Following intensive discussions, review, alignment of procedures and multiple surveys among their member companies, the European Bioanalysis Forum (EBF) is providing a recommendation on how to integrate incurred sample reproducibility (ISR) in the bioanalytical process. The recommendation aims to provide guidance throughout the lifecycle of a validated method, including the application of the method in study support. In its recommendation, the EBF considers both the internal discussions with EBF member companies, as well as the input provided in international meetings where ISR was discussed. The ultimate goal of the EBF recommendation is to ensure that bioanalytical methods can provide accurate and reproducible concentration data for pharmacokinetic and/or toxicokinetic evaluation, without any compromise, while safeguarding the optimal use of laboratory resources.
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Ligand-binding assays validated for quantitative bioanalysis of a novel antibody-drug conjugate in monkey serum and related application in a nonclinical study.
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Department of Immunoassay and Immunochemistry, Center for Drug Safety Evaluation and Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China; State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China; University of Chinese Academy of Sciences, Beijing 101408, China; Zhongshan Institute for Drug Discovery, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Zhongshan 528400, China. Electronic address:
Background: Antibody-drug conjugates (ADCs) are an emerging class of targeted therapeutics and are receiving growing attention in the pharmaceutical field. Here we aimed to validate two ligand binding assays for the quantitation of GQ1001, an ADC made of Trastuzumab site-specifically conjugated with DM1, in cynomolgus monkey serum, and then apply the validated assays to a nonclinical study.
Methods: The quantitative methods for conjugated GQ1001 and total GQ1001 were validated against regulatory guidance documents on bioanalytical method validation under a Good Laboratory Practice (GLP)-compliant environment.
A sensitive molecular probe exhibiting significant change in their photophysical and morphological behavior upon interaction with Fe ion.
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Department of Chemistry, Institute of Science, Banaras Hindu University, Varanasi 221005, UP, India. Electronic address:
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UMR CNRS 5629, laboratoire LCPO, Université de Bordeaux, Pessac, F-33600, France.
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School of Architecture and Civil Engineering, Xi'an University of Science and Technology, Xi'an, China.
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View Article and Find Full Text PDFBioanalytical Method Comparison Strategy for Clinical Anti-drug Antibody Immunoassays.
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Bioanalytical Sciences, Genentech, Inc, 1 DNA Way, South San Francisco, California, 94080, USA.
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