Ensuring supplies of quality diethylcarbamazine citrate (DEC).
Identifieur interne : 003D92 ( PubMed/Checkpoint ); précédent : 003D91; suivant : 003D93Ensuring supplies of quality diethylcarbamazine citrate (DEC).
Auteurs : Mary Ellen Kitler [Suisse] ; Nevio ZagariaSource :
- Journal of clinical pharmacology [ 0091-2700 ] ; 2003.
Descripteurs français
- KwdFr :
- Chromatographie en phase liquide à haute performance, Comprimés, Contrôle de qualité, Diéthylcarbamazine (analyse), Diéthylcarbamazine (normes), Filaricides (analyse), Filaricides (normes), Filariose lymphatique (traitement médicamenteux), Filariose lymphatique (épidémiologie), Industrie pharmaceutique (normes), Lutte contre l'infection, Organisation mondiale de la santé, Pharmacopées comme sujet, Stabilité de médicament.
- MESH :
- analyse : Diéthylcarbamazine, Filaricides.
- normes : Diéthylcarbamazine, Filaricides, Industrie pharmaceutique.
- traitement médicamenteux : Filariose lymphatique.
- épidémiologie : Filariose lymphatique.
- Chromatographie en phase liquide à haute performance, Comprimés, Contrôle de qualité, Lutte contre l'infection, Organisation mondiale de la santé, Pharmacopées comme sujet, Stabilité de médicament.
English descriptors
- KwdEn :
- Chromatography, High Pressure Liquid, Diethylcarbamazine (analysis), Diethylcarbamazine (standards), Drug Industry (standards), Drug Stability, Elephantiasis, Filarial (drug therapy), Elephantiasis, Filarial (epidemiology), Filaricides (analysis), Filaricides (standards), Infection Control, Pharmacopoeias as Topic, Quality Control, Tablets, World Health Organization.
- MESH :
- chemical , analysis : Diethylcarbamazine, Filaricides.
- chemical , standards : Diethylcarbamazine, Filaricides.
- drug therapy : Elephantiasis, Filarial.
- epidemiology : Elephantiasis, Filarial.
- standards : Drug Industry.
- Chromatography, High Pressure Liquid, Drug Stability, Infection Control, Pharmacopoeias as Topic, Quality Control, Tablets, World Health Organization.
Abstract
In 1997, the World Health Organization (WHO) made a commitment to eliminate lymphatic filariasis. The WHO Global Program to Eliminate Lymphatic Filariasis (WHO-FIL) needed a reliable supply of diethylcarbamazine citrate (DEC) of known acceptable quality at an affordable price, so in August 1999, it started the DEC Project. Today's standards required development of a modern stability-indicating assay method for DEC and for DEC tablet dissolution. ADD Advanced Drug Delivery Technologies (Switzerland) developed a high-pressure liquid chromatography assay, which was independently validated and is in the United States Pharmacopoeia 25 (2002). After a global search, the project found that almost all existing and potential DEC active pharmaceutical ingredient (API) and tablet manufacturers are in low-income countries. The project constructed an audit team to conduct on-site audits to assess good manufacturing practices according to European Union standards. National/state inspectors accompany the audit team. The team prequalified one DEC API manufacturer and three DEC tablet manufacturers. The project plans to increase the number of prequalified DEC manufacturers. Now, WHO-FIL only purchases from prequalified manufacturers. Consolidation of several national program DEC requirements into a limited international competitive bid reduced the price for DEC tablets between 30% and 45%, compared to previous small-scale WHO purchases.
