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Pravin Jadhav

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TOP 3
Jiang Liu; Yaning Wang; Pravin R Jadhav; Jogarao V S Gobburu
Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval.
Jeffry Florian; Patrick Harrington; Pravin R Jadhav; Poonam Mishra; Jules O'Rear; Michael Pacanowski; Sarah Robertson; Mary Singer; Greg Soon; Wen Zeng; Shashi Amur; Ruben Ayala; Jeffrey Murray
Boceprevir dosing for late responders and null responders: the role of bridging data between treatment-naïve and -experienced subjects.
Jiang Liu; Lisa K Naeger; Jule O'Rear; Michael Pacanowski; Sarah Robertson; Shirley Seo; Greg Soon; Russell Fleischer; Thomas Hammerstrom; Pravin R Jadhav; Linda Lewis; Shashi Amur; Debra Birnkrant
Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects.

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All Publications

2013: Jiang Liu; Yaning Wang; Pravin R Jadhav; Jogarao V S Gobburu
Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval.
The AAPS journal 2013;15(2):407-14.
2013: Jeffry Florian; Patrick Harrington; Pravin R Jadhav; Poonam Mishra; Jules O'Rear; Michael Pacanowski; Sarah Robertson; Mary Singer; Greg Soon; Wen Zeng; Shashi Amur; Ruben Ayala; Jeffrey Murray
Boceprevir dosing for late responders and null responders: the role of bridging data between treatment-naïve and -experienced subjects.
Hepatology (Baltimore, Md.) 2013;57(3):903-7.
2013: Jiang Liu; Lisa K Naeger; Jule O'Rear; Michael Pacanowski; Sarah Robertson; Shirley Seo; Greg Soon; Russell Fleischer; Thomas Hammerstrom; Pravin R Jadhav; Linda Lewis; Shashi Amur; Debra Birnkrant
Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects.
Hepatology (Baltimore, Md.) 2013;57(3):897-902.
2012: Yaning Wang; Pravin R Jadhav; Mallika Lala; Jogarao V S Gobburu
Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies.
Journal of clinical pharmacology 2012;52(10):1601-6.
2012: Jiang Liu; Jeffrey Murray; Debra Birnkrant; Jeffry Florian; Pravin R Jadhav
Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: implications for drug development and clinical decisions.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2012;55(5):639-44.
2011: Kevin Krudys; Atul Bhattaram; Ying Chen; Jeffry Florian; Jogarao V S Gobburu; Pravin R Jadhav; Fang Li; Lauren Neal; Christoffer Tornoe; Yaning Wang; Peter I D Lee
Knowledge management for efficient quantitative analyses during regulatory reviews.
Expert review of clinical pharmacology 2011;4(6):697-703.
2011: Joo Yeon Lee; Lawrence J Lesko; Fang Li; Jiang Liu; Rajanikanth Madabushi; Anshu Marathe; Nitin Mehrotra; Christoffer Tornoe; Yaning Wang; Venkatesh Atul Bhattaram; Satjit Brar; Justin C Earp; Christine E Garnett; Jogarao V S Gobburu; Pravin R Jadhav; Kevin Krudys; Hao Zhu
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Clinical pharmacokinetics 2011;50(10):627-35.
2009: Pravin R Jadhav; Jialu Zhang; Jogarao V S Gobburu
Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.
Pharmaceutical statistics 2009;8(3):216-24.
2008: Yaning Wang; A Venkatesh Bhattaram; Pravin R Jadhav; Lawrence J Lesko; Rajanikanth Madabushi; J Robert Powell; Wei Qiu; He Sun; Dong S Yim; Jenny J Zheng; Jogarao V S Gobburu
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
Journal of clinical pharmacology 2008;48(2):146-56.
2008: Christine E Garnett; Nhi Beasley; Venkatesh Atul Bhattaram; Pravin R Jadhav; Rajanikanth Madabushi; Norman Stockbridge; Christoffer W Tornøe; Yaning Wang; Hao Zhu; Jogarao V S Gobburu
Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.
Journal of clinical pharmacology 2008;48(1):13-8.
2006: Pravin R Jadhav; Henrik Agersø; Christoffer W Tornøe; Jogarao V S Gobburu
Semi-mechanistic pharmacodynamic modeling for degarelix, a novel gonadotropin releasing hormone (GnRH) blocker.
Journal of pharmacokinetics and pharmacodynamics 2006;33(5):609-34.
2005: Pravin R Jadhav; Jogarao V S Gobburu
A new equivalence based metric for predictive check to qualify mixed-effects models.
The AAPS journal 2005;7(3):E523-31.