Notes
Medicines for rare disorders are commonly called ‘orphan drugs’; further information can be found at http://www.fda.gov/orphan/index.htm.
Further information on paediatric medicines can be found on the CDER website at http://www.fda.gov/cder/pediatric/index.htm.
The use of trade names is for product identification purposes only and does not imply endorsement.
A ‘bridging’ study is defined as a study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety and dose regimen in the new region that will allow extrapolation of the foreign data to the population in the new region.
Information from Dr Terry Winters, Chairman and CEO, Vital Therapies, Inc., San Diego, CA, USA (www.vitaltherapies.com).
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Acknowledgements
Dr Kitler is a consultant at Associates for Business and Research (ABR), which specialises in all issues relating to the pharmaceutical and biotechnology industry. She can be contacted at fredfifijdk@yahoo.com; phone +41 21 824 1419.
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Kitler, M.E. 19th Annual Drug Information Association (DIA) EuroMeeting. Int J Pharm Med 21, 287–294 (2007). https://doi.org/10.2165/00124363-200721040-00005
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DOI: https://doi.org/10.2165/00124363-200721040-00005