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Bioanalytical Aspects in Biological TherapeuticsDeepen your understanding of how critical data are generated from bioanalysisIn Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more.Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from:* A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics* Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies* Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays* In-depth examinations of critical reagents in bioanalysis* Regulatory expectations for bioanalytical method development, validation, and sample testingPerfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.
This issue of Surgical Pathology Clinics, guest edited by Mina L. Xu, will focus on Hematopathology. Topics include, but are not limited to, EBV associated Lymphoproliferative Disorders; Castleman lymphadenopathy; Early events in lymphoid neoplasms; Changes in cutaneous T-cell lymphoma diagnostic and prognostic considerations; Bone Pathology for Hematopathologists; Acute Leukemias of Ambiguous Lineage; Optimal minimal residual disease testing for AML; Defining boundaries between MDS, MPN and MDS/MPN; Updates in pediatric lymphomas; New entities in gastrointestinal lymphoproliferative disorders; Prognostication in Diffuse Large B-cell Lymphomas; Histiocytic Neoplasms commonly encountered by hematopathologists; and Challenges in the diagnosis of grey zone lymphomas.
Highlights the advances made in social network analysis and social web mining and its influence in the fields of computer science, information systems, sociology, organisation science discipline and much more. This collection of perspectives on developmental practice is useful for industrial practitioners as well as researchers and scholars.
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