Literature DB >> 25449025

Building bridges and providing transparency to the hepatitis C virus drug approval process.

Marc G Ghany1, T Jake Liang1.   

Abstract

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Year:  2014        PMID： 25449025      PMCID： PMC6299446          DOI： 10.1053/j.gastro.2014.10.028

Source DB:  PubMed          Journal:  Gastroenterology        ISSN： 0016-5085            Impact factor:   22.682


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  14 in total

1.  Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects.

Authors:  Jiang Liu; Pravin R Jadhav; Shashi Amur; Russell Fleischer; Thomas Hammerstrom; Linda Lewis; Lisa Naeger; Jule O'Rear; Michael Pacanowski; Sarah Robertson; Shirley Seo; Greg Soon; Debra Birnkrant
Journal:  Hepatology       Date:  2012-12-28       Impact factor: 17.425

2.  Boceprevir dosing for late responders and null responders: the role of bridging data between treatment-naïve and -experienced subjects.

Authors:  Jeffry Florian; Pravin R Jadhav; Shashi Amur; Ruben Ayala; Patrick Harrington; Poonam Mishra; Jules O'Rear; Michael Pacanowski; Sarah Robertson; Mary Singer; Greg Soon; Wen Zeng; Jeffrey Murray
Journal:  Hepatology       Date:  2013-01-29       Impact factor: 17.425

3.  Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

Authors:  Joo Yeon Lee; Christine E Garnett; Jogarao V S Gobburu; Venkatesh A Bhattaram; Satjit Brar; Justin C Earp; Pravin R Jadhav; Kevin Krudys; Lawrence J Lesko; Fang Li; Jiang Liu; Rajnikanth Madabushi; Anshu Marathe; Nitin Mehrotra; Christoffer Tornoe; Yaning Wang; Hao Zhu
Journal:  Clin Pharmacokinet       Date:  2011-10       Impact factor: 6.447

4.  Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response.

Authors:  John M Vierling; Mitchell Davis; Steven Flamm; Stuart C Gordon; Eric Lawitz; Eric M Yoshida; Joseph Galati; Velimir Luketic; Jonathan McCone; Ira Jacobson; Patrick Marcellin; Andrew J Muir; Fred Poordad; Lisa D Pedicone; Janice Albrecht; Clifford Brass; Anita Y M Howe; Lynn Y Colvard; Frans A Helmond; Weiping Deng; Michelle Treitel; Janice Wahl; Jean-Pierre Bronowicki
Journal:  J Hepatol       Date:  2013-12-19       Impact factor: 25.083

5.  Similar effectiveness of boceprevir and telaprevir treatment regimens for hepatitis C virus infection on the basis of a nationwide study of veterans.

Authors:  George N Ioannou; Lauren A Beste; Pamela K Green
Journal:  Clin Gastroenterol Hepatol       Date:  2013-12-17       Impact factor: 11.382

6.  Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression.

Authors:  Gary L Davis; Miriam J Alter; Hashem El-Serag; Thierry Poynard; Linda W Jennings
Journal:  Gastroenterology       Date:  2009-10-25       Impact factor: 22.682

7.  Sofosbuvir for previously untreated chronic hepatitis C infection.

Authors:  Eric Lawitz; Alessandra Mangia; David Wyles; Maribel Rodriguez-Torres; Tarek Hassanein; Stuart C Gordon; Michael Schultz; Mitchell N Davis; Zeid Kayali; K Rajender Reddy; Ira M Jacobson; Kris V Kowdley; Lisa Nyberg; G Mani Subramanian; Robert H Hyland; Sarah Arterburn; Deyuan Jiang; John McNally; Diana Brainard; William T Symonds; John G McHutchison; Aasim M Sheikh; Zobair Younossi; Edward J Gane
Journal:  N Engl J Med       Date:  2013-04-23       Impact factor: 91.245

8.  Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children.

Authors:  Fang Li; Partha Nandy; Shuchean Chien; Gary J Noel; Christoffer W Tornoe
Journal:  Antimicrob Agents Chemother       Date:  2009-10-26       Impact factor: 5.191

9.  Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010.

