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  1. Center for Drug Evaluation and Research (CDER)

Pharmacometrics at FDA - Publications

2017               

  • Li L, Zhang Y, Ma L, Ji P, Yim S, Chowdhury BA, Doddapaneni S, Liu J, Wang Y, Sahajwalla C, Exposure-Response Modeling and Power Analysis of Components of ACR Response Criteria in Rheumatoid Arthritis (Part 2: Continuous Model). J Clin Pharmacol.  2017 https://www.ncbi.nlm.nih.gov/pubmed/28817201
  • Li L, Zhang Y, Ma L, Ji P, Yim S, Chowdhury B, Doddapaneni S, Liu J, Wang Y, Sahajwalla C, Exposure-Response Modeling and Power Analysis of Components of ACR Response Criteria in Rheumatoid Arthritis (Part 1: Binary Model). J Clin Pharmacol.  2017 https://www.ncbi.nlm.nih.gov/pubmed/28817199
  • Li H, Yu J, Liu C, Liu J, Subramaniam S, Zhao H, Blumenthal GM, Turner DC, Li C, Ahamadi M, de Greef R, Chatterjee M, Kondic AG, Stone JA, Booth BP, Keegan P, Rahman A, Wang Y, Time Dependent Pharmacokinetics of Pembrolizumab in Patients with Solid Tumor and Its Correlation with Best Overall Response. J Pharmacokinet Pharmacodyn. 2017 https://www.ncbi.nlm.nih.gov/pubmed/28573468
  • Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA, Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017  https://www.ncbi.nlm.nih.gov/pubmed/28388260
  • Li L, Wang Y, Uppoor RS, Mehta MU, Farchione T, Mathis MV, Zhu H, Exposure-Response Analyses of Blood Pressure and Heart Rate Changes for Methylphenidate in Healthy Adults. J Pharmacokinet Pharmacodyn. 2017 https://www.ncbi.nlm.nih.gov/pubmed/28214989
  • Liu C, Yu J, Li H, Liu J, Xu Y, Song P, Liu Q, Zhao H, Xu J, Maher VE, Booth BP, Kim G, Rahman A, Wang Y, Association of Time-Varying Clearance of Nivolumab with Disease Dynamics and its Implications on Exposure-Response Analysis. Clin Pharmacol Ther. 2017  https://www.ncbi.nlm.nih.gov/pubmed/28182273
  • Mishra P, Florian J, Peter J, Vainorius M, Fried MW, Nelson DR, Birnkrant D, Public-Private Partnership: Targeting Real-World Data for Hepatitis C Direct-Acting Antivirals. Gastroenterology. 2017 https://www.ncbi.nlm.nih.gov/pubmed/28757271
  • Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Röhss K, Sandström M, Taylor A, Tornøe CW, Wynn EL, Van der Walt JS, Garnett C. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response. J Pediatr Gastroenterol Nutr. 2017 https://www.ncbi.nlm.nih.gov/pubmed/27875488
  • Younis IR, Robert Powell J, Rostami-Hodjegan A, Corrigan B, Stockbridge N, Sinha V, Zhao P, Jadhav P, Flamion B, Cook J. Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report from the Public AAPS Workshop. J Clin Pharmacol. 2017 https://www.ncbi.nlm.nih.gov/pubmed/27365151

2016               

  • Yu J, Chung S, Zadezensky I, Hu K, Darstein C, Nedelman J, Mehrotra N, Utility of Exposure-Response Analysis in Regulatory Decision on the Selection of Starting Dose of Pasireotide for Cushing Disease. J Clin Pharmacol. 2016  https://www.ncbi.nlm.nih.gov/pubmed/26686944
  • Wang J, Mehrotra N, Kim I, Lee SC, Sohrabi F, He R, Mulberg A, Sinha V, Ahn HY, Bashaw D, Griebel D, Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2016 https://www.ncbi.nlm.nih.gov/pubmed/26913757
  • Mulugeta Y, Barrett JS, Nelson R, Eshete AT, Mushtaq A, Yao L, Glasgow N, Mulberg AE, Gonzalez D, Green D, Florian J, Krudys K, Seo S, Kim I, Chilukuri D, Burckart GJ, Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.   J Clin Pharmacol. 2016 https://www.ncbi.nlm.nih.gov/pubmed/27040726
  • Mehrotra N, Bhattaram A, Earp JC, Florian J, Krudys K, Lee JE, Lee JY, Liu J, Mulugeta Y, Yu J, Zhao P, Sinha V, Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling. Drug Metab Dispos. 2016  https://www.ncbi.nlm.nih.gov/pubmed/27079249
  • Sy SK, Zhuang L, Derendorf H. Pharmacokinetics and Pharmacodynamics in Antibiotic Dose Optimization. Expert Opin Drug Metab Toxicol. 2016 https://www.ncbi.nlm.nih.gov/pubmed/26652832
  • Li CH, Bies RR, Wang Y, Sharma MR, Karovic S, Werk L, Edelman MJ, Miller AA, Vokes EE, Oto A, Ratain MJ, Schwartz LH, Maitland ML. Comparative Effects of CT Imaging Measurement on RECIST End Points and Tumor Growth Kinetics Modeling.  Clin Transl Sci. 2016 https://www.ncbi.nlm.nih.gov/pubmed/26790562
  • Zhuang L, He Y, Xia H, Liu Y, Sy SK, Derendorf H. Gentamicin Dosing Strategy in Patients with End-Stage Renal Disease Receiving Haemodialysis: Evaluation Using a Semi-Mechanistic Pharmacokinetic/Pharmacodynamic Model. J Antimicrob Chemother. 2016 https://www.ncbi.nlm.nih.gov/pubmed/26702923
  • Garnett C, Needleman K, Liu J, Brundage R, Wang Y. Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies. Clin Pharmacol Ther. 2016 https://www.ncbi.nlm.nih.gov/pubmed/26946218

