OpenURL Connection Search

Select item for more details and to access through your institution.

A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment.
Published in:
Pharmaceutical Research, 2024, v. 41, n. 1, p. 13, doi. 10.1007/s11095-023-03627-5
By:
- Li, Zhe;
- Du, Xiulian;
- Wang, Yow-Ming C.
Publication type:
Article
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00819-0
By:
- Fletcher, Elimika Pfuma;
- Sahre, Martina;
- Hon, Yuen Yi;
- Balakrishnan, Anand;
- Zhou, Lin;
- Sun, Qin;
- Wang, Jie;
- Maxfield, Kimberly;
- Naik, Raajan;
- Huang, Shiew Mei;
- Wang, Yow-Ming C.
Publication type:
Article
Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors.
Published in:
AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0433-8
By:
- Hu, Ping;
- Wang, Jie;
- Florian, Jeffery;
- Shatzer, Katherine;
- Stevens, Alan M.;
- Gertz, Jacqueline;
- Ji, Ping;
- Huang, Shiew Mei;
- Zineh, Issam;
- Wang, Yow-Ming C.
Publication type:
Article
Individualized Dosing of Therapeutic Monoclonal Antibodies—a Changing Treatment Paradigm?
Published in:
AAPS Journal, 2018, v. 20, n. 6, p. 1, doi. 10.1208/s12248-018-0257-y
By:
- Strik, Anne S.;
- Wang, Yow-Ming C.;
- Ruff, Laura E.;
- Yashar, William;
- Messmer, Bradley T.;
- Mould, Diane R.
Publication type:
Article
Evaluating and Reporting the Immunogenicity Impacts for Biological Products-a Clinical Pharmacology Perspective.
Published in:
AAPS Journal, 2016, v. 18, n. 2, p. 395, doi. 10.1208/s12248-015-9857-y
By:
- Wang, Yow-Ming;
- Wang, Jie;
- Hon, Yuen;
- Zhou, Lin;
- Fang, Lanyan;
- Ahn, Hae
Publication type:
Article
Biological Products for the Treatment of Psoriasis: Therapeutic Targets, Pharmacodynamics and Disease-Drug-Drug Interaction Implications.
Published in:
AAPS Journal, 2014, v. 16, n. 5, p. 938, doi. 10.1208/s12248-014-9637-0
By:
- Wang, Jie;
- Wang, Yow-Ming;
- Ahn, Hae-Young
Publication type:
Article
Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium.
Published in:
AAPS Journal, 2014, v. 16, n. 3, p. 586, doi. 10.1208/s12248-014-9597-4
By:
- Bashaw, Edward D.;
- DeSilva, Binodh;
- Rose, Mark J.;
- Wang, Yow-Ming C.;
- Shukla, Chinmay
Publication type:
Article
Pharmacokinetics of Anti-hepcidin Monoclonal Antibody Ab 12B9m and Hepcidin in Cynomolgus Monkeys.
Published in:
AAPS Journal, 2010, v. 12, n. 4, p. 646, doi. 10.1208/s12248-010-9222-0
By:
- Xiao, Jim;
- Krzyzanski, Wojciech;
- Wang, Yow-Ming;
- Li, Hongyan;
- Rose, Mark;
- Ma, Mark;
- Wu, Yuling;
- Hinkle, Beth;
- Perez-Ruixo, Juan
Publication type:
Article
Pharmacodynamics-Mediated Drug Disposition (PDMDD) and Precursor Pool Lifespan Model for Single Dose of Romiplostim in Healthy Subjects.
Published in:
AAPS Journal, 2010, v. 12, n. 4, p. 729, doi. 10.1208/s12248-010-9234-9
By:
- Wang, Yow-Ming;
- Krzyzanski, Wojciech;
- Doshi, Sameer;
- Xiao, Jim;
- Pérez-Ruixo, Juan;
- Chow, Andrew
Publication type:
Article
Romiplostim dose-response in patients with myelodysplastic syndromes.
Published in:
British Journal of Clinical Pharmacology, 2013, v. 75, n. 6, p. 1445, doi. 10.1111/bcp.12041
By:
- Perez Ruixo, Juan Jose;
- Doshi, Sameer;
- Wang, Yow‐Ming C.;
- Mould, Diane R.
Publication type:
Article
Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report.