Authors:  Rafael Lozano; Mohsen Naghavi; Kyle Foreman; Stephen Lim; Kenji Shibuya; Victor Aboyans; Jerry Abraham; Timothy Adair; Rakesh Aggarwal; Stephanie Y Ahn; Miriam Alvarado; H Ross Anderson; Laurie M Anderson; Kathryn G Andrews; Charles Atkinson; Larry M Baddour; Suzanne Barker-Collo; David H Bartels; Michelle L Bell; Emelia J Benjamin; Derrick Bennett; Kavi Bhalla; Boris Bikbov; Aref Bin Abdulhak; Gretchen Birbeck; Fiona Blyth; Ian Bolliger; Soufiane Boufous; Chiara Bucello; Michael Burch; Peter Burney; Jonathan Carapetis; Honglei Chen; David Chou; Sumeet S Chugh; Luc E Coffeng; Steven D Colan; Samantha Colquhoun; K Ellicott Colson; John Condon; Myles D Connor; Leslie T Cooper; Matthew Corriere; Monica Cortinovis; Karen Courville de Vaccaro; William Couser; Benjamin C Cowie; Michael H Criqui; Marita Cross; Kaustubh C Dabhadkar; Nabila Dahodwala; Diego De Leo; Louisa Degenhardt; Allyne Delossantos; Julie Denenberg; Don C Des Jarlais; Samath D Dharmaratne; E Ray Dorsey; Tim Driscoll; Herbert Duber; Beth Ebel; Patricia J Erwin; Patricia Espindola; Majid Ezzati; Valery Feigin; Abraham D Flaxman; Mohammad H Forouzanfar; Francis Gerry R Fowkes; Richard Franklin; Marlene Fransen; Michael K Freeman; Sherine E Gabriel; Emmanuela Gakidou; Flavio Gaspari; Richard F Gillum; Diego Gonzalez-Medina; Yara A Halasa; Diana Haring; James E Harrison; Rasmus Havmoeller; Roderick J Hay; Bruno Hoen; Peter J Hotez; Damian Hoy; Kathryn H Jacobsen; Spencer L James; Rashmi Jasrasaria; Sudha Jayaraman; Nicole Johns; Ganesan Karthikeyan; Nicholas Kassebaum; Andre Keren; Jon-Paul Khoo; Lisa Marie Knowlton; Olive Kobusingye; Adofo Koranteng; Rita Krishnamurthi; Michael Lipnick; Steven E Lipshultz; Summer Lockett Ohno; Jacqueline Mabweijano; Michael F MacIntyre; Leslie Mallinger; Lyn March; Guy B Marks; Robin Marks; Akira Matsumori; Richard Matzopoulos; Bongani M Mayosi; John H McAnulty; Mary M McDermott; John McGrath; George A Mensah; Tony R Merriman; Catherine Michaud; Matthew Miller; Ted R Miller; Charles Mock; Ana Olga Mocumbi; Ali A Mokdad; Andrew Moran; Kim Mulholland; M Nathan Nair; Luigi Naldi; K M Venkat Narayan; Kiumarss Nasseri; Paul Norman; Martin O'Donnell; Saad B Omer; Katrina Ortblad; Richard Osborne; Doruk Ozgediz; Bishnu Pahari; Jeyaraj Durai Pandian; Andrea Panozo Rivero; Rogelio Perez Padilla; Fernando Perez-Ruiz; Norberto Perico; David Phillips; Kelsey Pierce; C Arden Pope; Esteban Porrini; Farshad Pourmalek; Murugesan Raju; Dharani Ranganathan; Jürgen T Rehm; David B Rein; Guiseppe Remuzzi; Frederick P Rivara; Thomas Roberts; Felipe Rodriguez De León; Lisa C Rosenfeld; Lesley Rushton; Ralph L Sacco; Joshua A Salomon; Uchechukwu Sampson; Ella Sanman; David C Schwebel; Maria Segui-Gomez; Donald S Shepard; David Singh; Jessica Singleton; Karen Sliwa; Emma Smith; Andrew Steer; Jennifer A Taylor; Bernadette Thomas; Imad M Tleyjeh; Jeffrey A Towbin; Thomas Truelsen; Eduardo A Undurraga; N Venketasubramanian; Lakshmi Vijayakumar; Theo Vos; Gregory R Wagner; Mengru Wang; Wenzhi Wang; Kerrianne Watt; Martin A Weinstock; Robert Weintraub; James D Wilkinson; Anthony D Woolf; Sarah Wulf; Pon-Hsiu Yeh; Paul Yip; Azadeh Zabetian; Zhi-Jie Zheng; Alan D Lopez; Christopher J L Murray; Mohammad A AlMazroa; Ziad A Memish
Journal:  Lancet       Date:  2012-12-15       Impact factor: 79.321

10.  Chronic hepatitis C virus (HCV) disease burden and cost in the United States.

Authors:  Homie Razavi; Antoine C Elkhoury; Elamin Elbasha; Chris Estes; Ken Pasini; Thierry Poynard; Ritesh Kumar
Journal:  Hepatology       Date:  2013-05-06       Impact factor: 17.425
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