2015                           

  • Dykstra K, Mehrotra N, Tornøe CW, Kastrissios H, Patel B, Al-Huniti N, Jadhav P, Wang Y, Byon W, Reporting Guidelines for Population Pharmacokinetic Analyses. J Clin Pharmacol. 2015 https://www.ncbi.nlm.nih.gov/pubmed/26148467
  • Zhou D, Li H, Wang Y, Hochhaus G, Sinha V, Zhao L, Quantitative Characterization of Circadian Rhythm of Pulmonary Function in Asthmatic Patients Treated with Inhaled Corticosteroids. J Pharmacokinet Pharmacodyn. 2015 https://www.ncbi.nlm.nih.gov/pubmed/26099861
  • Jadhav PR, Cook J, Sinha V, Zhao P, Rostami-Hodjegan A, Sahasrabudhe V, Stockbridge N, Powell JR. A Proposal for Scientific Framework Enabling Specific Population Drug Dosing Recommendations. J Clin Pharmacol 2015 https://www.ncbi.nlm.nih.gov/pubmed/26109076
  • Stephenson D, Hu MT, Romero K, Breen K, Burn D, Ben-Shlomo Y, Bhattaram A, Isaac M, Venuto C, Kubota K, Little MA, Friend S, Lovestone S, Morris HR, Grosset D, Sutherland M, Gallacher J, Williams-Gray C, Bain LJ, Aviles E, Marek K, Toga AW, Stark Y, Forrest Gordon M, Ford S. Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease. J Parkinsons Dis 2015 http://www.maxlittle.net/publications/stephenson_jpd_2015.pdf
  • Khurana M, Vaidyanathan J, Marathe A, Mehrotra N, Sahajwalla CG, Zineh I, Jain L. Canagliflozin Use in Patients with Renal Impairment--Utility of Quantitative Clinical Pharmacology Analyses in Dose Optimization. J Clin Pharmacol 2015 https://www.ncbi.nlm.nih.gov/pubmed/25612234
  • Wang Y, Harigaya Y, Cavaille-Coll M, Colangelo P, Reynolds KS. Justification of Non-Inferiority Margin: Methodology Considerations in an Exposure Response Analysis. Clin Pharmacol Ther 2015 https://www.ncbi.nlm.nih.gov/pubmed/25670256
  • Romero K, Ito K, Rogers JA, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, Brown D, Isaac M, Vamvakas S, Hemmings R, Pani L, Bain LJ, Corrigan B, Alzheimer’s Disease Neuroimaging Initiative for the Coalition Against Major Diseases. The Future is Now: Model-Based Clinical Trial Design for Alzheimer's Disease. Clin Pharmacol Ther 2015 https://www.ncbi.nlm.nih.gov/pubmed/25669145
  • Venkatakrishnan K, Friberg L, Ouellet D, Mettetal J, Stein A, Troconiz I, Bruno R, Mehrotra N, Gobburu J, Mould D. Optimizing Oncology Therapeutics Through Quantitative Translational and Clinical Pharmacology: Challenges and Opportunities. Clin Pharmacol Ther 2015 https://www.ncbi.nlm.nih.gov/pubmed/25670382
  • Jadhav PR, Cook J, Sinha V, Zhao P, Rostami-Hodjegan A, Sahasrabudhe V, Stockbridge N, Powell JR. A Proposal for Scientific Framework Enabling Specific Population Drug Dosing Recommendations. J Clin Pharmacol 2015 https://www.ncbi.nlm.nih.gov/pubmed/26109076
  • Florian J, Mishra P, Arya V, Harrington P, Connelly S, Reynold KS, Sinha V. Direct-Acting Antiviral Drugs for the Treatment of Chronic Hepatitis C Virus Infection: Interferon Free is Now. Clin Pharmacol Ther 2015 https://www.ncbi.nlm.nih.gov/pubmed/26179495
  • Lon HK, DuBois DC, Earp JC, Almon RR, Jusko WJ. Modeling Effects of Dexamethasone on Disease Progression of Bone Mineral Density in Collagen-Induced Arthritic Rats. Pharmacol Res Perspect 2015 https://www.ncbi.nlm.nih.gov/pubmed/26516581
  • Stephenson D, Hu MT, Romero K, Breen K, Burn D, Ben-Shlomo Y, Bhattaram A, Isaac M, Venuto C, Kubota K, Little MA, Friend S, Lovestone S, Morris HR, Grosset D, Sutherland M, Gallacher J, Williams-Gray C, Bain LJ, Aviles E, Marek K, Toga AW, Stark Y, Forrest Gordon M, Ford S. Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease. J Parkinsons Dis 2015
    https://www.ncbi.nlm.nih.gov/pubmed/26406139

