BLG 699 Chapter Notes - Chapter 2: Harvey Washington Wiley, United States Customs Service, Declaration Of Helsinki

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Good clinical practices (gcps) are the accepted procedures for conducting clinical trials: the basis is clinical trials because you"re testing on human subjects but it"s in a controlled environment. Gcp is defined as: an international ethical and scientific quality standard for: designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the. Declaration of helsinki, and that the clinical trial data are credible* Regulations milestones in the history of drug development. Congress enacted a law requiring the united states customs service. To stop the importing of adulterated drugs (they"re sort of getting legalized now but not yet) from outside the country. It took another 50+ years for the next major piece of legislation to come about.

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