Who Drug Evaluation

In: Business and Management

Submitted By jcrrreddy
Words 17347
Pages 70


V O L U M E 10 N U M B E R 4 19 9 6










Volume 10, Number 4, 1996

World Health Organization, Geneva

WHO Drug Information
General Policy Topics
Meeting the challenge of biotechnology 175

Regulatory Matters
Acellular pertussis vaccine for infants Breath test for Helicobacter pylori Restrictions on use of anorectics Coumarin: regulatory action Laxatives: reclassification of common ingredients Is melatonin a prescription drug? NSAIDS, antimicrobials and angioedema Drug-induced liver disease Fluoxetine and hepatitis Hepatitis B vaccine and musculoskeletal reactions Pyrithyldione-diphenhydramine and agranulocytosis Roxithromycin associated with cardiac arrhythmias 187 187 187 188 189 189 189 189 190 190 190 190

Reports on Individual Drugs
Confirmation of increased chloroquine resistance in South Africa Which malaria drug for children? Post-malaria neurological syndrome and mefloquine Driving ability in cancer patients treated with morphine Hormone replacement therapy and venous thromboembolism 177 177 177 178 179

Safety Issues
Documentation requirements for approval: safety Drug safety monitoring centres 180 181

Recent Publications
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Thirty-fourth report International Nonproprietary Names (INN) for pharmaceutical substances: cumulative list No. 9 Good pharmacy practice (GPP) guidelines 191 192 192

General Information
Recommendations from the ICDRA reinforce the mission of regulatory authorities The International Pharmacopoeia — how useful is it? Reference preparations for the evaluation of diagnostic kits used in blood screening 182 186 186


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