Some Best Practices for Supplying Clinical Drug Products Internationally
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Drug lnformarion Joicnial, Vol. 35. pp. 485-491, 2001 Printed in the USA. All rights reserved.
SOME BEST PRACTICES FOR SUPPLYING CLINICAL DRUG PRODUCTS INTERNATIONALLY CHARLES F. CARNEY Associate Director. Investigational Supplies. Pharrnaceutics Department, Boehringer lngelheim Pharmaceuticals, Inc.. Ridgefield, Connecticut
Contemporary drug development requires conducting clinical trials on an international basis. Meeting the needs for supplying the drug product to these trials must be performed in the most time effective manner. Appropriately manufactured. packaged. and labeled trial supplies must be delivered to many sites in mnny countries which have diverse regulatory requirements. Some ideas for optimizing the procedures for getting the appropriate information. planning, and executing the proper logistics, accommodating varying national cultures. arid meeting the technical nnd compliance needs for the product will be presented. Key Words: Clinical supplies; Information strategy: Logistics; National cultures: Development continuum
INTRODUCTION IN ORDER TO REMAIN competitive, pharmaceutical companies must market in as many regions of the world as possible. These same companies must look to all of the regions for adequate numbers of investigators, sites, and subjects to satisfy the increasing requirements for performing clinical trials. In order to satisfy the various demands for studying genetic effects on drug product safety and efficacy these companies must find the appropriate genetic subjects, who are usually located in specific regions of the world. These factors establish the requirement that a company must develop and utilize a global concept for all clinical trials
Presented at the DIA 36th Annual Meeting, June 1115, 2000, San Diego, California. Reprint address: Charles F. Carney, Associate Director, Investigational Supplies, Phannaceutics Department, Boehringer Ingelheiin Phmaceuricals, Inc., P.O. Box 368, 900 Ridgebury Road. Ridgefield CT 06877.
today. This paper will summarize some of the concerns and point out some best practices for supplying clinical drug products, properly produced, packaged, labeled, controlled, and distributed in this continually changing global environment.
INFORMATION AS A STRATEGIC TOOL Many people say that now is the “age of information” and that is certainly true in the pharmaceutical industry. The scientific information required to develop a pharmacologically relevant new chemical entity must include not only chemical synthesis and structure/activity assurance but also must take into account all regulatory concerns of the many regions of the world. Determining how to study and analyze the toxicology profile, how to set specifications for impurities in the drug substance and degradation products in the drug product (measured in the .01 to . l % range), and how to prove (validate)
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the production processes to the satisfaction of the many diverse regulato
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