Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs
Identifieur interne : 003A68 ( Main/Exploration ); précédent : 003A67; suivant : 003A69Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs
Auteurs : Brian Godman [Suède, Royaume-Uni] ; Rickard E. Malmström [Suède] ; Eduardo Diogene [Espagne] ; Sisira Jayathissa [Nouvelle-Zélande] ; Stuart Mctaggart [Royaume-Uni] ; Thomas Cars [Suède] ; Samantha Alvarez-Madrazo [Royaume-Uni] ; Christoph Baumg Rtel [Autriche] ; Anna Brzezinska [Pologne] ; Anna Bucsics [Autriche] ; Stephen Campbell [Royaume-Uni] ; Irene Eriksson [Suède] ; Alexander Finlayson [Royaume-Uni] ; Jurij Fürst [Slovénie] ; Kristina Garuoliene [Lituanie] ; I Aki Gutiérrez-Ibarluzea [Espagne] ; Krystyna Hviding [Norvège] ; Harald Herholz [Allemagne] ; Roberta Joppi [Italie] ; Marija Kalaba [Serbie] ; Ott Laius [Estonie] ; Kamila Malinowska [Pologne] ; Hanne B. Pedersen [Danemark] ; Vanda Markovic-Pekovic [Bosnie-Herzégovine] ; Jutta Piessnegger [Autriche] ; Gisbert Selke [Allemagne] ; Catherine Sermet [France] ; Susan Spillane [Irlande (pays)] ; Dominik Tomek [Slovaquie] ; Luka Von Ina [Croatie] ; Vera Vlahovi Pal Evski [Croatie] ; Janet Wale [Australie] ; Magdalena Wladysiuk [Pologne] ; Menno Van Woerkom [Pays-Bas] ; Corinne Zara [Espagne] ; Lars L. Gustafsson [Suède]Source :
- Frontiers in Pharmacology [ 1663-9812 ] ; 2014.
Abstract
Url:
DOI: 10.3389/fphar.2014.00109
PubMed: 24959145
PubMed Central: 4050532
Affiliations:
- Allemagne, Australie, Autriche, Bosnie-Herzégovine, Croatie, Danemark, Espagne, Estonie, France, Irlande (pays), Italie, Lituanie, Norvège, Nouvelle-Zélande, Pays-Bas, Pologne, Royaume-Uni, Serbie, Slovaquie, Slovénie, Suède
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Le document en format XML
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</nlm:aff>
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<country xml:lang="fr">Suède</country>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs</title>
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</nlm:aff>
<country xml:lang="fr">Suède</country>
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</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
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<author><name sortKey="Malmstrom, Rickard E" sort="Malmstrom, Rickard E" uniqKey="Malmstrom R" first="Rickard E." last="Malmström">Rickard E. Malmström</name>
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<country xml:lang="fr">Suède</country>
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</nlm:aff>
<country xml:lang="fr">Espagne</country>
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<author><name sortKey="Jayathissa, Sisira" sort="Jayathissa, Sisira" uniqKey="Jayathissa S" first="Sisira" last="Jayathissa">Sisira Jayathissa</name>
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</nlm:aff>
<country xml:lang="fr">Nouvelle-Zélande</country>
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<author><name sortKey="Mctaggart, Stuart" sort="Mctaggart, Stuart" uniqKey="Mctaggart S" first="Stuart" last="Mctaggart">Stuart Mctaggart</name>
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</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
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</author>
<author><name sortKey="Cars, Thomas" sort="Cars, Thomas" uniqKey="Cars T" first="Thomas" last="Cars">Thomas Cars</name>
<affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council</institution>
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</nlm:aff>
<country xml:lang="fr">Suède</country>
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</affiliation>
<affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Department of Medical Sciences, Uppsala University</institution>
<country>Uppsala, Sweden</country>
</nlm:aff>
<country xml:lang="fr">Suède</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
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<author><name sortKey="Alvarez Madrazo, Samantha" sort="Alvarez Madrazo, Samantha" uniqKey="Alvarez Madrazo S" first="Samantha" last="Alvarez-Madrazo">Samantha Alvarez-Madrazo</name>
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</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
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</author>
