Honghui Zhou

Amarnath Sharma, Honghui Zhou, Shu Li, 2019, Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases.

Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients

H. Nahi, C. Touzeau, Yu‐Nien Sun, 2020, Journal of clinical pharmacology.

Information contributed by meta-analysis in exposure–response modeling: application to phase 2 dose selection of guselkumab in patients with moderate-to-severe psoriasis

Y. Wasfi, Honghui Zhou, Chuanpu Hu, 2014, Journal of Pharmacokinetics and Pharmacodynamics.

Amphiregulin from Basophils Ampliﬁes Basophil-Mediated Chronic Skin Inﬂammation

Honghui Zhou, Shu Li, J. Marini, 2019 .

Joint longitudinal model development: application to exposure–response modeling of ACR and DAS scores in rheumatoid arthritis patients treated with sirukumab

B. Hsu, Amarnath Sharma, Honghui Zhou, 2018, Journal of Pharmacokinetics and Pharmacodynamics.

Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations

Honghui Zhou, Zhenhua Xu, Katherine Y. Berezny, 2022, Pediatric Drugs.

A Pharmacokinetic Study of Intravenous Itraconazole Followed by Oral Administration of Itraconazole Capsules in Patients with Advanced Human Immunodeficiency Virus Infection

Honghui Zhou, A. Baruch, R. Woestenborghs, 1998, Journal of clinical pharmacology.

Pharmacokinetics of Intravenous Itraconazole followed by Itraconazole Oral Solution in Patients with Human Immunodeficiency Virus Infection

Qinying Zhao, Honghui Zhou, L. Pesco‐Koplowitz, 2001, Journal of clinical pharmacology.

Risk factors for candida infection of the genital tract in the tropics.

Honghui Zhou, E. Zhao, Z. Xiao, 2015, African health sciences.

Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, immunogenicity, efficacy and safety

Honghui Zhou, Zhenhua Xu, H. Davis, 2015, Journal of clinical pharmacology.

Population‐Based Assessments of Clinical Drug‐Drug Interactions: Qualitative Indices or Quantitative Measures?

Honghui Zhou, Honghui Zhou, 2006, Journal of clinical pharmacology.

Cross-arm binding efficiency of an EGFR x c-Met bispecific antibody

M. Chiu, Honghui Zhou, Songmao Zheng, 2016, mAbs.

Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α

Bill Pikounis, Honghui Zhou, Peter J. Bugelski, 2010, mAbs.

Impact of withdrawal and retreatment on immunogenicity of guselkumab in patients with moderate-to-severe plaque psoriasis

M. Song, Y. Wasfi, Honghui Zhou, 2018, Journal of the American Academy of Dermatology.

Therapeutic targeting of the IL-12/23 pathways: generation and characterization of ustekinumab

Honghui Zhou, Gopi Shankar, G. Shankar, 2011, Nature Biotechnology.

Pharmacokinetics and Safety of Golimumab in Healthy Chinese Subjects Following a Single Subcutaneous Administration in a Randomized Phase I Trial

Y. Lv, Honghui Zhou, Zhenhua Xu, 2013, Clinical Drug Investigation.

Golimumab pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: an open-label, randomized study.

B. Frederick, Honghui Zhou, Zhenhua Xu, 2012, Clinical therapeutics.

Population Pharmacokinetics of Golimumab, an Anti‐Tumor Necrosis Factor‐α Human Monoclonal Antibody, in Patients With Psoriatic Arthritis

C. Wagner, Honghui Zhou, T. Vu, 2009, Journal of clinical pharmacology.

Population Pharmacokinetic Analysis and Simulation of the Time‐Concentration Profile of Etanercept in Pediatric Patients With Juvenile Rheumatoid Arthritis

I. Nestorov, C. Peck, D. Yim, 2005, Journal of clinical pharmacology.

Population Pharmacokinetics of Infliximab in Patients With Ankylosing Spondylitis

Honghui Zhou, Zhenhua Xu, H. Davis, 2008, Journal of clinical pharmacology.

Unaltered Etanercept Pharmacokinetics With Concurrent Methotrexate in Patients With Rheumatoid Arthritis

Honghui Zhou, Honghui Zhou, J. Wajdula, 2004, Journal of clinical pharmacology.

Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis.

