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  1. Article

    Open Access

    Population Target-Mediated Pharmacokinetic/Pharmacodynamic Modeling to Evaluate SPI-62 Exposure and Hepatic 11β-Hydroxysteroid Dehydrogenase Type 1 (HSD-1) Inhibition in Healthy Adults

    SPI-62 is a small-molecule 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor exhibiting complicated nonlinear pharmacokinetics (PK) in human. Previously, we developed a target-mediated drug disposition...

    Nan Wu, David A. Katz, Guohua An in Clinical Pharmacokinetics (2023)

  2. No Access

    Article

    A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological Target Hemoglobin With Positive Cooperative Binding

    In general, small-molecule target-mediated drug disposition (TMDD) is caused by the interaction of a drug with its high-affinity, low-capacity pharmacological target. In the current work, we developed a pharma...

    Min Xu, Guohua An in The AAPS Journal (2023)

  3. No Access

    Article

    Pharmacometric model of agalsidase–migalastat interaction in human: a novel mechanistic model of drug-drug interaction between a therapeutic protein and a small molecule

    Recently, a new mechanism of drug–drug interaction (DDI) was reported between agalsidase, a therapeutic protein, and migalastat, a small molecule, both of which are treatment options of Fabry disease. Migalast...

    Thanh Bach, Nan Wu, Guohua An in Journal of Pharmacokinetics and Pharmacodynamics (2023)

  4. No Access

    Article

    Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan

    Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. Using an opportunistic study design, we evaluated the pharmacokinetics of piperacillin/tazobactam as a probe drug to e...

    Marion Hemmersbach-Miller, Stephen J. Balevic in Clinical Pharmacokinetics (2023)

  5. No Access

    Article

    Comparing the performance of first-order conditional estimation (FOCE) and different expectation–maximization (EM) methods in NONMEM: real data experience with complex nonlinear parent-metabolite pharmacokinetic model

    First-order conditional estimation (FOCE) has been the most frequently used estimation method in NONMEM, a leading program for population pharmacokinetic/pharmacodynamic modeling. However, with growing data co...

    Thanh Bach, Guohua An in Journal of Pharmacokinetics and Pharmacodynamics (2021)

  6. No Access

    Article

    The Utility of Pharmacometric Models in Clinical Pharmacology Research in Infants

    Acquiring knowledge on drug disposition and action in infant is challenging because of the problem of sparse and unbalanced data obtained for each individual infant due to the limited blood volume as well as t...

    Guohua An in Current Pharmacology Reports (2020)

  7. No Access

    Article

    Incorporating Pharmacological Target-Mediated Drug Disposition (TMDD) in a Whole-Body Physiologically Based Pharmacokinetic (PBPK) Model of Linagliptin in Rat and Scale-up to Human

    Linagliptin demonstrates substantial nonlinear pharmacokinetics due to its saturable binding to its pharmacological target dipeptidyl peptide 4 (DPP-4), a phenomenon known as target-mediated drug disposition (...

    Nan Wu, Guohua An in The AAPS Journal (2020)

  8. No Access

    Article

    Overlooked Issues on Pharmacokinetics Data Interpretation of Protein Drugs—a Case Example of Erythropoietin

    Guohua An, Robert L. Schmidt, Donald M. Mock, Peter Veng-Pedersen in The AAPS Journal (2018)

  9. Article

    A new method to evaluate the dose-effect relationship of a TCM formula Gegen Qinlian Decoction: “Focus” mode of integrated biomarkers

    It is difficult to accurately evaluate the efficacy of traditional Chinese medicine (TCM), which leads to the uncertainty and complexity of dose-effect analysis. In this study we established the “Focus” mode o...

    Zhi-qiang Huang, Xue-mei Fan, Yi-ming Wang, Qiong-lin Liang in Acta Pharmacologica Sinica (2017)

  10. No Access

    Article

    A Novel Physiology-Based Mathematical Model to Estimate Red Blood Cell Lifespan in Different Human Age Groups

    Direct measurement of red blood cell (RBC) survival in humans has improved from the original accurate but limited differential agglutination technique to the current reliable, safe, and accurate biotin method....

    Guohua An, John A. Widness, Donald M. Mock, Peter Veng-Pedersen in The AAPS Journal (2016)

  11. Article

    A Whole-Body Physiologically Based Pharmacokinetic Model of Gefitinib in Mice and Scale-Up to Humans

    Gefitinib (Iressa) is a selective and potent EGFR tyrosine kinase inhibitor. It received an accelerated FDA approval in 2003 for the treatment of patients with nonsmall cell lung cancer (NSCLC) and represents ...

