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1. |
Record Nr. |
UNINA9911019143503321 |
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Autore |
Zhou Michael |
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Titolo |
Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou |
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Pubbl/distr/stampa |
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Hoboken, N.J., : Wiley, c2011 |
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ISBN |
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9786612889059 |
9780470922804 |
047092280X |
9781282889057 |
1282889052 |
9780470920671 |
047092067X |
9780470920664 |
0470920661 |
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Descrizione fisica |
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1 online resource (548 p.) |
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Disciplina |
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Soggetti |
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Medical laboratories - Quality control |
Biological laboratories - Quality control |
Pharmaceutical technology - Quality control |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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REGULATED BIOANALYTICAL LABORATORIES: Technical and Regulatory Aspects from Global Perspectives; CONTENTS; PREFACE; ACKNOWLEDGMENT; CONTRIBUTORS AND ADVISORS; 1 INTRODUCTION, OBJECTIVES, AND KEY REQUIREMENTS FOR GLP REGULATIONS; 1.1 INTRODUCTION; 1.1.1 Good Laboratory Practices; 1.1.2 Bioanalytical Laboratories-Bioanalysis; 1.1.3 Good Laboratory Practices Versus Bioanalytical Labs/Bioanalysis; 1.2 OBJECTIVES AND KEY REQUIREMENTS FOR GLP REGULATIONS; 1.3 FUNDAMENTAL UNDERSTANDING OF GLP REGULATIONS AND PRINCIPLES; 1.3.1 Elements of Good Laboratory Practices |
1.4 KEY ELEMENTS OF BIOANALYTICAL METHODS VALIDATION1.4.1 Reference Standards; 1.4.2 Method Development- |
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Chemical/Chromatographic Assay; 1.4.3 Calibration/Standard Curve; 1.4.4 Stability; 1.4.5 Reproducibility; 1.4.6 Robustness or Ruggedness; 1.5 BASIC PRINCIPLES OF BIOANALYTICAL METHOD VALIDATION AND ESTABLISHMENT; 1.5.1 Specific Recommendations for Method Validation; 1.5.2 Acceptance Criteria for Analytical Run; REFERENCES; 2 HISTORIC PERSPECTIVES OF GLP REGULATIONS, APPLICABILITY, AND RELATION TO OTHER REGULATIONS; 2.1 HISTORIC PERSPECTIVES OF GLP REGULATIONS; 2.1.1 Economic Assessment |
2.1.2 Environmental Impact2.2 APPLICABILITY AND RELATIONS TO OTHER REGULATIONS/ PRINCIPLES; 2.2.1 GLP, GCP, GMP, and Part 11; 2.2.2 General Terminologies and Definitions of GxPs (GLP, GCP, and cGMP); 2.3 COMPARISON OF FDA GLP, EPA GLP REGULATIONS, AND OECD GLP PRINCIPLES; 2.3.1 US and OECD GLP Similarity and Differences; 2.4 APPLICATIONS OF GLP TO MULTIPLE SITE STUDIES; 2.4.1 Roles and Responsibilities; 2.4.2 Performance of the Studies; 2.4.3 Applications of GLP to In Vitro Studies for Regulatory Submissions; 2.5 21 CFR PART 11 IN RELATION TO GLP PROGRAMS; 2.5.1 A New Risk-Based Approach |
2.5.2 Understanding Predicate Rule Requirements2.5.3 21 CFR Part 11 Best Practices; 2.5.4 Use of Electronic Signatures; 2.6 GLP, cGMP, AND ISO APPLICABILITIES, SIMILARITY, AND DIFFERENCES; 2.6.1 GLPs, cGMPs, ISO 17025:2005: How Do They Differ?; 2.6.2 GLPs Versus GMPs; 2.6.3 GLPs Versus ISO/IEC 17025:2005; 2.6.4 ISO Versus GLPs; 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 QUALITY SYSTEM |
3.1.1 Regulatory Inspection for GLP Quality System3.1.2 Good Laboratory Practice Inspections; 3.1.3 GLP Quality System Objectives; 3.2 GLOBAL GLP REGULATIONS AND PRINCIPLES; 3.2.1 General; 3.2.2 Responsibilities and Compliance; 3.2.3 Statement of Compliance in the Final Report; 3.2.4 Protocol Approval; 3.2.5 Assignment of Study Director; 3.2.6 Laboratory Qualification/Certification; 3.2.7 Authority Inspections; 3.2.8 Archiving Requirements; 3.3 IMPLEMENTATION OF GLP REGULATIONS AND OECD PRINCIPLES; 3.3.1 Planning (Master Schedule); 3.3.2 Personnel Organization; 3.3.3 Curriculum Vitae |
3.3.4 Rules of the Conducts of Studies |
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Sommario/riassunto |
