Abstract

http://ssrn.com/abstract=2173774
 
 

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All that is Gold Does Not Glitter in Human Clinical Research: A Law-Policy Proposal to Brighten the Global 'Gold Standard' for Drug Research and Development


Michael J. Malinowski


Louisiana State University, Baton Rouge - Paul M. Hebert Law Center

Grant G. Gautreaux


affiliation not provided to SSRN

November 10, 2012

Cornell International Law Journal, Vol. 45, No. 185, 2012

Abstract:     
This Article challenges the global science standard for putting new drugs on pharmacy shelves. The primary premise is that the “gold standard” of group experimental design is an antiquated extension of drug development's crude-science past, and is inconsistent with the precision of contemporary genetics - the science that increasingly dominates the drug development pipeline. The Article identifies law-policy options that would raise the standard for human clinical research under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Number of Pages in PDF File: 20

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Date posted: November 12, 2012  

Suggested Citation

Malinowski, Michael J. and Gautreaux, Grant G., All that is Gold Does Not Glitter in Human Clinical Research: A Law-Policy Proposal to Brighten the Global 'Gold Standard' for Drug Research and Development (November 10, 2012). Cornell International Law Journal, Vol. 45, No. 185, 2012. Available at SSRN: http://ssrn.com/abstract=2173774

Contact Information

Michael J. Malinowski (Contact Author)
Louisiana State University, Baton Rouge - Paul M. Hebert Law Center ( email )
440 Law Center Building
Baton Rouge, LA 70803
United States
225-578-8716 (Phone)
Grant G. Gautreaux
affiliation not provided to SSRN
Feedback to SSRN


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