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He Sun

Center for Drug Evaluation and Research

9

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Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations : Impact of FDA Pharmacometrics During 2004-2006

2008 The Journal of Clinical Pharmacology
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Frequency of QT recording and the reliability of QT prolongation assessments

2004 Clinical Pharmacology & Therapeutics
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The process of knowledge discovery from large pharmacokinetic data sets.

2001 The Journal of Clinical Pharmacology
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Adverse drug reactions: A review of relevant factors

2000 The Journal of Clinical Pharmacology
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Ignorability and Parameter Estimation in Longitudinal Pharmacokinetic Studies

1998 The Journal of Clinical Pharmacology
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Preclinical pharmacology of the natural product anticancer agent 10-hydroxycamptothecin, an inhibitor of topoisomerase I

1998 Cancer Chemotherapy and Pharmacology
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FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

1997 Dissolution Technologies
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A pharmacokinetic/pharmacodynamic (PK/PD) model describing the combined effects of feedback, regulation and complexation (FRC) process.

1996 Clinical Pharmacology & Therapeutics
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