Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3 Suppl
pubmed:dateCreated
1999-5-6
pubmed:abstractText
In many African countries, the first step for introducing a new drug is its selection on the Essential Drug List (WHO) according to the need, the efficacy, the safety, and the affordability of the product. Requirements for registration of artemisinin and its derivatives are either simple notification or authorization, or full registration. Procedures may vary from country to country, depending upon the level of development of their national regulatory system. The availability of mechanisms to regulate the distribution and the use of these new antimalarials are also depending upon the availability of manpower to implement them. The only artemisinin derivative which has been evaluated clinically in Africa and registered in some African countries, for the treatment of severe and complicated malaria, is intramuscular (i.m.) artemether. The major advantage of artemether is that it is given i.m., thus can be used at peripheral facilities where treatment with intravenous infusions of quinine would not be possible. Post registration surveillance, while being a component of the drug policy of some African countries, has not yet been adequately managed.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0025-682X
pubmed:author
pubmed:issnType
Print
pubmed:volume
58
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
82-4
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
1998
pubmed:articleTitle
Artemisinin and its derivatives: the regulatory and policy implications for African countries.
pubmed:affiliation
Nigerian Institute of Medical Research, Lagos, Nigeria.
pubmed:publicationType
Journal Article