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Yaning Wang

Research Profile

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United States Food and Drug Administration

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United States

Chemicals & Drugs

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Publications

TOP 3
Wan Sun; Guenther Hochhaus; Thomas P Laughren; Hao Zhu; Yaning Wang
Development of a placebo effect model combined with a dropout model for bipolar disorder.
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.
Jun Yang; Hong Zhao; Brian Booth; Christine Garnett; Jogarao V S Gobburu; Patricia Keegan; William Pierce; Atiqur Rahman; Genevieve Schechter; Jeffery Summers; Yaning Wang
The combination of exposure-response and case-control analyses in regulatory decision making.

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All Publications

2013: Wan Sun; Guenther Hochhaus; Thomas P Laughren; Hao Zhu; Yaning Wang
Development of a placebo effect model combined with a dropout model for bipolar disorder.
Journal of pharmacokinetics and pharmacodynamics 2013;40(3):359-68.
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: Jun Yang; Hong Zhao; Brian Booth; Christine Garnett; Jogarao V S Gobburu; Patricia Keegan; William Pierce; Atiqur Rahman; Genevieve Schechter; Jeffery Summers; Yaning Wang
The combination of exposure-response and case-control analyses in regulatory decision making.
Journal of clinical pharmacology 2013;53(2):160-6.
2013: Shiew-Mei Huang; N Mehrotra; A Bhattaram; Yaning Wang
Is this the dose for you?: the role of modeling.
Clinical pharmacology and therapeutics 2013;93(2):159-62.
2013: Jeanne Fourie Zirkelbach; Andre J Jackson; Yaning Wang; Donald J Schuirmann
Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.
Pharmaceutical research 2013;30(1):191-202.
2012: Ping Ji; Zhihong Li; Suresh Doddapaneni; Scott Furness; Sharon Hertz; Yaning Wang; Chandrahas G Sahajwalla
Regulatory review of acetaminophen clinical pharmacology in young pediatric patients.
Journal of pharmaceutical sciences 2012;101(12):4383-9.
2012: Ethan M Stier; Ramana S Uppoor; Yaning Wang; Lawrence Yu; Barbara M Davit; Jeanne Fourie-Zirkelbach; Andre Jackson; Stephanie Kim; Robert Lionberger; Mehul Mehta; Parthapratim Chandaroy; Mei-Ling Chen; Dale P Conner
Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.
The AAPS journal 2012;14(4):925-6.
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.
2011: Hao Zhu; Yaning Wang
Evaluation of false positive rate based on exposure-response analyses for two compounds in fixed-dose combination products.
Journal of pharmacokinetics and pharmacodynamics 2011;38(6):671-96.
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.
2011: Thomas Laughren; Jee Eun Lee; Robert L Levin; Cheri Y Lindberg; Mitchell Mathis; Barry N Rosloff; Robert J Temple; Ellis F Unger; Sue-Jane Wang; Yaning Wang; Peiling Yang; Bei Yu; Huixia Zhang; Li Zhang; Atul Bhattaram; Phillip V Dinh; Linda Fossom; Jogarao V S Gobburu; H M James Hung; Violetta Klimek; Issam Zineh
Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.
The Journal of clinical psychiatry 2011;72(9):1166-73.
2011: Christoffer W Tornøe; Yaning Wang; Jeffry Florian; Christine E Garnett; Michael Li; Jogarao V S Gobburu
Creation of a knowledge management system for QT analyses.
Journal of clinical pharmacology 2011;51(7):1035-42.
2010: Mei-Ling Chen; Vinod P Shah; Derek Ganes; Kamal K Midha; James Caro; Prabu Nambiar; Mario L Rocci; Avinash G Thombre; Bertil Abrahamsson; Dale Conner; Barbara Davit; Paul Fackler; Colm Farrell; Suneel Gupta; Russell Katz; Mehul Mehta; Sheldon H Preskorn; Gerard Sanderink; Salomon Stavchansky; Robert Temple; Yaning Wang; Helen Winkle; Lawrence Yu
Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.
Clinical therapeutics 2010;32(10):1704-12.
2010: Mei-Ling Chen; Vinod P Shah; Derek Ganes; Kamal K Midha; James Caro; Prabu Nambiar; Mario L Rocci; Avinash G Thombre; Bertil Abrahamsson; Dale Conner; Barbara Davit; Paul Fackler; Colm Farrell; Suneel Gupta; Russell Katz; Mehul Mehta; Sheldon H Preskorn; Gerard Sanderink; Salomon Stavchansky; Robert Temple; Yaning Wang; Helen Winkle; Lawrence Yu
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
The AAPS journal 2010;12(3):371-7.
2010: Mei-Ling Chen; Vinod P Shah; Derek Ganes; Kamal K Midha; James Caro; Prabu Nambiar; Mario L Rocci; Avinash G Thombre; Bertil Abrahamsson; Dale Conner; Barbara Davit; Paul Fackler; Colm Farrell; Suneel Gupta; Russell Katz; Mehul Mehta; Sheldon H Preskorn; Gerard Sanderink; Salomon Stavchansky; Robert Temple; Yaning Wang; Helen Winkle; Lawrence Yu
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences 2010;40(2):148-53.
2010: Yaning Wang; Christine Garnett
Response to letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by Yi Tsong et al.
Journal of biopharmaceutical statistics 2010;20(3):689-92; author reply 693-7.
2009: Yaning Wang; C Sung; C Dartois; Roshni P Ramchandani; Brian P Booth; E Rock; Jogarao V S Gobburu
Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development.
Clinical pharmacology and therapeutics 2009;86(2):167-74.
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.
2007: Venkatesh Atul Bhattaram; C Bonapace; D M Chilukuri; John Z Duan; C Garnett; Jogarao V S Gobburu; S H Jang; L Kenna; Lawrence J Lesko; Rajanikanth Madabushi; Y Men; J Robert Powell; W Qiu; Roshni P Ramchandani; C W Tornoe; Yaning Wang; J J Zheng
Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.
Clinical pharmacology and therapeutics 2007;81(2):213-21.
2007: Roshni P Ramchandani; Yaning Wang; Brian P Booth; Amna Ibrahim; John R Johnson; Atiqur Rahman; Mehul Mehta; Federico Innocenti; Mark J Ratain; Jogarao V S Gobburu
The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity.
Journal of clinical pharmacology 2007;47(1):78-86.
2005: Venkatesh Atul Bhattaram; Brian P Booth; Roshni P Ramchandani; B Nhi Beasley; Yaning Wang; Veneeta Tandon; John Z Duan; Raman K Baweja; Patrick J Marroum; Ramana S Uppoor; Nam Atiqur Rahman; Chandra Sahajwalla; J Robert Powell; Mehul U Mehta; Jogarao V S Gobburu
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
The AAPS journal 2005;7(3):E503-12.