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[e-med] WHO Drug Information, Vol. 31, No. 2 vient de paraitre

(en anglais seulement mais c'est une revue de référence sur les 
médicaments...CB)

Le 07/07/2017 15:36, « e-drug-bounces@healthnet.org on behalf of
ZWEYGARTH@healthnet.org » <e-drug-bounces@healthnet.org on behalf of
ZWEYGARTH@healthnet.org> a écrit :


E-DRUG: WHO Drug Information, Vol. 31, No. 2 published
----------------------------------------------------------------------

Dear e-drug members,

The latest issue of WHO Drug Information (Vol. 31, No. 2) has just been
published on the WHO website and is available here:
http://www.who.int/medicines/publications/druginformation/issues/DrugInfor
mation2017_Vol31-2/en/


WHO Drug Information provides an overview of topics of current relevance
relating to drug development and regulation.


The second issue for 2017 includes the following:

Medicines regulation
"Regulating medicine manufacturers: is an on-site inspection the only
option?"
This paper describes the pathways used by the Australian Department of
Health's Therapeutic Goods Administration (TGA) for granting good
manufacturing practice (GMP) clearance.

"Placebo and drug kits in clinical trial design"
This paper summarizes some published information on two specific aspects
of conducting clinical studies: the use of placebo as a control
intervention and the use of drug kits for effective blinding of trials.


Quality monitoring
"Survey of the quality of selected antiretroviral medicines (ARVs)
circulating in five African countries"
This article summarizes the findings of an ARV sample testing survey
organized by WHO in 2015/16.


-----News 
The "Safety news" section highlights regulatory information on adverse
drug reactions as well as findings of non-compliance with good practices.
The "Regulatory news" section gives an overview of developments at
regulatory authorities, and lists approvals of new products. This is
followed by a section on "Publications and events" related to the access,
quality and use of medical products in WHO Member States.


-----Consultation documents
This section includes the following proposed texts for The International
Pharmacopoeia: draft monographs on mebendazole tablets, atenolol,
capreomycin sulfate and capreomycin for injection; a concept paper for
the transition from microbiological to physicochemical assays in
monographs on capreomycin active pharmaceutical ingredients and products;
and a text on capillary electrophoresis. A list is also provided of WHO
medicines quality guidelines that were recently posted for public comment.


-----ATC/DDD classification
This section presents the temporary and final lists intended for the
January 2018 Index of Anatomical Therapeutic Chemical (ATC)
classifications and Defined Daily Doses (DDD).


-----International Nonproprietary Names
Issue 2 concludes with List No. 117 of proposed International
Nonproprietary Names for Pharmaceutical Substances (INN).


Best regards,
Monika


Monika Zweygarth
WHO Essential Medicines and Health Products (EMP)
Alternative e-mail: zweygarthm.gmail.com
ZWEYGARTH, Monika <zweygarthm@who.int>


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