P. Rutgeerts, W. Sandborn, W. Reinisch, 2014, Gastroenterology.

Utilizing pharmacokinetics/pharmacodynamics modeling to simultaneously examine free CCL2, total CCL2 and carlumab (CNTO 888) concentration time data

A. Tolcher, C. Takimoto, J. D. de Bono, 2013, Journal of clinical pharmacology.

Trial Design and Statistical Considerations on the Assessment of Pharmacodynamic Similarity

Jason J. Z. Liao, J. Liao, Honghui Zhou, 2019, The AAPS Journal.

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

F. Theil, Honghui Zhou, 2015 .

Characterizing the Impact of Renal Impairment on the Clinical Pharmacology of Biologics

B. Meibohm, Honghui Zhou, 2012, Journal of clinical pharmacology.

In Vivo Evaluation of Oral Dosage Form Performance

Honghui Zhou, K. Seitz, 2009 .

Landmark and longitudinal exposure–response analyses in drug development

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

Honghui Zhou, Q. Jiao, H. Davis, 2009, Journal of clinical pharmacology.

Application of Beta-Distribution and Combined Uniform and Binomial Methods in Longitudinal Modeling of Bounded Outcome Score Data

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2020, The AAPS Journal.

Comparison of the Pharmacokinetics of Subcutaneous Ustekinumab between Chinese and Non-Chinese Healthy Male Subjects across Two Phase 1 Studies

B. Frederick, Honghui Zhou, J. Marini, 2013, Clinical Drug Investigation.

De-risking bio-therapeutics for possible drug interactions using cryopreserved human hepatocytes.

Honghui Zhou, S. Dallas, M. Markowska, 2012, Current drug metabolism.

Early M‐Protein Dynamics Predicts Progression‐Free Survival in Patients With Relapsed/Refractory Multiple Myeloma

M. Dimopoulos, P. Sonneveld, Honghui Zhou, 2020, Clinical and translational science.

Population Pharmacokinetics and Exposure‐Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light‐Chain Amyloidosis

E. Kastritis, G. Merlini, Yu‐Nien Sun, 2021, Journal of clinical pharmacology.

Influence of Disease and Patient Characteristics on Daratumumab Exposure and Clinical Outcomes in Relapsed or Refractory Multiple Myeloma

S. Lonial, P. Richardson, T. Plesner, 2017, Clinical Pharmacokinetics.

Informative dropout modeling of longitudinal ordered categorical data and model validation: application to exposure–response modeling of physician’s global assessment score for ustekinumab in patients with psoriasis

Chuanpu Hu, Honghui Zhou, Honghui Zhou, 2011, Journal of Pharmacokinetics and Pharmacodynamics.

What We Can Learn from Current Inflammatory Bowel Disease (IBD) Biological Therapy—Dose Regimen and Others

Honghui Zhou, Yan Xu, Yang Chen, 2019, Current Pharmacology Reports.

Population Pharmacokinetics and Exposure‐Response Modeling Analyses of Ustekinumab in Adults With Moderately to Severely Active Ulcerative Colitis

Amarnath Sharma, Honghui Zhou, Zhenhua Xu, 2020, Journal of clinical pharmacology.

Molecular, Biologic, and Pharmacokinetic Properties of Monoclonal Antibodies: Impact of These Parameters on Early Clinical Development

M. Mascelli, D. Abernethy, R. Sweet, 2007, Journal of clinical pharmacology.

Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver

Honghui Zhou, Chuanpu Hu, P. Zhu, 2020, The AAPS Journal.

Effect of Meal Timing Not Critical for the Pharmacokinetics of Tegaserod (HTF 919)

Honghui Zhou, M. Guerret, H. Lau, 1999, Journal of clinical pharmacology.

First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis

Honghui Zhou, Zhenhua Xu, S. Marciniak, 2016, European Journal of Clinical Pharmacology.

Absence of a Pharmacokinetic Interaction between Etanercept and Warfarin

A. Patat, Honghui Zhou, J. Korth-Bradley, 2004, Journal of clinical pharmacology.

Towards patient stratification and treatment in the autoimmune disease lupus erythematosus using a systems pharmacology approach.

An Vermeulen, Chuanpu Hu, Honghui Zhou, 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Mechanisms of monoclonal antibody-drug interactions.

Honghui Zhou, M. Mascelli, Honghui Zhou, 2011, Annual review of pharmacology and toxicology.

AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development

Steven W. Martin, Shiew-Mei Huang, R. Evers, 2011, The AAPS Journal.

Deciphering the In Vivo Performance of a Monoclonal Antibody to Neutralize Its Soluble Target at the Site of Action in a Mouse Collagen-Induced Arthritis Model

Honghui Zhou, Weirong Wang, Xiling Jiang, 2016, Pharmaceutical Research.

Chapter 15 – Bioavailability and Bioequivalence

Honghui Zhou, Hao Zhu, K. Seitz, 2009 .

The quest for balance between capturing data and model complexity: A quantitative clinical pharmacology approach applied to monoclonal antibodies

L. Peletier, V. D. Sharma, Honghui Zhou, 2023, CPT: pharmacometrics & systems pharmacology.

Population Pharmacokinetics/Toxicodynamics (PK/TD) Relationship of SAM486A in Phase I Studies in Patients with Advanced Cancers

J. Verweij, Honghui Zhou, R. Capdeville, 2000, Journal of clinical pharmacology.

Development of the IL‐12/23 antagonist ustekinumab in psoriasis: past, present, and future perspectives

M. Mascelli, Honghui Zhou, M. Plotnick, 2011, Annals of the New York Academy of Sciences.

“Cocktail” Approaches and Strategies in Drug Development: Valuable Tool or Flawed Science?

Honghui Zhou, Honghui Zhou, Zeen Tong, 2004, Journal of clinical pharmacology.

Population Approach for Exposure‐Response Modeling of Golimumab in Patients With Rheumatoid Arthritis

Mahboob Rahman, Honghui Zhou, Zhenhua Xu, 2011, Journal of clinical pharmacology.

Facilitating Longitudinal Exposure-Response Modeling of a Composite Endpoint Using the Joint Modeling of Sparsely and Frequently Collected Subcomponents

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2020, The AAPS Journal.

Lack of Effect of Erythromycin and Ketoconazole on the Pharmacokinetics and Pharmacodynamics of Steady‐State Intranasal Levocabastine

Honghui Zhou, S. Travers, B. Wiesinger, 1999, Journal of clinical pharmacology.

Target-Mediated Drug Disposition of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma after Prior Proteasome Inhibitors and Immunomodulatory Drugs: A Population Pharmacokinetic Analysis

S. Lonial, R. Orlowski, Honghui Zhou, 2015 .

Pharmacokinetics of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma (MM) after Prior Proteasome Inhibitor (PI) and Immunomodulatory Drug (IMiD) Treatment

S. Lonial, Honghui Zhou, H. Lokhorst, 2015 .

A comprehensive evaluation of exposure–response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis

Amarnath Sharma, Honghui Zhou, Zhenhua Xu, 2018, Journal of Pharmacokinetics and Pharmacodynamics.

The Effects of Tegaserod (HTF 919) on the Pharmacokinetics and Pharmacodynamics of Digoxin in Healthy Subjects

Honghui Zhou, M. Hubert, J. McLeod, 2001, Journal of clinical pharmacology.

A phase 1, randomized study to assess the pharmacokinetic comparability of siltuximab derived from two different cell lines in healthy subjects

B. Frederick, Honghui Zhou, J. Marini, 2014, Clinical pharmacology in drug development.

A Novel Approach to Evaluate the Pharmacokinetic Biocomparability of a Monoclonal Antibody Derived from Two Different Cell Lines Using Simultaneous Crossover Design

Brian J. Geist, Honghui Zhou, C. Pendley, 2013, The AAPS Journal.

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

Justin C. Earp, R. Evers, Lei Zhang, 2013, The AAPS Journal.

Investigation of the Mechanism of Therapeutic Protein-Drug Interaction Between Methotrexate and Golimumab, an Anti-TNFα Monoclonal Antibody

Honghui Zhou, Weirong Wang, Zhenhua Xu, 2018, The AAPS Journal.

Confirmatory analysis for phase III population pharmacokinetics

Chuanpu Hu, Honghui Zhou, Ji Zhang, 2011, Pharmaceutical statistics.

