J. Hackett

Regulatory Issues in the Co-Development of Oncology Drugs and Proteomic Tests: An Overview

G. Pennello, M. Chan, D. Li, 2008 .

Medical applications of microarray technologies: a regulatory science perspective

Emanuel F. Petricoin, Janet Woodcock, Kathryn C. Zoon, 2002, Nature Genetics.

11 Regulatory Aspects of the Oncology Drug Diagnostics Co-Development Process by Proteomics Approach

G. Pennello, M. Chan, D. Li, 2007 .

Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA‐PWG‐PhRMA‐DruSafe Workshop

Shiew-Mei Huang, L. Lesko, A. Dorner, 2003, Journal of clinical pharmacology.

Quality control of microarray assays for toxicogenomic and in vitro diagnostic applications.

Joseph Hackett, Karol L Thompson, K. Thompson, 2008, Methods in molecular biology.

Microarray data—the US FDA, industry and academia

L. Lesko, J. Hackett, Lawrence J. Lesko, 2003, Nature Biotechnology.

Molecular diagnostics: an FDA perspective

A. Ardekani, Emanuel F. Petricoin III, J. Hackett, 2003, Expert review of molecular diagnostics.

The drug diagnostic co-development concept paper Commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop

L M Hinman, S-M Huang, J Hackett, 2006, The Pharmacogenomics Journal.

Introduction to the Food and Drug Administration (FDA) regulatory process.

J. Hackett, S. Gutman, Steven I Gutman, 2005, Journal of proteome research.