E-DRUG: WHO Drug Information - Launch of Table of Contents Service
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Dear Readers,
WHO DRUG INFORMATION is a quarterly subscription journal published by
WHO since 1987. Its objective is to bring medicines and pharmaceutical
issues to the attention of a wide audience of regulators, manufacturers,
health professionals and policy makers. Reliable information is of
particular importance in supporting health-related decisions and
strengthening the rational use of drugs.
WHO DRUG INFORMATION highlights topics of current concern, recent
regulatory decisions and standard-setting activities, with a focus on
the processes linking regulatory activity to therapeutic practice. It
presents selected contributions portraying a variety of viewpoints from
different disciplines and pharmaceutical sciences.
A table of contents service has now been launched for WHO DRUG
INFORMATION. To join the list, please send an e-mail to LISTSERV@WHO.INT
with the message text: subscribe DRUGINFORMATION.
Christine Encrenaz
Quality and Safety: Medicines
Department of Medicines Policy and Standards
World Health Organization
1211 Geneva 27
encrenazc@who.int
http://www.who.int/druginformation
http://www.who.int/medicines/icdra.shtml
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WHO DRUG INFORMATION, Volume 19 Number 1
The latest version of WHO DRUG INFORMATION presents an introductory
article on the use of genomics in drug development and possibilities for
individually targeted therapy. It explores the opportunities which this
new area opens for risk reduction and describes the challenges facing
researchers in demonstrating clinical validity and the role of the
regulatory community in evaluating safety and efficacy.
Latest Developments in Biological Standardization is an overview of work
assessed and recommendations made by the WHO Expert Committee on
Biological Standardization, including International Reference Standards
and Guidelines, and new or replacement standards established by the
Committee.
The Safety and Efficacy section continues to give the latest information
on safety signals and reports of adverse drug reactions, with other
safety news from around the world, including an overview of how the WHO
International Drug Monitoring Programme operates. This information is
complemented by the section on Regulatory Action which provides a
snapshot of recent decisions from regulatory authorities.
An article describing the WHO Prequalification Project gives handy
information on how potential suppliers of essential medicines can apply
for prequalification of manufacturing sites and products and the series
of requirements needed for compliance.
Other useful information is provided on WHO's normative activities
including latest lists of ATC/DDD and recommended International
Nonproprietary Names (INN). Draft and final International Pharmacopoeia
monographs on didanosine, indinavir, nelfinavir, ritonavir and
saquainavir complete this issue of the journal.
This issue and back numbers can be viewed at www.who.int/druginformation
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Table of Contents www.who.int/druginformation
Current Topics
Pharmacogenetics: towards improving treatment with medicines
Abnormal drug response: opportunities for risk reduction through pharmacogenetics
Safety and Efficacy Issues
The role of pharmacovigilance in medicines safety
National Centres discuss new safety monitoring methods
Signaling and safety problems
Third meeting of the Signal Review Panel
COX-2 inhibitors: overview
Telithromycin and warfarin: suspected interaction
Penicillin: information strengthened
Linezolid and neuropathy
Ceftriaxone and immune haemolytic anaemia in children
Ethinylestradiol/cyproterone: increased risk of thrombosis
Influenza virus vaccine: interactions
Rosiglitazone and pioglitazone: dangers of off-label use
Naproxen and celecoxib suspended in Alzheimer prevention trial
Heparin contraindicated in severe renal impairment
Flucloxacillin: serious hepatic disorders
Bevacizumab and arterial thromboembolic events
Amiodarone toxicity concerns
Darbepoetin alfa: adverse outcomes
Vaccines and Biomedicines
Latest developments in biological standardization
International Reference Standards
Recommendations and guidelines
Consolidated list of WHO recommendations and guidelines
Regulatory Action
Northern hemisphere influenza vaccine composition 2005/2006
Valdecoxib: severe skin reactions and cardiovascular risk
COX-2 inhibitors: review plans
Co-proxamol products withdrawn
Cisapride licences voluntarily cancelled
Tentative approval for generic co-packaged antiretrovirals
Natalizumab approved for multiple sclerosis
Pegaptanib for age-related macular degeneration
Amphetamine salts suspended
Tolcapone: return to market
Patient reporting and public access to safety data
Australia and Canada agree mutual recognition
Didanosine-tenofovir interactions: safety recommendations
Prequalification of Medicines
Improving medicines quality through prequalification
How to participate in prequalification
ATC/DDD Classification
Final list
Temporary list
The International Pharmacopoeia
Monographs for antiretrovirals
Didanosine (final)
Indinavir sulfate (final)
Nelfinavir mesilate (final)
Ritonavir (final)
Saquinavir (final)
Saquinavir mesilate (final)
Recommended International Nonproprietary Names: List 53