[e-drug] WHO Expert Committee on Specifications for Pharmaceutical Preparations

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: WHO Expert Committee on Specifications for Pharmaceutical Preparations
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[besides the well-known WHO Essential Medicines List committee (its 14th meeting planned for 7-11 March 2005, see 
www.who.int/medicines/organization/par/edl/expcom14/expertcomm14.shtml) there is also the much more technical WHO Expert Committee on Specifications for Pharmaceutical Preparations. 

Your E-drug moderator did not spot this page in time: the 39th meeting of this committee already took place 25-29 October. An overview of the agenda is below. It includes some important draft WHO guidelines (e.g. Fixed-Dose-Combinations), and also proposed pharmacopoeial standards for ARVs and TB drugs. Any e-drugger willing to review them?

All documents are downloadable from: http://www.who.int/medicines/organization/qsm/expert_committee/expertcomm.shtml
WB]

39th WHO Expert Committee on Specifications for Pharmaceutical Preparations, 25-29 October 2004

Draft Agenda 

Draft Guidelines
FDC -WHO-QAS04_108 
GMP_Herbal_RevJuly-04_QAS050 
Interchangeability-WHO-QAS_093Rev3_23Sept04 
QAS_055_Rev1_validation 
QAS_066_Rev3_sampling 
QAS_068_GDP 
QAS047_Rev1_Water 
Guidelines on MP HVAC (Rev 4) 

Discussion Papers
ARV_general_outline_EC04_6 
ARVmonographs_EC04_5 
Centre_Report_2003_EDMQSM2004_7 
Centre Report 002 
Comparator_products_add_EC04_7 
GMP_sampling_startmats_QAS04_110 
QAS_088_stability 
QAS_107_Jun04meetingreport_recommendations 
Waive_invivo_BE_QAS04_109 

Specifications

General
QAS 117 General Outline Monograph Development 
Requests development monographs EC 04 12 

ARVs
QAS116 Status ARV monograph development 
QAS_067_Rev2_didanosine_monograph_Sept2004 
QAS_072Rev2_indinavirsulfate_monograph_Sept2004 
QAS 082 nevirapine monograph Feb2004 
QAS_084_Rev2_nelfinavir_Monograph_Sept2004 
QAS_095_saquinavir_mesilate_monograph_Sept2004 
QAS_096_saquinavir_monograph_Sept2004 
QAS_111_Ritonavir_monograph_11Oct04 

TB
QAS_094_isoniazid_ethambutolHCl_monograph_13Oct04 
QAS_097_rifampicin_isoniazid_pyrazinamide_ethambutolHCl_monograph_13Oct04 
QAS_112_Rifampicin_tablets_monograph_12Oct04 
QAS_113_Rifampicin_capsules_monograph_12Oct04 
QAS_114_Rifampicin_Isoniazid_tablets_monograph_12Oct04 
QAS_115_Rifampicin_Isoniazid_Pyrazinamide_tablets_monograph_12Oct04 
QAS118 AntiTB BTs FDC development 
QAS119 

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Dr Wilbert Bannenberg, Public Health Consultant
Mobile +31-6-20873123
Tel work +31-497-550713
Fax +31-497-550712
Email: wjb@wxs.nl 
**please note: wilbertbannenberg@compuserve.com no longer valid**

**NEW** postal address:
Prins Bernhardstraat 1, 5571 GC Bergeyk, The Netherlands

Work website: www.herabelgium.com