<author><name sortKey="Baumg Rtel, Christoph" sort="Baumg Rtel, Christoph" uniqKey="Baumg Rtel C" first="Christoph" last="Baumg Rtel">Christoph Baumg Rtel</name>
<affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Austrian Medicines and Medical Devices Agency</institution>
<country>Wien, Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Brzezinska, Anna" sort="Brzezinska, Anna" uniqKey="Brzezinska A" first="Anna" last="Brzezinska">Anna Brzezinska</name>
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<country>Warsaw, Poland</country>
</nlm:aff>
<country xml:lang="fr">Pologne</country>
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</affiliation>
</author>
<author><name sortKey="Bucsics, Anna" sort="Bucsics, Anna" uniqKey="Bucsics A" first="Anna" last="Bucsics">Anna Bucsics</name>
<affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Department of Finance, Faculty of Business, Economics and Statistics, University of Vienna</institution>
<country>Vienna, Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
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</affiliation>
<affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Hauptverband der Österreichischen Sozialversicherungsträger</institution>
<country>Vienna, Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Campbell, Stephen" sort="Campbell, Stephen" uniqKey="Campbell S" first="Stephen" last="Campbell">Stephen Campbell</name>
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<country>Manchester, UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
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</affiliation>
</author>
<author><name sortKey="Eriksson, Irene" sort="Eriksson, Irene" uniqKey="Eriksson I" first="Irene" last="Eriksson">Irene Eriksson</name>
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<country>Stockholm, Sweden</country>
</nlm:aff>
<country xml:lang="fr">Suède</country>
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<author><name sortKey="Finlayson, Alexander" sort="Finlayson, Alexander" uniqKey="Finlayson A" first="Alexander" last="Finlayson">Alexander Finlayson</name>
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<country>Oxford, UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
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</author>
<author><name sortKey="Furst, Jurij" sort="Furst, Jurij" uniqKey="Furst J" first="Jurij" last="Fürst">Jurij Fürst</name>
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</nlm:aff>
<country xml:lang="fr">Slovénie</country>
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<author><name sortKey="Garuoliene, Kristina" sort="Garuoliene, Kristina" uniqKey="Garuoliene K" first="Kristina" last="Garuoliene">Kristina Garuoliene</name>
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</nlm:aff>
<country xml:lang="fr">Lituanie</country>
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</author>
<author><name sortKey="Gutierrez Ibarluzea, I Aki" sort="Gutierrez Ibarluzea, I Aki" uniqKey="Gutierrez Ibarluzea I" first="I Aki" last="Gutiérrez-Ibarluzea">I Aki Gutiérrez-Ibarluzea</name>
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</nlm:aff>
<country xml:lang="fr">Espagne</country>
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</author>
<author><name sortKey="Hviding, Krystyna" sort="Hviding, Krystyna" uniqKey="Hviding K" first="Krystyna" last="Hviding">Krystyna Hviding</name>
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</nlm:aff>
<country xml:lang="fr">Norvège</country>
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</affiliation>
</author>
<author><name sortKey="Herholz, Harald" sort="Herholz, Harald" uniqKey="Herholz H" first="Harald" last="Herholz">Harald Herholz</name>
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</nlm:aff>
<country xml:lang="fr">Allemagne</country>
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</author>
<author><name sortKey="Joppi, Roberta" sort="Joppi, Roberta" uniqKey="Joppi R" first="Roberta" last="Joppi">Roberta Joppi</name>
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</nlm:aff>
<country xml:lang="fr">Italie</country>
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</affiliation>
</author>
<author><name sortKey="Kalaba, Marija" sort="Kalaba, Marija" uniqKey="Kalaba M" first="Marija" last="Kalaba">Marija Kalaba</name>
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</nlm:aff>
<country xml:lang="fr">Serbie</country>
