Good Clinical Practice (GCP)

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Abstract

In accordance with guidelines published by the Food and Drug Administration, International Conference on Harmonisation of Technical requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practices (GCPs), GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting the results of clinical trials that involve participation of human subjects. The objective of this ICH GCP guidelines is to provide a unified standard for European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by regulatory authorities in these countries.

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Sawant, S. P., Parihar, H. S., Mehendale, H. M., & Hanson, K. M. (2014). Good Clinical Practice (GCP). In Encyclopedia of Toxicology: Third Edition (pp. 772–777). Elsevier. https://doi.org/10.1016/B978-0-12-386454-3.00318-3

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