Drug Interactions for Therapeutic Proteins: A Journey Just Beginning

B. Meibohm, Honghui Zhou, 2013 .

Absence of a Clinically Relevant Interaction Between Etanercept and Digoxin

A. Patat, D. Simcoe, Honghui Zhou, 2004, Journal of clinical pharmacology.

Immunogenicity of Guselkumab Is Not Clinically Relevant in Patients with Moderate-to-Severe Plaque Psoriasis.

Honghui Zhou, Shu Li, J. Marini, 2019, The Journal of investigative dermatology.

Bounded outcome score modeling: application to treating psoriasis with ustekinumab

Honghui Zhou, N. Yeilding, H. Davis, 2011, Journal of Pharmacokinetics and Pharmacodynamics.

Improvement in latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint in rheumatoid arthritis

Honghui Zhou, Chuanpu Hu, 2016, Journal of Pharmacokinetics and Pharmacodynamics.

Development of a Physiologically Based Pharmacokinetic Model to Predict Disease-Mediated Therapeutic Protein–Drug Interactions: Modulation of Multiple Cytochrome P450 Enzymes by Interleukin-6

Honghui Zhou, Weirong Wang, Zhenhua Xu, 2016, The AAPS Journal.

Improving categorical endpoint longitudinal exposure–response modeling through the joint modeling with a related endpoint

Honghui Zhou, Chuanpu Hu, 2021, Journal of Pharmacokinetics and Pharmacodynamics.

Modeling near-continuous clinical endpoint as categorical: application to longitudinal exposure–response modeling of Mayo scores for golimumab in patients with ulcerative colitis

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2018, Journal of Pharmacokinetics and Pharmacodynamics.

Challenges in longitudinal exposure-response modeling of data from complex study designs: a case study of modeling CDAI score for ustekinumab in patients with Crohn’s disease

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

Translational Model‐Informed Dose Selection for a Human Positron Emission Tomography Imaging Study of JNJ‐54175446, a P2X7 Receptor Antagonist

Honghui Zhou, P. Nandy, Yan Xu, 2019, Clinical and translational science.

Mechanistic Pharmacokinetic/Target Engagement/Pharmacodynamic (PK/TE/PD) Modeling in Deciphering Interplay Between a Monoclonal Antibody and Its Soluble Target in Cynomolgus Monkeys

Honghui Zhou, Weirong Wang, Xiaofeng Wang, 2013, The AAPS Journal.

Population pharmacokinetics and exposure–response analyses of daratumumab plus pomalidomide/dexamethasone in relapsed or refractory multiple myeloma

P. Sonneveld, J. P. Perez Ruixo, E. Terpos, 2022, British journal of clinical pharmacology.

Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses

A. Jakubowiak, A. Krishnan, S. Lonial, 2020, Advances in Therapy.

Model‐Based Investigation of Inadequate Efficacy of Tesnatilimab, an Anti–Natural Killer Group 2 Member D Monoclonal Antibody, in Moderately to Severely Active Crohn Disease

Jie Zhou, Yaming Su, Honghui Zhou, 2023, Journal of clinical pharmacology.

Population Pharmacokinetic and Exposure-Response Model Simulations: Predicted Exposure and Efficacy for Maintenance Doses of Intravenous Golimumab Every 6 or 8 Weeks in Patients With Moderately to Severely Active Rheumatoid Arthritis.

Honghui Zhou, S. Chakravarty, Zhenhua Xu, 2022, Clinical therapeutics.

Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects.

Y. Tsukamoto, Honghui Zhou, Zhenhua Xu, 2013, International journal of clinical pharmacology and therapeutics.

A Phase 1 First‐in‐Human Pharmacokinetic and Pharmacodynamic Study of JNJ‐64264681, a Covalent Inhibitor of Bruton's Tyrosine Kinase

Bonnie Wu, Carol F. Franks, Honghui Zhou, 2023, Clinical pharmacology in drug development.

Should Clinical Pharmacokinetic Bridging Studies Between Caucasian and Asian Populations Be Required for Approval of Monoclonal Antibodies?

Y. Tsukamoto, Honghui Zhou, H. Davis, 2012, Journal of clinical pharmacology.

Model‐Aided Adults‐to‐Children Pharmacokinetic Extrapolation and Empirical Body Size‐Based Dosing Exploration for Therapeutic Monoclonal Antibodies—Is Allometry a Reasonable Choice?

Honghui Zhou, Zhenhua Xu, Yan Xu, 2020, Journal of clinical pharmacology.