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</author>
<author><name sortKey="Laius, Ott" sort="Laius, Ott" uniqKey="Laius O" first="Ott" last="Laius">Ott Laius</name>
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</nlm:aff>
<country xml:lang="fr">Estonie</country>
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</author>
<author><name sortKey="Malinowska, Kamila" sort="Malinowska, Kamila" uniqKey="Malinowska K" first="Kamila" last="Malinowska">Kamila Malinowska</name>
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</nlm:aff>
<country xml:lang="fr">Pologne</country>
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<affiliation wicri:level="1"><nlm:aff id="aff24"><institution>Drug Management Department, National Health Fund</institution>
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</nlm:aff>
<country xml:lang="fr">Pologne</country>
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<author><name sortKey="Pedersen, Hanne B" sort="Pedersen, Hanne B" uniqKey="Pedersen H" first="Hanne B." last="Pedersen">Hanne B. Pedersen</name>
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</nlm:aff>
<country xml:lang="fr">Danemark</country>
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<author><name sortKey="Markovic Pekovic, Vanda" sort="Markovic Pekovic, Vanda" uniqKey="Markovic Pekovic V" first="Vanda" last="Markovic-Pekovic">Vanda Markovic-Pekovic</name>
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<country xml:lang="fr">Bosnie-Herzégovine</country>
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<affiliation wicri:level="1"><nlm:aff id="aff27"><institution>Ministry of Health and Social Welfare</institution>
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</nlm:aff>
<country xml:lang="fr">Bosnie-Herzégovine</country>
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<author><name sortKey="Piessnegger, Jutta" sort="Piessnegger, Jutta" uniqKey="Piessnegger J" first="Jutta" last="Piessnegger">Jutta Piessnegger</name>
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</nlm:aff>
<country xml:lang="fr">Autriche</country>
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</author>
<author><name sortKey="Selke, Gisbert" sort="Selke, Gisbert" uniqKey="Selke G" first="Gisbert" last="Selke">Gisbert Selke</name>
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</nlm:aff>
<country xml:lang="fr">Allemagne</country>
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<wicri:noRegion>USA. Baltimore</wicri:noRegion>
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</author>
<author><name sortKey="Sermet, Catherine" sort="Sermet, Catherine" uniqKey="Sermet C" first="Catherine" last="Sermet">Catherine Sermet</name>
<affiliation wicri:level="1"><nlm:aff id="aff29"><institution>IRDES</institution>
<country>Paris, France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Spillane, Susan" sort="Spillane, Susan" uniqKey="Spillane S" first="Susan" last="Spillane">Susan Spillane</name>
<affiliation wicri:level="1"><nlm:aff id="aff30"><institution>Department of Pharmacology and Therapeutics, Trinity College Dublin</institution>
<country>Dublin, Ireland</country>
</nlm:aff>
<country xml:lang="fr">Irlande (pays)</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tomek, Dominik" sort="Tomek, Dominik" uniqKey="Tomek D" first="Dominik" last="Tomek">Dominik Tomek</name>
<affiliation wicri:level="1"><nlm:aff id="aff31"><institution>Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University</institution>
<country>Bratislava, Slovakia</country>
</nlm:aff>
<country xml:lang="fr">Slovaquie</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Von Ina, Luka" sort="Von Ina, Luka" uniqKey="Von Ina L" first="Luka" last="Von Ina">Luka Von Ina</name>
<affiliation wicri:level="1"><nlm:aff id="aff32"><institution>Ministry of Health</institution>
<country>Zagreb, Croatia</country>
</nlm:aff>
<country xml:lang="fr">Croatie</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Vlahovi Pal Evski, Vera" sort="Vlahovi Pal Evski, Vera" uniqKey="Vlahovi Pal Evski V" first="Vera" last="Vlahovi Pal Evski">Vera Vlahovi Pal Evski</name>
<affiliation wicri:level="1"><nlm:aff id="aff33"><institution>Unit for Clinical Pharmacology, University Hospital Rijeka</institution>
<country>Rijeka, Croatia</country>
</nlm:aff>