PubMed: 12751269
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comme sujet</term><term>Stabilité de médicament</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In 1997, the World Health Organization (WHO) made a commitment to eliminate lymphatic filariasis. The WHO Global Program to Eliminate Lymphatic Filariasis (WHO-FIL) needed a reliable supply of diethylcarbamazine citrate (DEC) of known acceptable quality at an affordable price, so in August 1999, it started the DEC Project. Today's standards required development of a modern stability-indicating assay method for DEC and for DEC tablet dissolution. ADD Advanced Drug Delivery Technologies (Switzerland) developed a high-pressure liquid chromatography assay, which was independently validated and is in the United States Pharmacopoeia 25 (2002). After a global search, the project found that almost all existing and potential DEC active pharmaceutical ingredient (API) and tablet manufacturers are in low-income countries. The project constructed an audit team to conduct on-site audits to assess good manufacturing practices according to European Union standards. National/state inspectors accompany the audit team. The team prequalified one DEC API manufacturer and three DEC tablet manufacturers. The project plans to increase the number of prequalified DEC manufacturers. Now, WHO-FIL only purchases from prequalified manufacturers. Consolidation of several national program DEC requirements into a limited international competitive bid reduced the price for DEC tablets between 30% and 45%, compared to previous small-scale WHO purchases.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">12751269</PMID><DateCreated><Year>2003</Year><Month>05</Month><Day>19</Day></DateCreated><DateCompleted><Year>2003</Year><Month>08</Month><Day>18</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0091-2700</ISSN><JournalIssue CitedMedium="Print"><Volume>43</Volume><Issue>5</Issue><PubDate><Year>2003</Year><Month>May</Month></PubDate></JournalIssue><Title>Journal of clinical pharmacology</Title><ISOAbbreviation>J Clin Pharmacol</ISOAbbreviation></Journal><ArticleTitle>Ensuring supplies of quality diethylcarbamazine citrate (DEC).</ArticleTitle><Pagination><MedlinePgn>477-90</MedlinePgn></Pagination><Abstract><AbstractText>In 1997, the World Health Organization (WHO) made a commitment to eliminate lymphatic filariasis. The WHO Global Program to Eliminate Lymphatic Filariasis (WHO-FIL) needed a reliable supply of diethylcarbamazine citrate (DEC) of known acceptable quality at an affordable price, so in August 1999, it started the DEC Project. Today's standards required development of a modern stability-indicating assay method for DEC and for DEC tablet dissolution. ADD Advanced Drug Delivery Technologies (Switzerland) developed a high-pressure liquid chromatography assay, which was independently validated and is in the United States Pharmacopoeia 25 (2002). After a global search, the project found that almost all existing and potential DEC active pharmaceutical ingredient (API) and tablet manufacturers are in low-income countries. The project constructed an audit team to conduct on-site audits to assess good manufacturing practices according to European Union standards. National/state inspectors accompany the audit team. The team prequalified one DEC API manufacturer and three DEC tablet manufacturers. The project plans to increase the number of prequalified DEC manufacturers. Now, WHO-FIL only purchases from prequalified manufacturers. Consolidation of several national program DEC requirements into a limited international competitive bid reduced the price for DEC tablets between 30% and 45%, compared to previous small-scale WHO purchases.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kitler</LastName><ForeName>Mary Ellen</ForeName><Initials>ME</Initials><AffiliationInfo><Affiliation>DEC Project, WHO Global Program to Eliminate Lymphatic Filariasis, Strategy Development and Monitoring for Eradication and Elimination (CEE), Control, Prevention, and Eradication (CPE), World Health Organization, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zagaria</LastName><ForeName>Nevio</ForeName><Initials>N</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Clin Pharmacol</MedlineTA><NlmUniqueID>0366372</NlmUniqueID><ISSNLinking>0091-2700</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005369">Filaricides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013607">Tablets</NameOfSubstance></Chemical><Chemical><RegistryNumber>V867Q8X3ZD</RegistryNumber><NameOfSubstance UI="D004049">Diethylcarbamazine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D002851" MajorTopicYN="N">Chromatography, High Pressure Liquid</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004049" MajorTopicYN="N">Diethylcarbamazine</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004345" MajorTopicYN="N">Drug Industry</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004355" MajorTopicYN="N">Drug Stability</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004605" MajorTopicYN="N">Elephantiasis, Filarial</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005369" MajorTopicYN="N">Filaricides</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017053" MajorTopicYN="N">Infection Control</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010602" MajorTopicYN="N">Pharmacopoeias as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011786" MajorTopicYN="N">Quality Control</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013607" MajorTopicYN="N">Tablets</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014944" MajorTopicYN="N">World Health Organization</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2003</Year><Month>5</Month><Day>20</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2003</Year><Month>8</Month><Day>19</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2003</Year><Month>5</Month><Day>20</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">12751269</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Suisse</li></country></list><tree><noCountry><name sortKey="Zagaria, Nevio" sort="Zagaria, Nevio" uniqKey="Zagaria N" first="Nevio" last="Zagaria">Nevio Zagaria</name></noCountry><country name="Suisse"><noRegion><name sortKey="Kitler, Mary Ellen" sort="Kitler, Mary Ellen" uniqKey="Kitler M" first="Mary Ellen" last="Kitler">Mary Ellen Kitler</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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