Published in:
AAPS Open, 2022, v. 8, n. 1, p. 1, doi. 10.1186/s41120-021-00050-1
By:
- Mathews, Joel;
- Amaravadi, Lakshmi;
- Eck, Steven;
- Stevenson, Lauren;
- Wang, Yow-Ming C.;
- Devanarayan, Viswanath;
- Allinson, John;
- Lundsten, Kelly;
- Gunsior, Michele;
- Ni, Yan G.;
- Pepin, Marc-Olivier;
- Gagnon, Audrey;
- Sheldon, Curtis;
- Trampont, Paul C.;
- Litwin, Virginia
Publication type:
Article
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 3, p. 440, doi. 10.1002/cpt.3178
By:
- Wang, Yow‐Ming C.;
- Ji, Ping;
- Hariharan, Sudharshan;
- Wang, Jie;
- Okusanya, Olanrewaju;
- AbuAsal, Bilal;
- Zhu, Hao;
- Madabushi, Rajanikanth;
- Huang, Shiew Mei;
- Zineh, Issam
Publication type:
Article
Pharmacokinetics‐Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 3, p. 404, doi. 10.1002/cpt.3145
By:
- Li, Zhe;
- Du, Xiulian;
- Huang, Shiew Mei;
- Wang, Yow‐Ming C.
Publication type:
Article
Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 3, p. 412, doi. 10.1002/cpt.3133
By:
- Ait‐Oudhia, Sihem;
- Wang, Yow‐Ming;
- Dosne, Anne‐Gaelle;
- Roy, Amit;
- Jin, Jin Y.;
- Shen, Jun;
- Kagan, Leonid;
- Musuamba, Flora T.;
- Zhang, Lucia;
- Kijima, Shinichi;
- Gastonguay, Marc R.;
- Ouellet, Daniele
Publication type:
Article
Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 5, p. 1030, doi. 10.1002/cpt.2795
By:
- Florian, Jeffry;
- Sun, Qin;
- Schrieber, Sarah J.;
- White, Richard;
- Shubow, Sophie;
- Johnson‐Williams, Bernadette E.;
- Sheikhy, Morasa;
- Harrison, Nicholas R.;
- Parker, Valerie J.;
- Wang, Yow‐Ming;
- Strauss, David G.
Publication type:
Article
Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 4, p. 794, doi. 10.1002/cpt.2731
By:
- Vaidyanathan, Jayabharathi;
- Wang, Yow‐Ming C.;
- Tran, Doanh;
- Seo, Shirley K.
Publication type:
Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (III) A Randomized Trial with Interferon Beta‐1a Products.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 2, p. 339, doi. 10.1002/cpt.2784
By:
- Florian, Jeffry;
- Gershuny, Victoria;
- Sun, Qin;
- Schrieber, Sarah J.;
- Matta, Murali K.;
- Hazel, Anthony;
- Sheikhy, Morasa;
- Weaver, James L.;
- Hyland, Paula L.;
- Hsiao, Cheng‐Hui;
- Vegesna, Giri;
- DePalma, Ryan;
- Shah, Aanchal;
- Prentice, Kristin;
- Sanabria, Carlos;
- Wang, Yow‐Ming;
- Strauss, David G.
Publication type:
Article
Advancing Innovations in Biosimilars.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 11, doi. 10.1002/cpt.2782
By:
- Wang, Yow‐Ming;
- Strauss, David G.
Publication type:
Article
Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 37, doi. 10.1002/cpt.2765
By:
- Shubow, Sophie;
- Sun, Qin;
- Nguyen Phan, Ai Len;
- Hammell, Dana C.;
- Kane, Maureen;
- Lyman, Gary H.;
- Gibofsky, Allan;
- Lichtenstein, Gary R.;
- Bloomgarden, Zachary;
- Cross, Raymond K.;
- Yim, Sarah;
- Polli, James E.;
- Wang, Yow‐Ming
Publication type:
Article
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 98, doi. 10.1002/cpt.2778
By:
- Hyland, Paula L.;
- Chekka, Lakshmi Manasa S.;
- Samarth, Deepti P.;
- Rosenzweig, Barry A.;
- Decker, Erica;
- Mohamed, Esraa G.;
- Guo, Yan;
- Matta, Murali K.;
- Sun, Qin;
- Wheeler, William;
- Sanabria, Carlos;
- Weaver, James L.;
- Schrieber, Sarah J.;
- Florian, Jeffry;
- Wang, Yow‐Ming;
- Strauss, David G.
