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Drug Regulatory Affairs
NTIS | 1988|regulations issued by the U.S. Food and Drug Administration. In order to accomplish the execution of this drug development program, the Pharmaceutical ...Keywords: Drug compounding -
Clinical research practices and drug regulatory affairs : a journal devoted to documentation of the clinical research process in the pharmaceutical industry
Catalogue medicine | 1.1983 - 8.1990/91 -
Careers in Regulatory Affairs
Wiley | 2010|such as pharmaceutical regulatory affairs (RA). RA operates at the interface of science, law, and business, applying scientific rationale along ...Publisher: Federation of American Societies for Experimental Biology -
Review of: Fundamentals of US Regulatory Affairs, 7th ed.
Online Contents | 2011|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Comparison of the Drug Review Process at Five International Regulatory Agencies
Online Contents | 2007|Abstract Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Review of Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional
Online Contents | 2012|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists
Online Contents | 1998|information to the overall drug development campaign. The purpose of the tutorial described here was to allow regulatory affairs specialists to gain a ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Guest Editor’s Note: Regulatory Affairs
Online Contents | 2002|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Interim Analysis: What Regulatory Affairs Professionals Need to Know
Online Contents | 2010|under an Investigational New Drug Application. Herein, I review the types of trials that may benefit from DMC involvement and provide an example ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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