Regulated bioanalytical laboratories: technical and regulatory aspects from global perspectives

INDICE: Preface. Acknowledgment. Contributors and Advisors. 1 Introduction,Objectives, and Key Requirements for GLP Regulations. 1.1 Introduction. 1.2 Objectives and Key Requirements for GLP Regulations. 1.3 Fundamental Understanding of GLP Regulations and Principles. 1.4 Key Elements of Bioanalytical Methods Validation. 1.5 Basic Principles of Bioanalytical Method Validation and Establishment. References. 2 Historic Perspectives of GLP Regulations, Applicability, and Relation to Other Regulations. 2.1 Historic Perspectives of GLP Regulations. 2.2 Applicability and Relations to Other Regulations/Principles. 2.3 Comparison of FDA GLP, EPA GLP Regulations, and OECD GLP Principles. 2.4 Applications of GLP to Multiple Site Studies. 2.5 21 CFR Part 11 in Relation to GLP Programs. 2.6 GLP, cGMP, and ISO Applicabilities, Similarity, and Differences.2.7 Good Clinical Practices and Good Clinical Laboratory Practices. 2.8 Gap and Current Initiatives on Regulating Laboratory Analysis in Support of Clinical Trials. References. 3 GLP Quality System and Implementation. 3.1 GLP QualitySystem. 3.2 Global GLP Regulations and Principles. 3.3 Implementation of GLP Regulations and OECD Principles. 3.4 Initiatives and Implementation of Bioanalytical Method Validation (Guidance for Industry BMVMay 2001). References. 4 Fundamental Elements and Structures for Regulated Bioanalytical Laboratories. 4.1 Introduction. 4.2 Fundamental Elements for Bioanalytical Laboratories. 4.3 Basic Requirements for GLP Infrastructure and Operations. 4.4 GxP Quality Systems References. 5 Technical and Regulatory Aspects of Bioanalytical Laboratories. 5.1 Fundamental Roles and Responsibilities of Bioanalytical Laboratories. 5.2 Qualification of Personnel, Instrumentation, and Analytical Procedures. 5.3Regulatory Compliance with GLP Within Bioanalytical Laboratories. 5.4 Joint-Effort from Industries and Regulatory Agencies. References. 6 Competitiveness of Bioanalytical LaboratoriesTechnical and Regulatory Perspectives. 6.1 Technical Aspect of Competitive Bioanalytical Laboratories. 6.2 Bioanalytical Processes and Techniques. 6.3 Enhancing Throughput and Efficiency in Bioanalysis. 6.4Technical Challenges and Issues on Regulated Bioanalysis. 6.5 Regulatory Aspects of Competitive Bioanalytical Laboratories. 6.6 Advanced/Competitive Bioanalytical Laboratories. 6.7 Applications and Advances in Biomarker and/or Ligand-Binding Assays within Bioanalytical Laboratories. References. 7 Sponsor and FDA/Regulatory Agency GLP Inspections and Study Audits. 7.1 GLP versus Biomedical Research Monitoring and Mutual Acceptance of Data for Global Regulations and Inspections. 7.2 Purposes and Benefits of Regulatory Inspections/Audits. 7.3Typical Inspections/Audits and Their Observations. 7.4 Regulatory Challenges for Bioanalytical Laboratories. 7.5 Handling and Facilitating GLP or GxP Audits/Inspections. Refe

• ISBN: 978-0-470-47659-8
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 552
• Fecha Publicación: 14/01/2011
• Nº Volúmenes: 1
• Idioma: Inglés