Q
Qi Liu
Researcher at Center for Drug Evaluation and Research
Publications - 21
Citations - 1638
Qi Liu is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Medicine & Drug development. The author has an hindex of 11, co-authored 14 publications receiving 1329 citations.
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Journal ArticleDOI
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.
Ping Zhao,Lei Zhang,Joseph A. Grillo,Qi Liu,Julie Bullock,Y. J. Moon,P. Song,S. S. Brar,Rajnikanth Madabushi,T. C. Wu,Brian Booth,Nam Atiqur Rahman,Kellie S. Reynolds,E Gil Berglund,Lawrence J. Lesko,Huang Sm +15 more
TL;DR: Recent instances of the use of PBPK in decision‐making during regulatory review are reviewed, based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs and new drug applications received between July 2008 and June 2010.
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FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer
Julia A. Beaver,Laleh Amiri-Kordestani,Rosane Charlab,Wei Chen,Todd R. Palmby,Amy Tilley,Jeanne Fourie Zirkelbach,Jingyu Yu,Qi Liu,Liang Zhao,Joyce Z. Crich,Xiao Hong Chen,Minerva Hughes,Erik Bloomquist,Shenghui Tang,Rajeshwari Sridhara,Paul G. Kluetz,Geoffrey Kim,Amna Ibrahim,Richard Pazdur,Patricia Cortazar +20 more
TL;DR: The FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMa-2 are summarized.
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FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer
Laleh Amiri-Kordestani,Gideon M. Blumenthal,Qiang Casey Xu,Lijun Zhang,Shenghui W. Tang,Linan Ha,Wendy C. Weinberg,Bo Chi,Reyes Candau-Chacon,Patricia Hughes,Anne Marie Russell,Sarah Pope Miksinski,Xiao Hong Chen,W. David McGuinn,Todd R. Palmby,Sarah J. Schrieber,Qi Liu,Jian Wang,Pengfei Song,Nitin Mehrotra,Lisa Skarupa,Kathleen A. Clouse,Ali Al-Hakim,Rajeshwari Sridhara,Amna Ibrahim,Robert Justice,Richard Pazdur,Patricia Cortazar +27 more
TL;DR: The most common adverse reactions in patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation.
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FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
Geoffrey Kim,Amy E. McKee,Yang-Min Ning,Maitreyee Hazarika,Marc R. Theoret,John R. Johnson,Qiang Casey Xu,Shenghui Tang,Rajeshwari Sridhara,Xiaoping Jiang,Kun He,Donna Roscoe,W. David McGuinn,Whitney S. Helms,Anne Marie Russell,Sarah Pope Miksinski,Jeanne Fourie Zirkelbach,Justin C. Earp,Qi Liu,Amna Ibrahim,Robert Justice,Richard Pazdur +21 more
TL;DR: The most common adverse reactions in patients treated with vemurafenib were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, and nausea, and other adverse reactions included hypersensitivity, Stevens–Johnson syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and liver enzyme laboratory abnormalities.
Journal ArticleDOI
FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Amanda J. Walker,Suparna Wedam,Laleh Amiri-Kordestani,Erik Bloomquist,Shenghui Tang,Rajeshwari Sridhara,Wei Chen,Todd R. Palmby,Jeanne Fourie Zirkelbach,Wentao Fu,Qi Liu,Amy Tilley,Geoffrey Kim,Paul G. Kluetz,Amy E. McKee,Richard Pazdur +15 more
TL;DR: On February 19, 2016, the FDA approved palbociclib for use in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.