulators, applicants and investigators must feel free to deviate from them where there is sufficient reason to do so.


Sufficient Reason European Economic Community CLiNICAL Requirement Drug Regulatory Agency Individual Recommendation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer Science+Business Media New York 1981

Authors and Affiliations

  • M. N. G. Dukes
    • 1
  1. 1.Department of Pharmacotherapy Central Inspectorate for DrugsNetherlands Ministry of HealthThe Netherlands

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