Yow-Ming C Wang

发表

Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins.

S. J. Schrieber, Justin C. Earp, Yaning Wang, 2019, Journal of pharmaceutical sciences.

Development of Biosimilars—Pharmacokinetic and Pharmacodynamic Considerations

Yow-Ming C Wang, A. Chow, Andrew T Chow, 2009, Journal of biopharmaceutical statistics.

Romiplostim dose-response in patients with myelodysplastic syndromes.

Yow-Ming C Wang, D. Mould, J. P. Perez Ruixo, 2013, British journal of clinical pharmacology.

Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim in Animals

Yow-Ming C Wang, J. Pérez-Ruixo, A. Chow, 2013, Pharmaceutical Research.

Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis.

Mark Ma, Vibha Jawa, Yow-Ming C Wang, 2014, Bioanalysis.

Biological Products for the Treatment of Psoriasis: Therapeutic Targets, Pharmacodynamics and Disease-Drug-Drug Interaction Implications

Yow-Ming C Wang, Jie Wang, H. Ahn, 2014, The AAPS Journal.

Pharmacokinetics of Anti-hepcidin Monoclonal Antibody Ab 12B9m and Hepcidin in Cynomolgus Monkeys

Yow-Ming C Wang, J. Pérez-Ruixo, Yuling Wu, 2010, The AAPS Journal.

A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays

Yow-Ming C Wang, L. Fang, Jie Wang, 2012, Pharmaceutical Research.

Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium

Yow-Ming C Wang, B. Desilva, M. Rose, 2014, The AAPS Journal.

Pharmacokinetic and pharmacodynamic considerations in the development of biotechnology products and large molecules

Yow-Ming C Wang, P. Garzone, P. D. Garzone, 2022, Atkinson's Principles of Clinical Pharmacology.

Population Pharmacokinetic Analysis of Panitumumab in Patients With Advanced Solid Tumors

Yow-Ming C Wang, A. Chow, Bing‐Bing Yang, 2009, Journal of clinical pharmacology.

Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies.

Yow-Ming C Wang, S. Prabhu, M. Subramanyam, 2010, Trends in biotechnology.

c-Jun N-Terminal Kinases Mediate Reactivation of Akt and Cardiomyocyte Survival After Hypoxic Injury In Vitro and In Vivo

Yow-Ming C Wang, F. Salituro, P. Tsichlis, 2005, Circulation research.

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, B

Yow-Ming C Wang, Andrew P Mayer, M. Fiscella, 2019, Bioanalysis.

Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report

Lauren F Stevenson, Yow-Ming C Wang, V. Devanarayan, 2022, AAPS Open.

Immune response to enzyme replacement therapies in lysosomal storage diseases and the role of immune tolerance induction.

Yow-Ming C Wang, Anne R. Pariser, J. Bluestone, 2016, Molecular Genetics and Metabolism.

Changing the drug development and therapeutic paradigm with biologic drug combinations and bispecifics: How to choose between these two approaches?

Yow-Ming C Wang, Songmao Zheng, R. Prell, 2022, Clinical and translational science.

Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with lower risk myelodysplastic syndromes

Yow-Ming C Wang, H. Kantarjian, P. Fenaux, 2011, Cancer.

A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia.

Yow-Ming C Wang, J. Bussel, V. Blanchette, 2011, Blood.

Individualized Dosing of Therapeutic Monoclonal Antibodies—a Changing Treatment Paradigm?

Yow-Ming C Wang, D. Mould, L. Ruff, 2018, The AAPS Journal.

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

Yow-Ming C Wang, Y. Hon, L. Fang, 2015, The AAPS Journal.

Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions.

Yow-Ming C Wang, D. Strauss, Shiew-Mei Huang, 2019, Biomarkers in medicine.

Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation.

Yow-Ming C Wang, I. Zineh, Eric Brodsky, 2020, Therapeutic innovation & regulatory science.

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors

Yow-Ming C Wang, D. Strauss, M. Matta, 2022, Clinical pharmacology and therapeutics.

A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications (BLAs) for the assessment of target and antidrug antibodies effects.

Yow-Ming C Wang, Shiew-Mei Huang, T. Thway, 2021, Bioanalysis.

Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors

Yow-Ming C Wang, I. Zineh, Shiew-Mei Huang, 2020, The AAPS Journal.

Digoxin Disposition in Elderly Humans with Hypochlorhydria

Yow-Ming C Wang, J. Caldwell, L. Robertson, 1994, Journal of clinical pharmacology.

Pharmacodynamics-Mediated Drug Disposition (PDMDD) and Precursor Pool Lifespan Model for Single Dose of Romiplostim in Healthy Subjects

Yow-Ming C Wang, J. Pérez-Ruixo, A. Chow, 2010, The AAPS Journal.

