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ToxSci Advance Access originally published online on May 12, 2009
Toxicological Sciences 2009 110(1):40-46; doi:10.1093/toxsci/kfp088
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© The Author 2009. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Toxicity Testing in the 21st Century: A View from the Pharmaceutical Industry

James S. MacDonald*,1 and Richard T. Robertson{dagger}

* Chrysalis Pharma Consulting, Chester, New Jersey 07930 {dagger} Bristol Myers Squibb Company, Research and Development, Princeton, New Jersey 08540

1 To whom correspondence should be addressed at Chrysalis Pharma Consulting, 385 Route 24, Suite 1G, Chester, NJ 07930. E-mail: jmacdonald@chrysalispharma.com.

Received April 6, 2009; accepted April 25, 2009

The first 150 words of the full text of this article appear below.


   INTRODUCTION
 
The report by the U.S. National Research Council entitled Toxicity Testing in the 21st Century: A Vision and a Strategy (National Research Council, 2007Go) lays out a bold vision for the future of toxicity testing of chemicals based on the explosive changes that have been and are occurring in the basic biological sciences. Our understanding of basic cellular biology has grown remarkably in the last years to the point where many cellular processes are well characterized at the molecular level.

In contrast to this dramatic change, the approaches that have been taken to assess human risk of adverse effect from chemical exposure have changed little over the last several decades. This is reflected in the global regulatory requirements for registration of new agricultural, veterinary, and human pharmaceutical chemicals; the data requirements for these classes of chemicals have changed little since their establishment three and sometimes four decades ago despite . . . [Full Text of this Article]


   POINTS TO CONSIDER
 
Spectrum of Adverse Effects Can Result from Complex Events in Multiple Cellular/Organ Processes
Need for Effective Predictive In Vitro Systems
Biotransformation
Chemical Characterization Using In Silico Approaches

   WHERE WE ARE TODAY IN EMPLOYMENT OF ALTERNATIVE TECHNOLOGIES TO ASSESS POTENTIAL HUMAN RISK
 

   A PERSPECTIVE ON THE BEST WAY FORWARD
 

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Toxicity Testing in the 21st Century: A View from the Chemical Industry
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