Publication type:
Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 71, doi. 10.1002/cpt.2769
By:
- Sheikhy, Morasa;
- Schrieber, Sarah J.;
- Sun, Qin;
- Gershuny, Victoria;
- Matta, Murali K.;
- Bai, Jane P.F.;
- Du, Xiulian;
- Vegesna, Giri;
- Shah, Aanchal;
- Prentice, Kristin;
- Nalepinski, Colleen;
- Zineh, Issam;
- Wang, Yow‐Ming;
- Strauss, David G.;
- Florian, Jeffry
Publication type:
Article
Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 55, doi. 10.1002/cpt.2761
By:
- Strauss, David G.;
- Wang, Yow‐Ming;
- Florian, Jeffry;
- Zineh, Issam
Publication type:
Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (II) A Randomized Trial with IL‐5 Antagonists.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 80, doi. 10.1002/cpt.2760
By:
- Gershuny, Victoria;
- Sun, Qin;
- Schrieber, Sarah J.;
- Matta, Murali K.;
- Weaver, James L.;
- Ji, Ping;
- Sheikhy, Morasa;
- Hsiao, Cheng‐Hui;
- Vegesna, Giri;
- Shah, Aanchal;
- Prentice, Kristin;
- Deering, Jennifer;
- Wang, Yow‐Ming;
- Strauss, David G.;
- Florian, Jeffry
Publication type:
Article
Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 62, doi. 10.1002/cpt.2722
By:
- Li, Fang;
- Sun, Qin;
- Du, Shengnan;
- Florian, Jeffry;
- Wang, Yaning;
- Huang, Shiew Mei;
- Zineh, Issam;
- Wang, Yow‐Ming C.
Publication type:
Article
Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 3, p. 697, doi. 10.1002/cpt.2038
By:
- Guinn, Daphne;
- Madabushi, Rajanikanth;
- Wang, Yow‐Ming;
- Zineh, Issam;
- Maxfield, Kimberly
Publication type:
Article
Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 1, p. 40, doi. 10.1002/cpt.1653
By:
- Li, Junyi;
- Florian, Jeffry;
- Campbell, Elizabeth;
- Schrieber, Sarah J.;
- Bai, Jane P.F.;
- Weaver, James L.;
- Hyland, Paula L.;
- Thway, Theingi M.;
- Matta, Murali K.;
- Lankapalli, Rachana H.;
- Narayanasamy, Suresh;
- Dancy, Jimena;
- Zusterzeel, Robbert;
- Tyson, Jessica Y.;
- Prentice, Kristin W.;
- Jackson, Kathryn C.;
- Patel, Vikram;
- Rouse, Rodney L.;
- Wang, Yow‐Ming C.;
- Strauss, David G.
Publication type:
Article
Effect of Body Weight on Risk‐Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 78, doi. 10.1002/cpt.1478
By:
- Lee, Jee Eun;
- Wang, Jie;
- Florian, Jeffry;
- Wang, Yow‐Ming;
- Kettl, David;
- Marcus, Kendall;
- Woitach, Amy
Publication type:
Article
Considerations for Biologic Product Drug–Drug Interactions: A Regulatory Perspective.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 6, p. 1332, doi. 10.1002/cpt.1366
By:
- Schrieber, Sarah J.;
- Pfuma‐Fletcher, Elimika;
- Wang, Yow‐Ming C.;
- Sagoo, Sharonjit;
- Madabushi, Rajanikanth;
- Huang, Shiew‐Mei;
- Zineh, Issam;
- Wang, Xiaofei
Publication type:
Article
Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure.
Published in:
Journal of Clinical Pharmacology, 2015, v. 55, n. 11, p. 1236, doi. 10.1002/jcph.538
By:
- Vu, Thuy;
- Ma, Peiming;
- Xiao, Jim J.;
- Wang, Yow‐Ming C.;
- Malik, Fady I.;
- Chow, Andrew T.
Publication type:
Article
Digoxin Disposition in Elderly Humans with Hypochlorhydria.
Published in:
1994
By:
- Hui, James;
- Geraets, Douglas R.;
- Chandrasekaran, Appavu;
- Wang, Yow-Ming C.;
- Caldwell, James H.;
- Robertson, Larry W.;
- Donnerberg, Roy L.;
- Reuning, Richard H.
Publication type:
Other
Evaluation of Truncated AUC as an Alternative Measure to Assess Pharmacokinetic Comparability in Bridging Biologic–Device Using Prefilled Syringes and Autoinjectors.
Published in:
Journal of Clinical Pharmacology, 2023, v. 63, n. 12, p. 1417, doi. 10.1002/jcph.2322
By:
- Wen, Ya‐Feng;
- Ji, Ping;
- Schrieber, Sarah J.;
- Rathi, Sneha;
- McGuirt, Delaney;
- Liu, Jiang;
- Chen, Jianmeng;
- Wang, Yow‐Ming;
- Doddapaneni, Suresh;
- Sahajwalla, Chandrahas
Publication type:
Article
Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective.
