E-DRUG: pharmacopoeial monograph of ARVs? (3)
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The issue of monographs for ARVs is important, to allow independent labs to
verify the quality of products. Here a contribution from WHO. WB]
In reply to Dr Segun Zaccheaus's message, we would like to inform you that
the World Health Organization is working on monographs for antiretrovirals
for inclusion in The International Pharmacopoeia. This work is carried out
with the collaboration of experts and producers around the globe.
Draft monographs on didanosine (second draft), indinavir sulfate,
nelfinavir mesilate and nevirapine have been developed by this international
group. They have been mailed to a wider panel of experts and laboratories
for comments and international validation. These monographs are based on
information and samples received from a large number of manufacturers
worldwide. It is intended to be fit for use for multisource products traded
internationally.
The first draft specifications for didanosine have been published for
additional comments in WHO Drug Information (Vol. 17, N� 3, pp. 165-168,
2003). This publication is also available at the following website address:
http://www.who.int/druginformation/vol17num3_2003/17-3.pdf. The others
listed above will be available shortly in the same manner.
Further draft monographs in this series of antiretrovirals will follow.
Dr Sabine Kopp
Quality Assurance & Safety: Medicines
Department of Essential Drugs and Medicines Policy
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Switzerland
Fax: +41 22 791 4730
Email: kopps@who.int
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