E-DRUG: New Test Method for Oseltamivir
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GPHF-Minilab for the Detection of Counterfeit Medicines
New Test Method for Oseltamivir (Tamiflu*)
Dear Colleagues,
In the face of the dangerous trade in counterfeit medicines, the
quality of pharmaceuticals has increasingly become a global concern.
Weak drug quality assurance capacity in many countries exacerbates the
challenge of coping with diseases such as HIV/AIDS, TB and malaria.
For oseltamivir, the antiviral used to treat avian influenza,
regulatory experience is limited and well-established quality standards
are not yet widely available. A global pandemic might worsen the
situation even further by triggering "panic purchases" of substandard
medicines in particular from convenient but unreliable sources including
some internet sites. To ensure that only good quality medicines reach
priority public health programs, the USP Drug Quality and Information
(USP DQI) program supported by the U.S. Agency for International
Development (USAID) and the German Pharma Health Fund (GPHF) have
developed a simple and affordable screening method for oseltamivir
phosphate.
After a few months of development, we at USP DQI, USAID and GPHF are
pleased to provide this new thin layer chromatographic test method to
the public health community. The existing Minilab equipment and starter
kit chemicals already accommodate this new test method, and authentic
secondary reference standards can be obtained through GPHF's logistics
partner, Technologie Transfer Marburg (TTM).
We hope that you will assist us in promoting this important information
to the appropriate audiences in your organization and in your country.
We would especially appreciate your informing relevant national
societies, local hospitals and other health institutions or programs.
USP DQI, with support from USAID, is currently using the GPHF-Minilab
to provide technical assistance in postmarketing surveillance to
medicines regulatory agencies, national disease control programs, and
drug quality laboratories to reduce the prevalence of poor quality
medicines in developing countries.
For more general information, procurement details and technical
assistance related to this new method for oseltamivir, contact either
Natalaya Davydova, Ph.D., USP DQI or GPHF at the addresses shown below.
We look forward to hearing from you.
Yours sincerely,
Nancy L. Blum, M.P.H., M.A.
Vice President, International Affairs
Acting Director, USP Drug Quality and Information Program
12601 Twinbrook Parkway, Rockville, MD 20852, USA
uspdqi@usp.org
www.usp.org
T: 001-301-816-8160
F: 001-301-816-8374
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German Pharma Health Fund e.V.
Walther-von-Cronberg Platz 6
60594 Frankfurt, Germany,
www.gphf.org
Head Office:
T: +49-69-96238760-0
F: +49-69-96238760-9
info@gphf.org
Project Office:
T: +49-69-46939-662
F: +49-69-46939-852
richard.jaehnke@gphf.org