Muscle disorders111. The impact of fatigue in patients with idiopathic inflammatory myopathy: a mixed method study

R. Moots, P. Salkovskis, Yulia Goryachev, 2012 .

Nateglinide, a New Mealtime Glucose Regulator

Honghui Zhou, D. Devineni, Yulia H. Walter, 2000 .

Clinical Implications of Complex Pharmacokinetics for Daratumumab Dose Regimen in Patients With Relapsed/Refractory Multiple Myeloma

S. Lonial, T. Plesner, P. Voorhees, 2017, Clinical pharmacology and therapeutics.

Pharmacokinetic bridging approach for developing biologics-delivery devices: a case study with a golimumab autoinjector.

B. Frederick, Honghui Zhou, Zhenhua Xu, 2015, Clinical therapeutics.

Applying Beta Distribution in Analyzing Bounded Outcome Score Data

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2020, AAPS Journal.

Improvement in latent variable indirect response modeling of multiple categorical clinical endpoints: application to modeling of guselkumab treatment effects in psoriatic patients

Amarnath Sharma, Honghui Zhou, Chuanpu Hu, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

Latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint

Honghui Zhou, Chuanpu Hu, A. Mendelsohn, 2014, Journal of Pharmacokinetics and Pharmacodynamics.

Latent variable indirect response modeling of categorical endpoints representing change from baseline

Honghui Zhou, Zhenhua Xu, Chuanpu Hu, 2013, Journal of Pharmacokinetics and Pharmacodynamics.

Evaluating Potential Disease‐Mediated Protein‐Drug Interactions in Patients With Moderate‐to‐Severe Plaque Psoriasis Receiving Subcutaneous Guselkumab

Amarnath Sharma, Honghui Zhou, Zhenhua Xu, 2020, Clinical and translational science.

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

Honghui Zhou, Q. Jiao, H. Davis, 2009, Journal of clinical pharmacology.

Trial Design and Statistical Considerations on the Assessment of Pharmacodynamic Similarity

Jason J. Z. Liao, Honghui Zhou, P. Zhu, 2019, The AAPS Journal.

Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, immunogenicity, efficacy and safety

Honghui Zhou, Zhenhua Xu, H. Davis, 2015, Journal of clinical pharmacology.

Cross-arm binding efficiency of an EGFR x c-Met bispecific antibody

M. Chiu, Honghui Zhou, Songmao Zheng, 2016, mAbs.

Towards patient stratification and treatment in the autoimmune disease lupus erythematosus using a systems pharmacology approach.

M. L. Ruiz-Cerdá, I. Trocóniz, Honghui Zhou, 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Tegaserod (HTF 919) does not decrease the effectiveness of an oral contraceptive when coadministered to healthy female subjects

Honghui Zhou, M. Hubert, Peiming Ma, 2000 .

Tegaserod Pharmacokinetics Are Similar in Patients with Severe Renal Insufficiency and in Healthy Subjects

S. Swan, Honghui Zhou, M. Hubert, 2003, Journal of clinical pharmacology.

Investigation of the Mechanism of Therapeutic Protein-Drug Interaction Between Methotrexate and Golimumab, an Anti-TNFα Monoclonal Antibody

Honghui Zhou, Weirong Wang, Zhenhua Xu, 2018, The AAPS Journal.

Risk factors for candida infection of the genital tract in the tropics.

Honghui Zhou, E. Zhao, Z. Xiao, 2015, African health sciences.

Honghui Zhou, Zhenhua Xu, S. Marciniak, 2015, Journal of clinical pharmacology.

Highlights From a Recent BIO Survey on Therapeutic Protein‐Drug Interactions

F. Theil, I. Nestorov, Honghui Zhou, 2012, Journal of clinical pharmacology.

Statistical Considerations in Assessing Drug–Drug Interactions for Therapeutic Biologics

Honghui Zhou, Chuanpu Hu, 2013 .

Pharmacokinetic bridging approach for developing biologics-delivery devices: a case study with a golimumab autoinjector.

B. Frederick, Honghui Zhou, Zhenhua Xu, 2015, Clinical therapeutics.

Full covariate modelling approach in population pharmacokinetics: understanding the underlying hypothesis tests and implications of multiplicity

Jinfeng Xu, Yaning Yang, Honghui Zhou, 2018, British journal of clinical pharmacology.