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This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people |
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2. |
Record Nr. |
UNINA9910574862203321 |
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Titolo |
Geoinformatics and Data Analysis : Selected Proceedings of ICGDA 2022 / / edited by Salah Bourennane, Petr Kubicek |
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Pubbl/distr/stampa |
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Cham : , : Springer International Publishing : , : Imprint : Springer, , 2022 |
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ISBN |
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Edizione |
[1st ed. 2022.] |
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Descrizione fisica |
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1 online resource (206 pages) |
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Collana |
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Lecture Notes on Data Engineering and Communications Technologies, , 2367-4520 ; ; 143 |
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Disciplina |
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Soggetti |
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Engineering - Data processing |
Earth sciences |
Computational intelligence |
Data Engineering |
Earth Sciences |
Computational Intelligence |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Spatio-temporal Characteristics of Land-cover Changes in China During 2000-2019 -- Analyzing Geospatial Key Factors and Predicting Bike Activity in Hamburg -- Evaluation and Pattern Optimization of Ecological Space of Chongqing with Remote Sensing Data -- Research on Calculation Model of National Fragile State Based on Climate Vulnerability -- Daily Rainfall Analysis in Indonesia using ARIMA, Neural Network and LSTM -- Development of A Geoinformation Monitoring Module for The Khankalsky Geothermal Deposit in The Chechen Republic -- Mapping Fences in Xilingol Grassland Using High Spatiotemporal Resolution Remote Sensing Data -- Comparative Study on Remote Sensing Image Classifier of Jiulong River Basin -- OSM-GAN: Using Generative Adversarial Networks for Detecting Change in High-Resolution Spatial Images -- Analysis of Urban Sprawl and Growth Pattern Using Geospatial Technologies in Megacity, Bangkok, Thailand -- WEB-GIS for Transportation System of Oran City -- Construction |
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Method of City-levelGeographic Knowledge Graph Based on Geographic Entity -- Development of Remote Sensing Software Using a Boosted Tree Machine Learning Model Architecture for Professional and Citizen Science Applications -- Fast Construction of Vegetation Polygons Based on Object-oriented Method -- A/B Testing via Continuous Integration and Continuous Delivery -- An Automated Approach for Mapping between Software Requirements and Design Items: An Industrial Case from Turkey -- Code Comprehension for Read-Copy-Update Synchronization Contexts in C Code. |
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Sommario/riassunto |
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This book contains the proceedings of the 5th International Conference on Geoinformatics and Data Analysis (ICGDA 2022), held in January 21–23, Paris, France. Geoinformatics helps to support basic scientific inquiry as well as address the complex social and environmental challenges. It becomes very important technology to decision-makers across a wide range of disciplines such as computer science, information technology, software engineering, biogeography, geography, conservation, architecture, spatial analysis and reinforcement learning. The papers included in this proceeding share the latest research results and practical application examples on the methodologies and algorithms in the area of geoinformatics and data analysis, including software and information engineering, environmental geography and geographic information system, which makes the book a valuable reference for researchers, engineers and university students who are working in the field. |
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