    Youwei Bi, Jiexin Deng, Daryl J. Murry, Guohua An in The AAPS Journal (2016)

  12. Article

    Erratum to: Population Pharmacokinetics and Exposure-Uric Acid Analyses After Single and Multiple Doses of ABT-639, a Calcium Channel Blocker, in Healthy Volunteers

    Guohua An, Wei Liu, W. Rachel Duan, Wolfram Nothaft, Walid Awni in The AAPS Journal (2015)

  13. No Access

    Article

    Population Pharmacokinetics and Exposure-Uric Acid Analyses After Single and Multiple Doses of ABT-639, a Calcium Channel Blocker, in Healthy Volunteers

    ABT-639 is a selective T-type calcium channel blocker with efficacy in a wide range of preclinical models of nociceptive and neuropathic pain. In the current first-in-human (FIH) study, the pharmacokinetics, t...

    Guohua An, Wei Liu, W. Rachel Duan, Wolfram Nothaft, Walid Awni in The AAPS Journal (2015)

  14. No Access

    Article

    ABC Transporters in Multi-Drug Resistance and ADME-Tox of Small Molecule Tyrosine Kinase Inhibitors

    The past decade has seen tremendous efforts in the research and development of new chemotherapeutic drugs using target-based approaches. These efforts have led to the discovery of small molecule tyrosine kinas...

    Jiexin Deng, Jie Shao, John S. Markowitz, Guohua An in Pharmaceutical Research (2014)

  15. No Access

    Article

    A Physiologically Based Pharmacokinetic Model of Mitoxantrone in Mice and Scale-up to Humans: a Semi-Mechanistic Model Incorporating DNA and Protein Binding

    We conducted a pharmacokinetic (PK) study of mitoxantrone (Novantrone®), a clinically well-established anticancer agent, in mice and developed a mechanism-based PBPK (physiologically based pharmacokinetic) mod...

    Guohua An, Marilyn E. Morris in The AAPS Journal (2012)

  16. No Access

    Article

    5,7-Dimethoxyflavone and Multiple Flavonoids in Combination Alter the ABCG2-Mediated Tissue Distribution of Mitoxantrone in Mice

    The objective of our study was to investigate the effect of 5,7-DMF on the accumulation of mitoxantrone (MX) in BCRP-expressing normal cells and to investigate its impact on the PK and tissue distribution of M...

    Guohua An, Fang Wu, Marilyn E. Morris in Pharmaceutical Research (2011)

  17. No Access

    Article

    Laevigatbenzoate from Croton laevigatus Vahl.

    A new trans-clerodane diterpenoid, laevigatbenzoate (1), was isolated from the leaves of Croton laevigatus Vahl. Its structure was established on the basis of spectroscopic analysis, and the absolute configuratio...

    Guo-An Zou, Hong-Wu Zhang, Haji Akber Aisa, Jun-Shan Yang in Journal of Natural Medicines (2011)

  18. No Access

    Article

    Effects of Single and Multiple Flavonoids on BCRP-Mediated Accumulation, Cytotoxicity and Transport of Mitoxantrone In Vitro

    The objective of our study was to investigate the effect of single and multiple flavonoids on the accumulation and cytotoxicity of mitoxantrone in BCRP-overexpressing breast cancer cells and on the transport o...

    Guohua An, Marilyn E. Morris in Pharmaceutical Research (2010)

  19. No Access

    Article

    Investigation on pharmacokinetics, tissue distribution and excretion of a novel anticancer platinum compound by inductively coupled plasma mass spectrometry after intravenous administration to rats

    SM54111 [cis-3, 5-diisopropylsalylic cyclohexanodiaminoplatinum (II), Saliplatin] is a novel platinum compound with encouraging anticancer effect. In order to get more useful information in multiple species fo...

    Qing-fei Liu, Xue Li, Qiang Su, Guo-an Luo, Yi-ming Wang in Archives of Pharmacal Research (2009)

  20. Article

    The Retention Behavior of Ginsenosides in HPLC and Its Application to Quality Assessment of Radix Ginseng

    ** Hu, Guo-An Luo, Qing Wang, Zhong-Zhen Zhao, Wan Wang in Archives of Pharmacal Research (2009)

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