<country xml:lang="fr">Croatie</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wale, Janet" sort="Wale, Janet" uniqKey="Wale J" first="Janet" last="Wale">Janet Wale</name>
<affiliation wicri:level="1"><nlm:aff id="aff34"><institution>Independent Consumer Advocate, VIC</institution>
<country>Melbourne, Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wladysiuk, Magdalena" sort="Wladysiuk, Magdalena" uniqKey="Wladysiuk M" first="Magdalena" last="Wladysiuk">Magdalena Wladysiuk</name>
<affiliation wicri:level="1"><nlm:aff id="aff35"><institution>HTA Consulting</institution>
<country>Cracow, Poland</country>
</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Van Woerkom, Menno" sort="Van Woerkom, Menno" uniqKey="Van Woerkom M" first="Menno" last="Van Woerkom">Menno Van Woerkom</name>
<affiliation wicri:level="1"><nlm:aff id="aff36"><institution>Dutch Institute for Rational Use of Medicine</institution>
<country>Utrecht, Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Zara, Corinne" sort="Zara, Corinne" uniqKey="Zara C" first="Corinne" last="Zara">Corinne Zara</name>
<affiliation wicri:level="1"><nlm:aff id="aff37"><institution>Barcelona Health Region, Catalan Health Service</institution>
<country>Barcelona, Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gustafsson, Lars L" sort="Gustafsson, Lars L" uniqKey="Gustafsson L" first="Lars L." last="Gustafsson">Lars L. Gustafsson</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge</institution>
<country>Stockholm, Sweden</country>
</nlm:aff>
<country xml:lang="fr">Suède</country>
<wicri:regionArea>Program in Personalized Medicine, Division of Endocrinology, Diabetes and Nutrition - University of Maryland School of Medicine, USA. Baltimore</wicri:regionArea>
<wicri:noRegion>USA. Baltimore</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">Frontiers in Pharmacology</title>
<idno type="eISSN">1663-9812</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><bold>Background</bold>
: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.</p>
<p><bold>Objective</bold>
: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities.</p>
<p><bold>Methodology</bold>
: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies.</p>
<p><bold>Results</bold>
: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice.</p>
<p><bold>Conclusion</bold>
: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.</p>
</div>
</front>
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</back>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Bosnie-Herzégovine</li>
<li>Croatie</li>
<li>Danemark</li>
<li>Espagne</li>
<li>Estonie</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Italie</li>
<li>Lituanie</li>
<li>Norvège</li>
<li>Nouvelle-Zélande</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>Serbie</li>
<li>Slovaquie</li>
<li>Slovénie</li>
<li>Suède</li>
</country>
</list>
<tree><country name="Suède"><noRegion><name sortKey="Godman, Brian" sort="Godman, Brian" uniqKey="Godman B" first="Brian" last="Godman">Brian Godman</name>
</noRegion>
<name sortKey="Cars, Thomas" sort="Cars, Thomas" uniqKey="Cars T" first="Thomas" last="Cars">Thomas Cars</name>
<name sortKey="Cars, Thomas" sort="Cars, Thomas" uniqKey="Cars T" first="Thomas" last="Cars">Thomas Cars</name>
<name sortKey="Eriksson, Irene" sort="Eriksson, Irene" uniqKey="Eriksson I" first="Irene" last="Eriksson">Irene Eriksson</name>
<name sortKey="Gustafsson, Lars L" sort="Gustafsson, Lars L" uniqKey="Gustafsson L" first="Lars L." last="Gustafsson">Lars L. Gustafsson</name>
<name sortKey="Malmstrom, Rickard E" sort="Malmstrom, Rickard E" uniqKey="Malmstrom R" first="Rickard E." last="Malmström">Rickard E. Malmström</name>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Godman, Brian" sort="Godman, Brian" uniqKey="Godman B" first="Brian" last="Godman">Brian Godman</name>
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<name sortKey="Campbell, Stephen" sort="Campbell, Stephen" uniqKey="Campbell S" first="Stephen" last="Campbell">Stephen Campbell</name>
<name sortKey="Finlayson, Alexander" sort="Finlayson, Alexander" uniqKey="Finlayson A" first="Alexander" last="Finlayson">Alexander Finlayson</name>
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</country>
<country name="Espagne"><noRegion><name sortKey="Diogene, Eduardo" sort="Diogene, Eduardo" uniqKey="Diogene E" first="Eduardo" last="Diogene">Eduardo Diogene</name>
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