Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

por Strauss, David G., Wang, Yow‐Ming, Florian, Jeffry, Zineh, Issam
Publicado 2022

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

por Zheng, Songmao, Prell, Rodney, Sheng, Jennifer, Wang, Yow‐Ming, Hamuro, Lora
Publicado 2022

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

por Strik, Anne S., Wang, Yow-Ming C., Ruff, Laura E., Yashar, William, Messmer, Bradley T., Mould, Diane R.
Publicado 2018

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

por Shakhnovich, Valentina, Meibohm, Bernd, Rosenberg, Amy, Kierzek, Andrzej M., Hasenkamp, Rachel, Funk, Ryan S., Thalhauser, Craig J., van der Graaf, Piet H., Wang, Yow‐Ming C., Hamuro, Lora
Publicado 2019

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

por Liu, Xiaomei I., Dallmann, André, Wang, Yow‐Ming, Green, Dionna J., Burnham, Janelle M., Chiang, Beatrice, Wu, Perry, Sheng, Mark, Lu, Kelley, van den Anker, John N., Burckart, Gilbert J.
Publicado 2019

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

por 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
Publicado 2022

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

por 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.
Publicado 2019