Immunogenicity and biomarkers: bioanalytical challenges and considerations

1,500 scientists lift the lid on reproducibility

(2016) Monya Baker   NATURE

Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development

(2016) Yanmei Lu et al.   Journal of Immunology Research

Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development

(2015) Meina Liang et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, immunogenicity, efficacy and safety

(2015) Zhenhua Xu et al.   JOURNAL OF CLINICAL PHARMACOLOGY

A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays

(2015) Jad Zoghbi et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity

(2014) Sheng Dai et al.   AAPS Journal

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   AAPS Journal

Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival

(2011) Paul Morgan et al.   DRUG DISCOVERY TODAY

Strategic Approach to Fit-for-Purpose Biomarkers in Drug Development

(2007) John A. Wagner   Annual Review of Pharmacology and Toxicology