Investigation of the Pharmacokinetics of Romiplostim in Rodents with a Focus on the Clearance Mechanism

Yow-Ming C Wang, Yu‐Nien Sun, Bethlyn Sloey, 2011, Pharmaceutical Research.

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Neil Henderson, Rong Zeng, Renuka Pillutla, 2018, Bioanalysis.

Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium

Yow-Ming C Wang, B. Desilva, M. Rose, 2014, The AAPS Journal.

Drug Interactions for Growth Factors and Hormones

Yow-Ming C Wang, T. Kakkar, 2013 .

Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim in Animals

Yow-Ming C Wang, J. Pérez-Ruixo, A. Chow, 2013, Pharmaceutical Research.

Bioanalytical considerations in the comparability assessment of biotherapeutics.

Binodh DeSilva, Michael Moxness, Yow-Ming Wang, 2011, Bioanalysis.

Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

Yow-Ming C Wang, J. N. van den Anker, G. Burckart, 2019, Journal of clinical pharmacology.

Individualized Dosing of Therapeutic Monoclonal Antibodies—a Changing Treatment Paradigm?

Yow-Ming C Wang, D. Mould, L. Ruff, 2018, The AAPS Journal.

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

Yow-Ming C Wang, Y. Hon, L. Fang, 2016, The AAPS Journal.

A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays

Yow-Ming C Wang, L. Fang, Jie Wang, 2012, Pharmaceutical Research.

Biological Products for the Treatment of Psoriasis: Therapeutic Targets, Pharmacodynamics and Disease-Drug-Drug Interaction Implications

Yow-Ming C Wang, Jie Wang, H. Ahn, 2014, The AAPS Journal.

Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary

Yow-Ming C Wang, J. Polli, G. Lyman, 2022, Clinical pharmacology and therapeutics.

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (III) A Randomized Trial with Interferon Beta‐1a Products

Yow-Ming C Wang, D. Strauss, M. Matta, 2022, Clinical pharmacology and therapeutics.

An Experimental Design Strategy for Quantitating Complex Pharmacokinetic Models: Enterohepatic Circulation with Time-Varying Gallbladder Emptying as an Example

Yow-Ming C Wang, R. H. Reuning, 1992, Pharmaceutical Research.

Effect of Body Weight on Risk‐Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis

Yow-Ming C Wang, J. Florian, Jie Wang, 2019, Clinical pharmacology and therapeutics.

The Discovery of VX-745: A Novel and Selective p38α Kinase Inhibitor.

Huai Gao, Yow-Ming Wang, Yow-Ming C Wang, 2011, ACS medicinal chemistry letters.

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Eric Woolf, Akiko Ishii-Watabe, Naidong Weng, 2018, Bioanalysis.

Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics

S. J. Schrieber, Yow-Ming C Wang, B. Rosenzweig, 2022, Clinical pharmacology and therapeutics.

Population pharmacokinetic‐pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure

Yow-Ming C Wang, A. Chow, T. Vu, 2015, Journal of clinical pharmacology.

Advancing Innovations in Biosimilars

Yow-Ming C Wang, D. Strauss, 2022, Clinical pharmacology and therapeutics.

Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions.

Binodh DeSilva, Mark Ma, Theingi M. Thway, 2009, Journal of pharmaceutical and biomedical analysis.

Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins

Yow-Ming C Wang, Shiew-Mei Huang, Y. Hon, 2023, The AAPS Journal.

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Craig J. Thalhauser, Yow-Ming C Wang, A. Kierzek, 2019, Clinical and translational science.

Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors

Yow-Ming C Wang, I. Zineh, Shiew-Mei Huang, 2020, The AAPS Journal.

Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products

Yow-Ming C Wang, D. Tran, S. Seo, 2022, Clinical pharmacology and therapeutics.

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (II) A Randomized Trial with IL‐5 Antagonists

Yow-Ming C Wang, D. Strauss, M. Matta, 2022, Clinical pharmacology and therapeutics.

Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary

S. J. Schrieber, Yow-Ming C Wang, D. Strauss, 2022, Clinical pharmacology and therapeutics.

Exposure–Response Relationship of T‐DM1: Insight Into Dose Optimization for Patients With HER2‐Positive Metastatic Breast Cancer

S. J. Schrieber, Yow-Ming C Wang, P. Cortazar, 2014, Clinical pharmacology and therapeutics.

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

Yow-Ming C Wang, I. Zineh, R. Madabushi, 2020, Clinical pharmacology and therapeutics.

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Craig J. Thalhauser, Yow-Ming C Wang, A. Kierzek, 2019, Clinical and translational science.

Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary

Yow-Ming C Wang, J. Polli, G. Lyman, 2022, Clinical Pharmacology & Therapeutics.