Pravin Jadhav

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All published works

Action	Title	Year	Authors
+	A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk	2024	Chenna Keshava Reddy Sannala Carol M. MacLean Finn Ole Larsen Steve van Os Pravin Jadhav Neal D. Shore Alicia K. Morgans Tochukwu Okwuosa Jogarao Gobburu
+ PDF Chat	Innovation at the Intersection of Clinical Trials and Real‐World Data Science to Advance Patient Care	2018	Brandon Swift Lokesh Jain Craig White Vasu Chandrasekaran Aman Bhandari Dyfrig Hughes Pravin Jadhav
+	Evaluation of Model‐Based Prediction of Pharmacokinetics in the Renal Impairment Population	2017	Ka Lai Yee Mengyao Li Tamara D. Cabalu Vaishali Sahasrabudhe Jian Lin Ping Zhao Pravin Jadhav
+	Utility of Model‐Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop	2016	Islam R. Younis J. Robert Powell Amin Rostami‐Hodjegan Brian Corrigan Norman Stockbridge Vikram Sinha Ping Zhao Pravin Jadhav Bruno Flamion Jack Cook
+ PDF Chat	Reporting guidelines for population pharmacokinetic analyses	2015	Kevin Dykstra Nitin Mehrotra Christoffer W. Tornøe Helen Kastrissios Bela Patel Nidal Al‐Huniti Pravin Jadhav Yaning Wang Wonkyung Byon
+ PDF Chat	A proposal for scientific framework enabling specific population drug dosing recommendations	2015	Pravin Jadhav Jack Cook Vikram Sinha Ping Zhao Amin Rostami‐Hodjegan Vaishali Sahasrabudhe Norman Stockbridge J. Robert Powell
+ PDF Chat	Reporting guidelines for population pharmacokinetic analyses	2015	Kevin Dykstra Nitin Mehrotra Christoffer W. Tornøe Helen Kastrissios Bela Patel Nidal Al‐Huniti Pravin Jadhav Yaning Wang Wonkyung Byon
+	Implications of choosing a correlation structure on model selection and parameter estimation	2014	Lokesh Jain Pravin Jadhav Jogarao Gobburu
+	Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval	2013	Jiang Liu Pravin Jadhav Yaning Wang Jogarao Gobburu
+	Methodological Issues in the Design of Paediatric Pharmacokinetic Studies	2012	Gilbert J. Burckart Kristina E. Estes Rupert W. Leong Yeruk Mulugeta Veneeta Tandon Jian Wang Darrell R. Abernethy Pravin Jadhav
+	Knowledge management for efficient quantitative analyses during regulatory reviews	2011	Kevin Krudys Fang Li Jeffry Florian Christoffer W. Tornøe Ying Chen Atul Bhattaram Pravin Jadhav Lauren Neal Yaning Wang Jogarao Gobburu
+	Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions	2011	Joo Yeon Lee Christine Garnett Jogarao Gobburu Venkatesh Atul Bhattaram Satjit Brar Justin Earp Pravin Jadhav Kevin Krudys Lawrence J. Lesko Fang Li
+	The Need for Modeling and Simulation to Design Clinical Investigations in Children	2010	Pravin Jadhav Steven E. Kern
+	Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004–2006	2008	Yaning Wang Atul Bhattaram Pravin Jadhav Lawrence J. Lesko Rajanikanth Madabushi J. Robert Powell Wei Qiu He Sun Dong‐Seok Yim Jenny Jingwen Zheng
+	A new equivalence based metric for predictive check to qualify mixed-effects models	2005	Pravin Jadhav Jogarao Gobburu

Common Coauthors

Coauthor	Papers Together
Jogarao Gobburu	7
Yaning Wang	5
Christoffer W. Tornøe	4
Nitin Mehrotra	3
Ping Zhao	3
Helen Kastrissios	2
Vaishali Sahasrabudhe	2
Jack Cook	2
Kevin Dykstra	2
Vikram Sinha	2
Kevin Krudys	2
Wonkyung Byon	2
Bela Patel	2
Amin Rostami‐Hodjegan	2
J. Robert Powell	2
Norman Stockbridge	2
Lawrence J. Lesko	2
Nidal Al‐Huniti	2
Lokesh Jain	2
Atul Bhattaram	2
Vasu Chandrasekaran	1
Islam R. Younis	1
Kristina E. Estes	1
Steve van Os	1
Veneeta Tandon	1
Jian Lin	1
Gilbert J. Burckart	1
Craig White	1
Yeruk Mulugeta	1
Carol M. MacLean	1
Ka Lai Yee	1
Neal D. Shore	1
Venkatesh Atul Bhattaram	1
Chenna Keshava Reddy Sannala	1
Jiang Liu	1
Jian Wang	1
Mengyao Li	1
Fang Li	1
Yaning Wang	1
He Sun	1
Hao Zhu	1
Finn Ole Larsen	1
J. Robert Powell	1
Jiang Liu	1
Jeffry Florian	1
Jenny Jingwen Zheng	1
Tochukwu Okwuosa	1
Satjit Brar	1
Rajnikanth Madabushi	1
Darrell R. Abernethy	1

