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Regulated Bioanalysis: Fundamentals and Practice / edited by Mario L. Rocci Jr., Stephen Lowes

Contributor(s): Resource type: Ressourcentyp: Buch (Online)Book (Online)Language: English Series: AAPS Advances in the Pharmaceutical Sciences Series ; 26 | SpringerLink Bücher | Springer eBook Collection Biomedical and Life SciencesPublisher: Cham : Springer, 2017Description: Online-Ressource (XIII, 230 p. 22 illus., 17 illus. in color, online resource)ISBN:
  • 9783319548029
Subject(s): Additional physical formats: 9783319548005 | Druckausg.: 978-3-319-54800-5 | Printed edition: 9783319548005 LOC classification:
  • RS380 RS190-210
  • RS380
  • RS190-210
DOI: DOI: 10.1007/978-3-319-54802-9Online resources: Summary: This book is intended to cover the fundamental and practical aspects of regulated bioanalysis. The editors are seeking leading scientists in the field to participate in the development of this book, which we envision as a “one of a kind” contribution to our field. The book is intended for students in the pharmaceutical sciences, chemistry, biology and related scientific disciplines interested in bioanalysis, as well as working scientists new to the field of regulated bioanalysis. It will also serve as a primer for those experienced in the field. The depth of the book will seek to give its audience a solid foundation of knowledge in regulated bioanalysis which can be leveraged further with “hands on” experience. Understanding that bioanalytical global regulations evolve, the book is not intended as a deep-dive into regulatory language nuances but rather to be an educational text on conducting defendable and auditable science to support modern bioanalysis. Following an introduction to the topic by the editors, the book then covers “non-scientific” aspects of the topic area including the regulations governing this work, logistical and operational aspects of running a regulated bioanalytical laboratory and appropriate laboratory documentation. Next a description of the typically encountered types of bioanalytical samples, analytes and their attributes is provided. This information then sets the stage for a detailed discussion of the analytical platforms and assay types used in the regulated bioanalysis of small and large molecules. Also provided is a discussion of the different analytical phases of the bioanalytical process (i.e. method development including various strategies, pre-study validation and sample analysis)Summary: Introduction -- Understanding Bioanalysis Regulations -- Logistical and Operational Practice in the Regulated Bioanalysis Laboratory -- Regulated Bioanalysis: Documentation and Reports -- Historical Aspects and Key Concepts Related to its Use -- Fundamentals of LC-MS/MS for Regulated Bioanalysis -- Liquid Chromatography-Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory -- Development and maintenance of critical reagents for ligand binding assays to support regulatory-compliant bioanalysis -- Ligand Binding Assays in the Regulated Bioanalytical LaboratoryPPN: PPN: 165832823XPackage identifier: Produktsigel: ZDB-2-SBL
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