Published in:
Journal of Clinical Pharmacology, 2023, v. 63, n. 3, p. 273, doi. 10.1002/jcph.2177
By:
- Guinn, Daphne;
- Pressly, Michelle A.;
- Liu, Zhichao;
- Ceresa, Carrie;
- Samuels, Sherbet;
- Wang, Yow‐Ming;
- Madabushi, Rajanikanth;
- Schmidt, Stephan;
- Fletcher, Elimika Pfuma
Publication type:
Article
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.
Published in:
Journal of Clinical Pharmacology, 2019, v. 59, n. 8, p. 1130, doi. 10.1002/jcph.1406
By:
- Liu, Xiaomei I.;
- Dallmann, André;
- Wang, Yow‐Ming;
- Green, Dionna J.;
- Burnham, Janelle M.;
- Chiang, Beatrice;
- Wu, Perry;
- Sheng, Mark;
- Lu, Kelley;
- Anker, John N.;
- Burckart, Gilbert J.
Publication type:
Article
On placental and lactational transfer of IgG‐based therapeutic proteins – Current understanding and knowledge gaps from a clinical pharmacology perspective.
Published in:
CTS: Clinical & Translational Science, 2024, v. 17, n. 10, p. 1, doi. 10.1111/cts.70049
By:
- Guinn, Daphne;
- Kratz, Katherine;
- Baisden, Kristie;
- Ridge, Sarah;
- McClymont, Sonaly;
- Fletcher, Elimika Pfuma;
- Johnson, Tamara;
- Wang, Yow‐Ming
Publication type:
Article
Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism.
Published in:
CTS: Clinical & Translational Science, 2023, v. 16, n. 12, p. 2438, doi. 10.1111/cts.13652
By:
- Hon, Yuen Yi;
- Wang, Jie;
- Abodakpi, Henrietta;
- Balakrishnan, Anand;
- Pacanowski, Michael;
- Chakder, Sushanta;
- Smpokou, Patroula;
- Donohue, Kathleen;
- Wang, Yow‐Ming C.
Publication type:
Article
Changing the drug development and therapeutic paradigm with biologic drug combinations and bispecifics: How to choose between these two approaches?
Published in:
CTS: Clinical & Translational Science, 2022, v. 15, n. 9, p. 2096, doi. 10.1111/cts.13345
By:
- Zheng, Songmao;
- Prell, Rodney;
- Sheng, Jennifer;
- Wang, Yow‐Ming;
- Hamuro, Lora
Publication type:
Article
Immunogenicity in Clinical Practice and Drug Development: When is it Significant?
Published in:
CTS: Clinical & Translational Science, 2020, v. 13, n. 2, p. 219, doi. 10.1111/cts.12717
By:
- Shakhnovich, Valentina;
- Meibohm, Bernd;
- Rosenberg, Amy;
- Kierzek, Andrzej M.;
- Hasenkamp, Rachel;
- Funk, Ryan S.;
- Thalhauser, Craig J.;
- Graaf, Piet H.;
- Wang, Yow‐Ming C.;
- Hamuro, Lora
Publication type:
Article
Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with lower risk myelodysplastic syndromes.
Published in:
Cancer (0008543X), 2011, v. 117, n. 5, p. 992, doi. 10.1002/cncr.25545
By:
- Sekeres, Mikkael A.;
- Kantarjian, Hagop;
- Fenaux, Pierre;
- Becker, Pamela;
- Boruchov, Adam;
- Guerci-Bresler, Agnes;
- Kuolung Hu;
- Franklin, Janet;
- Wang, Yow-Ming C.;
- Berger, Dietmar
Publication type:
Article
Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim in Animals.
Published in:
Pharmaceutical Research, 2013, v. 30, n. 3, p. 655, doi. 10.1007/s11095-012-0894-2
By:
- Krzyzanski, Wojciech;
- Sutjandra, Liviawati;
- Perez-Ruixo, Juan;
- Sloey, Bethlyn;
- Chow, Andrew;
- Wang, Yow-Ming
Publication type:
Article
A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays.
Published in:
Pharmaceutical Research, 2012, v. 29, n. 12, p. 3384, doi. 10.1007/s11095-012-0833-2
By:
- Wang, Yow-Ming;
- Fang, Lanyan;
- Zhou, Lin;
- Wang, Jie;
- Ahn, Hae-Young
Publication type:
Article
Investigation of the Pharmacokinetics of Romiplostim in Rodents with a Focus on the Clearance Mechanism.
Published in:
Pharmaceutical Research, 2011, v. 28, n. 8, p. 1931, doi. 10.1007/s11095-011-0420-y
By:
- Wang, Yow-Ming;
- Sloey, Bethlyn;
- Wong, Teresa;
- Khandelwal, Prerna;
- Melara, Rebeca;
- Sun, Yu-Nien
Publication type:
Article

Found: 41