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Within the framework of the Pilot Procurement Project for Quality and Sourcing of HIV Drugs (http://www.who.int/medicines), the International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality control laboratories, national and regional pharmacopoeial bodies, research, governments, and regulatory bodies to provide specifications and monographs for the following antiretroviral agents:
abacavir, didanosine, efavirenz, indinavir, lamivudine, nelfinavir, nevirapine, ritonavir, saquinavir, stavudine, zidovudine
Specifications for the respective dosage forms will be developed during a second phase of the project. The draft monographs, Indinavir sulfate, nelfinavir mesilate, and nevirapine are now available for consultation and are presented below. Comments should be sent to: Quality and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerland or kopps@who.int.
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