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

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

Affiliations

Valentina Shakhnovich

Children's Mercy Kansas City Kansas City Missouri USA

Bernd Meibohm

Department of Pharmaceutical Sciences University of Tennessee Health Science Center Memphis Tennessee USA

Amy Rosenberg

FDA Division of Biotechnology Review and Research III Office of Pharmaceutical Quality Office of Biotechnology Products CDER/FDA Silver Spring Maryland USA

Andrzej M. Kierzek

Certara Sheffield UK

Rachel Hasenkamp

Children's Mercy Kansas City Kansas City Missouri USA

Ryan S. Funk

Department of Pharmacy Practice The University of Kansas Kansas City Kansas USA

Craig J. Thalhauser

Quantitative Clinical Pharmacology Bristol‐Myers Squibb Princeton New Jersey USA

Piet H. van derGraaf

Certara Canterbury UK

Yow‐Ming C. Wang

Office of Clinical Pharmacology OTS/CDER/FDA Silver Spring Maryland USA

Lora Hamuro

Clinical Pharmacology & Pharmacometrics Bristol‐Myers Squibb Princeton New Jersey USA