A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment von Li, Zhe, Du, Xiulian, Wang, Yow-Ming C.

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Pharmacokinetics‐Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap von Li, Zhe, Du, Xiulian, Huang, Shiew Mei, Wang, Yow‐Ming C.

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Advancing Innovations in Biosimilars von Wang, Yow‐Ming, Strauss, David G.

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Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products von Vaidyanathan, Jayabharathi, Wang, Yow‐Ming C., Tran, Doanh, Seo, Shirley K.

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Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins von Wang, Yow‐Ming C., Ji, Ping, Hariharan, Sudharshan, Wang, Jie, Okusanya, Olanrewaju, AbuAsal, Bilal, Zhu, Hao, Madabushi, Rajanikanth, Huang, Shiew Mei, Zineh, Issam

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Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval von Strauss, David G., Wang, Yow‐Ming, Florian, Jeffry, Zineh, Issam

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Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective von Wang, Yow-Ming C., Wang, Jie, Hon, Yuen Yi, Zhou, Lin, Fang, Lanyan, Ahn, Hae Young

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Clinical pharmacology considerations for first‐in‐human clinical trials for enzyme replacement therapy von Stern, Sydney, Wang, Jie, Li, Ruo‐Jing, Hon, Yuen Yi, Weis, Shawna L., Wang, Yow‐Ming C., Schuck, Robert, Pacanowski, Michael

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Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective von Guinn, Daphne, Pressly, Michelle A., Liu, Zhichao, Ceresa, Carrie, Samuels, Sherbet, Wang, Yow‐Ming, Madabushi, Rajanikanth, Schmidt, Stephan, Fletcher, Elimika Pfuma

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Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments von Guinn, Daphne, Madabushi, Rajanikanth, Wang, Yow‐Ming, Zineh, Issam, Maxfield, Kimberly

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Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development von Li, Fang, Sun, Qin, Du, Shengnan, Florian, Jeffry, Wang, Yaning, Huang, Shiew Mei, Zineh, Issam, Wang, Yow‐Ming C.

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Evaluation of Truncated AUC as an Alternative Measure to Assess Pharmacokinetic Comparability in Bridging Biologic-Device Using Prefilled Syringes and Autoinjectors von Wen, Ya-Feng, Ji, Ping, Schrieber, Sarah J, Rathi, Sneha, McGuirt, Delaney, Liu, Jiang, Chen, Jianmeng, Wang, Yow-Ming, Doddapaneni, Suresh, Sahajwalla, Chandrahas

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Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism von Hon, Yuen Yi, Wang, Jie, Abodakpi, Henrietta, Balakrishnan, Anand, Pacanowski, Michael, Chakder, Sushanta, Smpokou, Patroula, Donohue, Kathleen, Wang, Yow‐Ming C.

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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies von 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.

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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 von 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.

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Effect of Body Weight on Risk‐Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis von Lee, Jee Eun, Wang, Jie, Florian, Jeffry, Wang, Yow‐Ming, Kettl, David, Marcus, Kendall, Woitach, Amy

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Changing the drug development and therapeutic paradigm with biologic drug combinations and bispecifics: How to choose between these two approaches? von Zheng, Songmao, Prell, Rodney, Sheng, Jennifer, Wang, Yow‐Ming, Hamuro, Lora

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Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics von 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

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Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary von 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.

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

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