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Informationen zum Autor Michael Zhou, PhD, is Director of Bioanalytical Chemistry at Synta Pharmaceuticals Corporation and a highly regarded expert on analytical/bioanalytical operations, regulatory compliance, including Good Laboratory Practice (GLP), cGMP, GCP regulations, and ICH, GCLP, BMV guidelines. Dr. Zhou has given numerous presentations and workshops / short courses on the topics at national and international conferences and has authored over fifty research articles and two book chapters on analytical/bioanalytical chemistry Klappentext Everything staff members in bioanalytical/analytical laboratories and quality assurance unit need to know about technical expertise and regulatory compliance This book provides much-needed practical information on how to generate and review data for regulatory consideration in the biotech, pharmaceutical, and life science industries. It explains in detail how to develop and implement effective strategies for meeting technical challenges, Good Laboratory Practice (GLP) and GxP requirements from global perspectives, with an emphasis on tools and techniques for ensuring the quality and integrity of study data. Readers will gain invaluable insight into the entire hardware and software qualification process as well as people qualification, learn how to get through laboratory audits and inspections with ease, and acquire a thorough understanding of all regulatory issues relevant to their work. Coverage includes: International standards and regulations from the US FDA, USP, ICH, OECD, WHO, ISO, EMEA, and EU Requirements, objectives, and implementation of GLP and GxP quality systems Facility and personnel infrastructure and qualification Techniques for modern bioanalytical / analytical sample preparation and essential concepts in extraction chemistry and separation mechanisms Specific strategies for the efficient use of laboratory automation with high throughput Instrumental analysis for hyphenated techniques such as LC-MS/MS and so on Important laboratory applications of Ligand Binding Assays (LBAs) andbiomarker assays A must-have for scientists, graduate students, and quality assurance managers in bioanalytical laboratories, Regulated Bioanalytical Laboratories is also an essential reference for anyone interested in the overall technical know-how, regulatory, and quality assurance trends in the field. Zusammenfassung Developing and implementing strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process, is the topic of this book. It includes guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Inhaltsverzeichnis Preface xiii Acknowledgment xvii Contributors and Advisors xix 1 Introduction, Objectives, and Key Requirements for GLP Regulations 1 1.1 Introduction 1 1.1.1 Good Laboratory Practices 1 1.1.2 Bioanalytical Laboratories-Bioanalysis 4 1.1.3 Good Laboratory Practices Versus Bioanalytical Labs/ Bioanalysis 7 1.2 Objectives and Key Requirements for GLP Regulations 8 1.3 Fundamental Understanding of GLP Regulations and Principles 10 1.3.1 Elements of Good Laboratory Practices 11 1.4 Key Elements of Bioanalytical Methods Validation 16 1.4.1 Reference Standards 19 1.4.2 Method Development-Chemical/Chromatographic Assay 20 1.4.3 Calibration/Standard Curve 21 1.4.4 Stability 21 1.4.5 Reproducibility 23 1.4.6 Robustness or Ruggedness 23 1.5 Basic Principles of Bioanalytical Method Validation and Establishment 23 1.5.1 Specific Recommendations for Method Validation 24 1.5.2 Acceptance Criteria for Analytical Run 29 References 33 2 Historic Perspective...
