The role of reference intervals of laboratory tests in early phase clinical research in healthy volunteers

• Main Authors: A. V. Vozzhaev (Author), S. B. Fitilev (Author), I. I. Shkrebniova (Author), D. A. Kliuev (Author), A. A. Vdovina (Author), L. A. Miasnikova (Author)
• Format: Book
• Published: Izdatelstvo OKI, 2018-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

This article discusses one of the most disputable issues in national clinical research practice in healthy volunteers. Regulatory requirements forbid to assess even minor deviations of laboratory parameters from reference intervals as not clinically significant. Authors made analysis of such require...