Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects
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| Published in | Hepatology (Baltimore, Md.) Vol. 57; no. 3; pp. 903 - 907 |
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| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hoboken
Wiley Subscription Services, Inc., A Wiley Company
01.03.2013
Wolters Kluwer Health, Inc |
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| Author | Mishra, Poonam Florian, Jeffry Ayala, Ruben Amur, Shashi Robertson, Sarah Jadhav, Pravin R. Pacanowski, Michael Soon, Greg O'Rear, Jules Zeng, Wen Harrington, Patrick Murray, Jeffrey Singer, Mary |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22610696$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1056/NEJMoa1010494 10.2165/11593210-000000000-00000 10.1128/AAC.00667-09 10.1056/NEJMoa0808010 10.1056/NEJMoa1009482 |
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| Copyright | Copyright © 2012 American Association for the Study of Liver Diseases |
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| Notes | fax: (301)‐847‐8720 Disclaimer: the contents of the article represent the authors' personal opinion and do not necessarily reflect any position of the Food and Drug Administration. Potential conflict of interest: Nothing to report. Data for these analyses were submitted to the United States Food and Drug Administration by Merck as part of a new drug application. See Editorial on Page 875 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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| References | 2011 2010; 54 201131; 364 2011; 364 2009; 361 2011; 50 Poordad (R2-10-20241201) 201131; 364 Lee (R8-10-20241201) 2011; 50 Bacon (R3-10-20241201) 2011; 364 Li (R7-10-20241201) 2010; 54 McHutchison (R11-10-20241201) 2009; 361 23456679 - Hepatology. 2013 Mar;57(3):875-7 |
| References_xml | – year: 2011 – volume: 54 start-page: 375 year: 2010 end-page: 379 article-title: Pharmacometrics‐based dose selection of levofloxacin as a treatment for postexposure inhalation anthrax in children publication-title: Antimicrob Agents Chemother – article-title: Interferon responsiveness does not change in experienced hepatitis C subjects: implications for drug development and clinical decisions publication-title: HEPATOLOGY – volume: 364 start-page: 1207 year: 2011 end-page: 1217 article-title: Boceprevir for previously treated chronic HCV genotype 1 infection publication-title: N Engl J Med – volume: 361 start-page: 580 year: 2009 end-page: 593 article-title: Peginterferon alfa‐2b or alfa‐2a with ribavirin for treatment of hepatitis C infection publication-title: N Engl J Med – volume: 50 start-page: 627 year: 2011 end-page: 35 article-title: Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008 publication-title: Clin Pharmacokinet – volume: 364 start-page: 1195 year: 201131 end-page: 1206 article-title: Boceprevir for untreated chronic HCV genotype 1 infection publication-title: N Engl J Med – volume: 364 start-page: 1195 year: 201131 ident: R2-10-20241201 article-title: Boceprevir for untreated chronic HCV genotype 1 infection. publication-title: N Engl J Med doi: 10.1056/NEJMoa1010494 – volume: 50 start-page: 627 year: 2011 ident: R8-10-20241201 article-title: Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. publication-title: Clin Pharmacokinet doi: 10.2165/11593210-000000000-00000 – volume: 54 start-page: 375 year: 2010 ident: R7-10-20241201 article-title: Pharmacometricsbased dose selection of levofloxacin as a treatment for postexposure inhalation anthrax in children. publication-title: Antimicrob Agents Chemother doi: 10.1128/AAC.00667-09 – volume: 361 start-page: 580 year: 2009 ident: R11-10-20241201 article-title: Peginterferon alfa2b or alfa2a with ribavirin for treatment of hepatitis C infection. publication-title: N Engl J Med doi: 10.1056/NEJMoa0808010 – volume: 364 start-page: 1207 year: 2011 ident: R3-10-20241201 article-title: Boceprevir for previously treated chronic HCV genotype 1 infection. publication-title: N Engl J Med doi: 10.1056/NEJMoa1009482 – reference: 23456679 - Hepatology. 2013 Mar;57(3):875-7 |
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| Title | Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects |
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