Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments - Marini, Joseph C.; Anderson, Michael; Cai, Xiao-Yan; Chappell, John; Coffey, Todd; Gouty, Dominique; Kasinath, Aparna; Koppenburg, Vera; Oldfield, Philip; Rebarchak, Shannon; Bowsher, Ronald R. (The AAPS journal, 2014)
Keywords: Biochemistry; Biological Assay - methods; Biological Assay - standards; Biomedical and Life Sciences; Biomedicine; Biosimilar Pharmaceuticals - pharmacokinetics; Biotechnology; Calibration; Drug Discovery; Ligands; Pharmacology/Toxicology; Pharmacy; Practice Guidelines as Topic; Radioligand Assay - methods; Radioligand Assay - standards; Reference Standards; Validation Studies as Topic; White Paper; biological product; ligand-binding assay; bioanalytical method validation; pharmacokinetic; biosimilar