P. Jadhav

发表

Reporting guidelines for population pharmacokinetic analyses

C. Tornøe, N. Al-Huniti, K. Dykstra, 2015, Journal of Pharmacokinetics and Pharmacodynamics.

Evaluation of Model‐Based Prediction of Pharmacokinetics in the Renal Impairment Population

P. Zhao, K. Yee, Tamara D. Cabalu, 2018, Journal of clinical pharmacology.

Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects

S. Amur, Rubén Ayala, J. Murray, 2013, Hepatology.

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

S. Amur, Jiang Liu, L. Naeger, 2013, Hepatology.

From in vitro EC50 to in vivo dose–response for antiretrovirals using an HIV disease model. Part II: Application to drug development

P. Jadhav, Jing Fang, 2012, Journal of Pharmacokinetics and Pharmacodynamics.

Semi-Mechanistic Pharmacodynamic Modeling for Degarelix, a Novel Gonadotropin Releasing Hormone (GnRH) Blocker

J. Gobburu, C. Tornøe, P. Jadhav, 2006, Journal of Pharmacokinetics and Pharmacodynamics.

Harnessing the Potential of Emerging Digital Health and Biological Sampling Technologies for Clinical Drug Development: Promise to Reality

P. Kothare, P. Jadhav, L. Dickmann, 2018, Clinical pharmacology and therapeutics.

Pediatric Antihypertensive Trial Failures: Analysis of End Points and Dose Range

V. Hasselblad, R. Califf, P. Smith, 2008, Hypertension.

Reporting guidelines for population pharmacokinetic analyses

C. Tornøe, N. Al-Huniti, K. Dykstra, 2015, Journal of Pharmacokinetics and Pharmacodynamics.

Applications of Population Pharmacokinetics for Pediatric Drug Development

P. Jadhav, J. Momper, G. Burckart, 2013 .

Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval

Jiang Liu, J. Gobburu, P. Jadhav, 2013, The AAPS Journal.

Methodological Issues in the Design of Paediatric Pharmacokinetic Studies

D. Abernethy, Jian Wang, P. Jadhav, 2012, Pharmaceutical Medicine.

The Need for Modeling and Simulation to Design Clinical Investigations in Children

Steven Edward Kern, P. Jadhav, 2010, Journal of clinical pharmacology.

Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study

J. Gobburu, P. Jadhav, Jialu Zhang, 2009, Pharmaceutical statistics.

Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: implications for drug development and clinical decisions.

Jiang Liu, J. Murray, P. Jadhav, 2012, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies.

J. Murray, Jianmeng Chen, P. Jadhav, 2013, Gastroenterology.

Clarification on Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetic Studies

J. Gobburu, Mallika Lala, P. Jadhav, 2012, Journal of clinical pharmacology.

Innovation at the Intersection of Clinical Trials and Real‐World Data Science to Advance Patient Care

Dyfrig A. Hughes, Vasu Chandrasekaran, D. Hughes, 2018, Clinical and translational science.

Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004–2006

Yaning Wang, Lawrence J Lesko, Rajanikanth Madabushi, 2008, Journal of clinical pharmacology.

Concentration‐QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Norman Stockbridge, Yaning Wang, Christine E Garnett, 2008, Journal of clinical pharmacology.

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

Yaning Wang, Justin C. Earp, Christoffer Tornoe, 2011, Clinical pharmacokinetics.

A proposal for scientific framework enabling specific population drug dosing recommendations

N. Stockbridge, P. Zhao, J. Powell, 2015, Journal of clinical pharmacology.

Reporting guidelines for population pharmacokinetic analyses

C. Tornøe, N. Al-Huniti, K. Dykstra, 2015, Journal of Pharmacokinetics and Pharmacodynamics.

A new equivalence based metric for predictive check to qualify mixed-effects models

Jogarao V. S. Gobburu, J. Gobburu, P. Jadhav, 2005, The AAPS Journal.

Antiviral Information Management System (AIMS): A Prototype for Operational Innovation in Drug Development

L. Naeger, Guoxing Soon, P. Jadhav, 2010, Journal of clinical pharmacology.

From in vitro EC50 to in vivo dose–response for antiretrovirals using an HIV disease model. Part II: Application to drug development

P. Jadhav, Jing Fang, 2012, Journal of Pharmacokinetics and Pharmacodynamics.

From in vitro EC50 to in vivo dose–response for antiretrovirals using an HIV disease model. Part I: A framework

P. Jadhav, Jing Fang, 2012, Journal of Pharmacokinetics and Pharmacodynamics.

Why did the FDA approve efavirenz 800 mg when co-administered with rifampin?

Jiang Liu, Jeffrey B. Kraft, K. Chan-Tack, 2014, International journal of clinical pharmacology and therapeutics.

Knowledge management for efficient quantitative analyses during regulatory reviews

Yaning Wang, Christoffer Tornoe, Lauren Neal, 2011, Expert review of clinical pharmacology.

Utility of Model‐Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

B. Corrigan, N. Stockbridge, P. Zhao, 2016, Journal of clinical pharmacology.

Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval

Jiang Liu, J. Gobburu, P. Jadhav, 2013, The AAPS Journal.