2014                           

  • Jin Y, Bies R, Gastonguay MR, Wang Y, Stockbridge N, Gobburu J, Madabushi R, Predicted Impact of Various Clinical Practice Strategies on Cardiovascular Risk for the Treatment of Hypertension: a Clinical Trial Simulation Study. J Pharmacokinet Pharmacodyn. 2014 https://www.ncbi.nlm.nih.gov/pubmed/25326066
  • Romero K, Sinha V, Allerheiligen S, Danhof M, Pinheiro J, Kruhlak N, Wang Y, Wang SJ, Sauer JM, Marier JF, Corrigan B, Rogers J, Lambers Heerspink HJ, Gumbo T, Vis P, Watkins P, Morrison T, Gillespie W, Gordon MF, Stephenson D, Hanna D, Pfister M, et al, Modeling and Simulation for Medical Product Development and Evaluation: Highlights from the FDA-C-Path-ISOP 2013 Workshop. J Pharmacokinet Pharmacodyn. 2014 https://www.ncbi.nlm.nih.gov/pubmed/25288257
  • Ma L, Zhao L, Xu Y, Yim S, Doddapaneni S, Sahajwalla CG, Wang Y, Ji P, Clinical Endpoint Sensitivity in Rheumatoid Arthritis: Modeling and Simulation. J Pharmacokinet Pharmacodyn. 2014 https://www.ncbi.nlm.nih.gov/pubmed/25283268
  • Bruno R, Mentre F, Tannenbaum S, Wang Y, Corrigan B, Mager DE, The ISoP Standards and Best Practices Committee. Clin Pharmacol Ther. 2014 https://www.ncbi.nlm.nih.gov/pubmed/24842638
  • Mishra P, Florian J, Murray J, FDA Bridging Analyses Confirmed in Clinical Trial. Hepatology. 2014 https://www.ncbi.nlm.nih.gov/pubmed/24591059
  • Liu J, Chan-Tack KM, Jadhav P, Seo S, Robertson SM, Kraft J, Singer ME, Struble KA, Arya V, Why Did the FDA Approve Efavirenz 800 mg When Co-Administered with Rifampin? Int J Clin Pharmacol Ther. 2014 https://www.ncbi.nlm.nih.gov/pubmed/24755134

2013                     

  • Huang SM, Abernethy DR, Wang Y, Zhao P, Zineh I, The Utility of Modeling and Simulation in Drug Development and Regulatory Review. J Pharm Sci. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23712632
  • Sun W, Laughren TP, Zhu H, Hochhaus G, Wang Y, Development of a Placebo Effect Model Combined with a Dropout Model for Bipolar Disorder. J Pharmacokinet Pharmacodyn. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23456101
  • Yang J, Zhao H, Garnett C, Rahman A, Gobburu JV, Pierce W, Schechter G, Summers J, Keegan P, Booth B, Wang Y, The Combination of Exposure-Response and Case-Control Analyses in Regulatory Decision Making. J Clin Pharmacol. 2013  https://www.ncbi.nlm.nih.gov/pubmed/23436261
  • Younis IR, Laughren TP, Wang Y, Mathis M, Gobburu JV, An Integrated Approach for Establishing Dosing Recommendations: Paliperidone for the Treatment of Adolescent Schizophrenia. J Clin Psychopharmacol. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23422374
  • William-Faltaos D, Chen Y, Wang Y, Gobburu J, Zhu H, Quantification of Disease Progression and Dropout for Alzheimer's Disease. Int J Clin Pharmacol Ther. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23211395
  • Fourie Zirkelbach J, Jackson AJ, Wang Y, Schuirmann DJ. Use of Partial AUC (PAUC) to Evaluate Bioequivalence--a Case Study with Complex Absorption: Methylphenidate. Pharm Res. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23007665
  • Lee JY, Wang Y, Use of a Biomarker in Exposure-Response Analysis to Support Dose Selection for Fingolimod. CPT Pharmacometrics Syst Pharmacol. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23965783
  • Chen J, Florian J, Carter W, Fleischer RD, Hammerstrom TS, Jadhav PR, Zeng W, Murray J, Birnkrant D, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies. Gastroenterology. 2013 https://www.ncbi.nlm.nih.gov/pubmed/23470616
  • Florian J, Jadhav PR, Amur S, Ayala R, Harrington P, Mishra P, O'Rear J, Pacanowski M, Robertson S, Singer M, Soon G, Zeng W, Murray J.      Boceprevir Dosing for Late Responders and Null Responders: the Role of Bridging Data Between Treatment-Naïve and -Experienced subjects. Hepatology. 2013 https://www.ncbi.nlm.nih.gov/pubmed/22610696

 

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