Volume 37, Issue 1 supplement

November 2014

Liver Safety Assessment in Clinical Drug Development: A Best Practices Workshop report

Issue Editors:

6 articles in this issue

The Clinical Liver Safety Assessment Best Practices Workshop: Rationale, Goals, Accomplishments and the Future
Paul B. Watkins
Michael Merz
John R. Senior
Foreword Open access 29 October 2014 Pages: 1 - 7
Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges
John R. Senior
Review Article Open access 29 October 2014 Pages: 9 - 17
Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials
Mark I. Avigan
Einar S. Bjornsson
Michael Merz
Review Article Open access 29 October 2014 Pages: 19 - 31
Methodology to Assess Clinical Liver Safety Data
Michael Merz
Kwan R. Lee
Paul B. Watkins
Review Article Open access 29 October 2014 Pages: 33 - 45
Causality Assessment for Suspected DILI During Clinical Phases of Drug Development
Arie Regev
Leonard B. Seeff
Paul B. Watkins
Review Article Open access 29 October 2014 Pages: 47 - 56
Liver Safety Assessment in Special Populations (Hepatitis B, C, and Oncology Trials)
Gerd A. Kullak-Ublick
Michael Merz
Paul B. Watkins
Review Article Open access 29 October 2014 Pages: 57 - 62

Search