11 Papers
34 Citations
He Sun is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Population & QT interval. The author has an hindex of 8, co-authored 11 publications.
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Papers
Population pharmacokinetics. A regulatory perspective.
He Sun,Emmanuel Fadiran,Carolyn D. Jones,Lawrence J. Lesko,Shiew-Mei Huang,Karen Higgins,Chuanpu Hu,Stella Machado,Samuel Maldonado,Roger Williams,Mohammad Awlad Hossain,Ene I. Ette +11 more
TL;DR: The 2-stage approach to the estimation of population pharmacokinetic parameters is discussed, and the nonlinear mixed-effects modelling approach is reviewed, which can be applied in situations where extensive sampling is not done on all or any of the participants.
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Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004–2006
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 +10 more
TL;DR: Overall, industry and FDA scientists ranked these meetings to be “very helpful” (average score of 4 on a scale of 1 to 5) and in almost all the instances the sponsors changed their drug development plans subsequent to these extensive quantitative analyses‐based meetings.
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Adverse Drug Reactions: A Review of Relevant Factors
TL;DR: Assessment of the postmarketing ADR data for 22 drugs revealed that drugs with high potential for eliciting clinically significant ADRs are usually detected and either withdrawn from the market or placed on restricted use within the first year or two of marketing.
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The Process of Knowledge Discovery from Large Pharmacokinetic Data Sets
TL;DR: The advent of statistical software with powerful graphical and modeling capabilities has revolutionized the manner in which pharmacokinetic and pharmacodynamic analyses are performed, giving the data analyst the freedom to choose statistical methodology appropriate to the problem at hand with the maximization of information extraction.
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Designing Cross-Sectional Population Pharmacokinetic Studies: Implications for Pediatric and Animal Studies
C. D. Jones,He Sun,Ene I. Ette +2 more
TL;DR: A simulation study was carried out to investigate the effect of optimization of design features on the accuracy and precision of parameter estimation in cross-sectional population pharmacokinetic studies involving drugs administered by single or multiple intravenous bolus input(s).
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