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Esomeprazole FDA Ap...
Esomeprazole FDA Approval in Children With GERD : Exposure-Matching and Exposure-Response
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- Earp, Justin C. (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Mehrotra, Nitin (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Peters, Kristina E. (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Fiorentino, Robert P. (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Griebel, Donna (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Lee, Sue C. (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Mulberg, Andrew (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Rohss, Kerstin (författare)
- Former Employee AstraZeneca R&D Molndal, Molndal, Sweden.
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- Sandstrom, Marie (författare)
- Former Employee AstraZeneca R&D Molndal, Molndal, Sweden.
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- Taylor, Amy (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- Tornoe, Christoffer W. (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.;Novo Nordisc, Aalborg, Denmark.
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- Wynn, Erica L. (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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- van der Walt, Jan-Stefan (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap,Astellas Pharma Europe BV, Global Clin Pharmacol & Exploratory Dev, Leiden, Netherlands.
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- Garnett, Christine (författare)
- US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA.
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US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 51,Rm 3154, Silver Spring, MD 20993 USA Former Employee AstraZeneca R&D Molndal, Molndal, Sweden. (creator_code:org_t)
- LIPPINCOTT WILLIAMS & WILKINS, 2017
- 2017
- Engelska.
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Ingår i: Journal of Pediatric Gastroenterology and Nutrition - JPGN. - : LIPPINCOTT WILLIAMS & WILKINS. - 0277-2116 .- 1536-4801. ; 65:3, s. 272-277
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Objectives: Food and Drug Administration approval of proton-pump inhibitors for infantile gastroesophageal reflux disease has been limited by intrapatient variability in the clinical assessment of gastroesophageal reflux disease. For children 1 to 17 years old, extrapolating efficacy from adults for IV esomeprazole was accepted. The oral formulation was previously approved in children. Exposure-response and exposure matching analyses were sought to identify approvable pediatric doses. Methods: Intragastric pH biomarker comparisons between children and adults were conducted. Pediatric doses were selected to match exposures in adults and were based on population pharmacokinetic (PK) modeling and simulations with pediatric esomeprazole data. Observed IV or oral esomeprazole PK data were available from 50 and 117 children, between birth and 17 years, respectively, and from 65 adults, between 20 and 48 years. A population PK model developed using these data was used to simulate steady-state esomeprazole exposures for children at different doses to match the observed exposures in adults. Results: Exposure-response relationships of intragastric pH measures were similar between children and adults. The PK simulations identified a dosing regimen for children that results in comparable steady-state area under the curve to that observed after 20 mg in adults. For IV esomeprazole, increasing the infusion duration to 10 to 30 minutes in children achieves matching C-max values with adults. Conclusions: The exposure-matching analysis permitted approval of an esomeprazole regimen not studied directly in clinical trials. Exposureresponse for intragastric pH-permitted approval for the treatment of gastroesophageal reflux disease in children in whom it was not possible to evaluate the adult primary endpoint, mucosal healing assessed by endoscopy.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Nyckelord
- biomarker
- esomeprazole
- exposure-matching
- exposure-response
- pediatric
- pharmacokinetics
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- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Earp, Justin C.
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Mehrotra, Nitin
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Peters, Kristina ...
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Fiorentino, Robe ...
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Griebel, Donna
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Lee, Sue C.
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visa fler...
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Mulberg, Andrew
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Rohss, Kerstin
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Sandstrom, Marie
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Taylor, Amy
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Tornoe, Christof ...
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Wynn, Erica L.
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van der Walt, Ja ...
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Garnett, Christi ...
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visa färre...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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Uppsala universitet