Use of Imaging Biomarkers for Regulatory Studies

by Peter Steiger

J Bone Joint Surg AmVolume 91(Supplement 1):132-136

February 1, 2009

©2009 by The Journal of Bone and Joint Surgery, Inc.

The regulatory approval process for medical devices and drugs requires initial clearing of the product by an Investigational New Drug (IND) or Investigational Device Exemption (IDE), followed

by one or more clinical trials that are conducted following numer...

Peter Steiger J Bone Joint Surg Am 2009;91:132-136

©2009 by The Journal of Bone and Joint Surgery, Inc.

The four phases and building blocks of a clinical trial involving imaging biomarkers.

Peter Steiger J Bone Joint Surg Am 2009;91:132-136

©2009 by The Journal of Bone and Joint Surgery, Inc.

Ongoing processing of imaging biomarkers in a regulatory trial.

Peter Steiger J Bone Joint Surg Am 2009;91:132-136

©2009 by The Journal of Bone and Joint Surgery, Inc.