Scientific Publications on the Critical Path Initiative

The FDA's Critical Path Initiative: A Brief Introduction

Stephen Joel Coons, PhD, Director Patient-Reported Outcomes Consortium, Critical Path Institute

Clinical Therapeutics/ Volume 31, Number 11, 2009

CAMD: Developing Tools for an Integrated Drug Development Process for Alzheimer's and Parkinson's Diseases

K Romero, M de Mars, D Frank, M Anthony, J Neville, L Kirby, K Smith and RL Woosley

Clinicalpharmacology & Therapeutics 86-4 2009 October

Translational Toxicology and the work of the Predictive Safety Testing Consortium

Mattes WB, Walker EG. Clin Pharmacol Ther 2009; 85(3):327-30

The FDA critical path initiative and its influence on new drug development *

Woodcock J, Woosley R.
2. Annu Rev Med 2008;59:1-12

Strategic paths for biomarker qualification.

Goodsaid FM, Frueh FW, Mattes W.
Toxicology 2008 March 20;245(3):219-23

PharmacoVigilence - The FDA's Critical Path Initiative.

PharmacoVigilence Review • Volume 1 Number 3, August 2007

The Predictive Safety Testing Consortium:  A synthesis of the goals, challenges and accomplishments of the Critical Path.

Goodsaid F, Frueh F, Mattes W.
Drug Discovery Today: Technologies 4[2], 47-50. 2007

Drug development and the FDA's Critical Path Initiative.

Woosley RL, Cossman J.
Clin Pharmacol Ther 2007 January;81(1):129-33