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+	Evaluation of methods for estimating population pharmacokinetic parameters. I. Michaelis-menten model: Routine clinical pharmacokinetic data	1980	Lewis B. Sheiner Stuart L. Beal	2
+	Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004–2006	2008	Yaning Wang Atul Bhattaram Pravin Jadhav Lawrence J. Lesko Rajanikanth Madabushi J. Robert Powell Wei Qiu He Sun Dong‐Seok Yim Jenny Jingwen Zheng	2
+	Quantitative Disease, Drug, and Trial Models	2008	Jogarao Gobburu Lawrence J. Lesko	2
+ PDF Chat	A proposal for scientific framework enabling specific population drug dosing recommendations	2015	Pravin Jadhav Jack Cook Vikram Sinha Ping Zhao Amin Rostami‐Hodjegan Vaishali Sahasrabudhe Norman Stockbridge J. Robert Powell	2
+	Ways to fit a PK model with some data below the quantification limit.	2001	Stuart L. Beal	2
+	Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications	2005	Venkatesh Atul Bhattaram Brian Booth Roshni Ramchandani B. Nhi Beasley Yaning Wang Veneeta Tandon John Duan Raman Baweja Patrick Marroum Ramana Uppoor	2
+ PDF Chat	Reporting a Population Pharmacokinetic–Pharmacodynamic Study: A Journal’s Perspective	2013	Kris M. Jamsen Sarah McLeay Michael Barras Bruce Green	2
+	A guide for reporting the results of population pharmacokinetic analyses: A Swedish perspective	2005	Janet R. Wade Monica Edholm Tomas Salmonson	2
+	Pharmacometrics as a Discipline Is Entering the “Industrialization” Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success	2010	Klaus Romero Brian Corrigan Christoffer W. Tornøe Jogarao Gobburu Meindert Danhof William R. Gillespie Marc R. Gastonguay Bernd Meibohm Hartmut Derendorf	2
+	Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry Perspective	2012	Peter L. Bonate Ashley Strougo Amit Desai Michael J. Roy Ashraf Yassen J. S. Van der Walt Atsunori Kaibara Stacey Tannenbaum	2
+ PDF Chat	Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance	2013	Wonkyung Byon Michael K. Smith P Chan MA Tortorici Steve Riley Haiqing Dai Jing Dong Ana Ruíz‐García Kevin Sweeney Carol Cronenberger	2
+	Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions	2011	Joo Yeon Lee Christine Garnett Jogarao Gobburu Venkatesh Atul Bhattaram Satjit Brar Justin Earp Pravin Jadhav Kevin Krudys Lawrence J. Lesko Fang Li	2
+	Handling Data Below the Limit of Quantification in Mixed Effect Models	2009	Martin Bergstrand Mats O. Karlsson	1
+	The Need for Modeling and Simulation to Design Clinical Investigations in Children	2010	Pravin Jadhav Steven E. Kern	1
+ PDF Chat	Considerations for Clinical Trial Design and Data Analyses of Thorough QT Studies Using Drug‐Drug Interaction	2010	Hao Zhu Yaning Wang Jogarao Gobburu Christine Garnett	1
+	Robustness of maximum likelihood estimates for multi-step predictions: The exponential smoothing case	1993	George C. Tiao Daming Xu	1
+	Economic Evaluations During Early (Phase II) Drug Development	2001	Dyfrig Hughes Tom Walley	1
+	Utilisation of Pharmacokinetic- Pharmacodynamic Modelling and Simulation in Regulatory Decision-Making	2001	Jogarao Gobburu Patrick Marroum	1
+	Impact of Population Pharmacokinetic- Pharmacodynamic Analyses on the Drug Development Process	2000	Stephen C. Olson Howard N. Bockbrader Rebecca A. Boyd Jack Cook Jeffrey R. Koup Richard L. Lalonde Paul H. Siedlik J. Robert Powell	1
+	Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review	2010	Ping Zhao L Zhang Joseph A. Grillo Q. Liu Julie Bullock Young‐Jin Moon Pengfei Song Satjit Brar Rajanikanth Madabushi Ta C. Wu	1
+	Pharmacometrics at FDA: Evolution and Impact on Decisions	2007	J. Robert Powell Jogarao Gobburu	1
+ PDF Chat	Patient adherence: Clinical pharmacology's embarrassing relative	2014	Michael J. Fossler	1
+	Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?	2007	Lawrence J. Lesko	1
+	Population pharmacokinetic studies in pediatrics: Issues in design and analysis	2005	Bernd Meibohm Stephanie Läer John C. Panetta Jeffrey S. Barrett	1
+	A Pharmacometric Model Describing the Relationship Between Warfarin Dose and INR Response With Respect to Variations in CYP2C9, VKORC1, and Age	2010	Anna‐Karin Hamberg Mia Wadelius Jonatan D. Lindh M L Dahl Roberto Padrini Panos Deloukas Anders Rane E. Niclas Jonsson	1
+	Improving Productivity With Model-Based Drug Development: An Enterprise Perspective	2010	Thaddeus H. Grasela Robert Slusser	1
+ PDF Chat	Proposals for model‐based paediatric medicinal development within the current European Union regulatory framework	2009	Efthymios Manolis Gérard Pons	1
+	Development and implementation of the population Fisher information matrix for the evaluation of population pharmacokinetic designs	2001	Sylvie Retout Stephen B. Duffull France Mentré	1
+	Understanding the Relative Roles of Pharmacogenetics and Ontogeny in Pediatric Drug Development and Regulatory Science	2010	J. Steven Leeder Gregory L. Kearns Stephen P. Spielberg John van den Anker	1
+ PDF Chat	Physiologically based and population PK modeling in optimizing drug development: A predict–learn–confirm analysis	2015	Ajit Suri Sunny Chapel C. Lu Karthik Venkatakrishnan	1
+	MEDICATION COMPLIANCE AS A FEATURE IN DRUG DEVELOPMENT	1997	Hill and Terrence F. Blaschke	1
+ PDF Chat	Diagnostic Checks for Discrete Data Regression Models Using Posterior Predictive Simulations	2000	Andrew Gelman Yuri Goegebeur Francis Tuerlinckx Iven Van Mechelen	1
+	Methods for Measuring, Enhancing, and Accounting for Medication Adherence in Clinical Trials	2014	Bernard Vrijens John Urquhart	1
+	Complexities in drug trials: enrichment, biomarkers and surrogates	2008	Robert Temple	1
+	Pharmacokinetic/Pharmacodynamic Modeling in Drug Development	2000	Lewis B. Sheiner Jean‐Louis Steimer	1
+ PDF Chat	How Modeling and Simulation Have Enhanced Decision Making in New Drug Development	2005	Raymond Miller Wayne Ewy Brian Corrigan Danièle Ouellet David Hermann Kenneth G. Kowalski Peter Lockwood Jeffrey R. Koup Sean D. Donevan Ayman El‐Kattan	1
+	POSTERIOR PREDICTIVE ASSESSMENT OF MODEL FITNESS VIA REALIZED DISCREPANCIES	1996	Andrew Gelman Xiao‐Li Meng Hal S. Stern	1
+	Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check.	2001	Yoshitaka Yano Stuart L. Beal Lewis B. Sheiner	1
+	Designing and incorporating a real world data approach to international drug development and use: what the UK offers	2015	Andrew Bate Jane Juniper Andy Lawton Rob Thwaites	1
+	Implications of choosing a correlation structure on model selection and parameter estimation	2014	Lokesh Jain Pravin Jadhav Jogarao Gobburu	1
+ PDF Chat	Interdisciplinary pharmacometrics linking oseltamivir pharmacology, influenza epidemiology and health economics to inform antiviral use in pandemics	2017	Mohamed Kamal Patrick F. Smith Nathorn Chaiyakunapruk David Bin‐Chia Wu Chayanin Pratoomsoot Kenneth K.C. Lee Huey Yi Chong Richard E. Nelson Keith Nieforth Georgina Dall	1
+ PDF Chat	Deep EHR: A Survey of Recent Advances in Deep Learning Techniques for Electronic Health Record (EHR) Analysis	2017	Benjamin Shickel Patrick J. Tighe Azra Bihorac Parisa Rashidi	1
+	Implementing Clinical Prediction Models: Pushing the Needle Towards Precision Pharmacotherapy	2017	Sreemanee Raaj Dorajoo Alexandre Chan	1
+ PDF Chat	Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality	2017	Rebecca A. Miksad Amy P. Abernethy	1
+	How Well Are We Applying Quantitative Methods to Reverse Translation to Inform Early Clinical Development?	2017	Anne C. Heatherington Sreeneeranj Kasichayanula Karthik Venkatakrishnan	1
+	Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations	2019	Yaning Wang Hao Zhu Rajanikanth Madabushi Qi Liu Shiew‐Mei Huang Issam Zineh	1
+ PDF Chat	“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?	2016	H‐G Eichler Brigitte Bloechl‐Daum Philipp K. Bauer Frank Bretz Jeffrey S. Brown L Hampson Peter K. Honig Michael Krams Hubert G.M. Leufkens Robyn Lim	1
+	Assessment of actual significance levels for covariate effects in NONMEM.	2001	Ulrika Wählby E. Niclas Jonsson Mats O. Karlsson	1
+ PDF Chat	Valuing Trial Designs from a Pharmaceutical Perspective Using Value-Based Pricing	2014	Penny Breeze Alan Brennan	1
+ PDF Chat	Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting<scp>PBPK</scp>models to observed clinical data	2013	Nikolaos Tsamandouras Amin Rostami‐Hodjegan Leon Aarons	1