LEADER 00846nam a2200253 i 4500 001 991002692569707536 005 20020503172353.0 008 990302s1976 it ||| | ita 035 $ab1040112x-39ule_inst 035 $aEXGIL108205$9ExL 040 $aDip.to Filol. Ling. e Lett.$bita 082 0 $a412 100 1 $aZamboni, Alberto$0156733 245 12$aL'etimologia /$cAlberto Zamboni 260 $aBologna :$bZanichelli,$cstampa 1976 300 $aVI, 218 p. ;$c19 cm. 490 0 $aBiblioteca linguistica 650 4$aEtimologia 907 $a.b1040112x$b21-02-17$c27-06-02 912 $a991002692569707536 945 $aLE008 L.L.I.D A III 44$g1$i2008000456481$lle008$o-$pE0.00$q-$rl$s- $t0$u0$v0$w0$x0$y.i10468201$z27-06-02 996 $aEtimologia$917797 997 $aUNISALENTO 998 $ale008$b01-01-99$cm$da $e-$fita$git $h2$i1 LEADER 05584nam 2200709Ia 450 001 9911019143503321 005 20200520144314.0 010 $a9786612889059 010 $a9780470922804 010 $a047092280X 010 $a9781282889057 010 $a1282889052 010 $a9780470920671 010 $a047092067X 010 $a9780470920664 010 $a0470920661 035 $a(CKB)2670000000066541 035 $a(EBL)698838 035 $a(OCoLC)689994989 035 $a(SSID)ssj0000441633 035 $a(PQKBManifestationID)11284898 035 $a(PQKBTitleCode)TC0000441633 035 $a(PQKBWorkID)10406906 035 $a(PQKB)11418978 035 $a(MiAaPQ)EBC698838 035 $a(Perlego)1010490 035 $a(EXLCZ)992670000000066541 100 $a20100607d2011 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aRegulated bioanalytical laboratories $etechnical and regulatory aspects from global perspectives /$fMichael Zhou 210 $aHoboken, N.J. $cWiley$dc2011 215 $a1 online resource (548 p.) 300 $aDescription based upon print version of record. 311 08$a9780470476598 311 08$a0470476591 320 $aIncludes bibliographical references and index. 327 $aREGULATED 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 327 $a1.4 KEY ELEMENTS OF BIOANALYTICAL METHODS VALIDATION1.4.1 Reference Standards; 1.4.2 Method Development-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 327 $a2.1.2 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 327 $a2.5.2 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 327 $a3.1.1 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 327 $a3.3.4 Rules of the Conducts of Studies 330 $aThis 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 606 $aMedical laboratories$xQuality control 606 $aBiological laboratories$xQuality control 606 $aPharmaceutical technology$xQuality control 615 0$aMedical laboratories$xQuality control. 615 0$aBiological laboratories$xQuality control. 615 0$aPharmaceutical technology$xQuality control. 676 $a610.28/4 700 $aZhou$b Michael$01688702 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911019143503321 996 $aRegulated bioanalytical laboratories$94063169 997 $aUNINA LEADER 04786nam 22006735 450 001 9910574862203321 005 20251229071938.0 010 $a3-031-08017-3 024 7 $a10.1007/978-3-031-08017-3 035 $a(MiAaPQ)EBC7015844 035 $a(Au-PeEL)EBL7015844 035 $a(CKB)23736964200041 035 $aEBL7015844 035 $a(AU-PeEL)EBL7015844 035 $a(PPN)267815433 035 $a(BIP)84548790 035 $a(BIP)84151254 035 $a(DE-He213)978-3-031-08017-3 035 $a(EXLCZ)9923736964200041 100 $a20220609d2022 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aGeoinformatics and Data Analysis $eSelected Proceedings of ICGDA 2022 /$fedited by Salah Bourennane, Petr Kubicek 205 $a1st ed. 2022. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2022. 215 $a1 online resource (206 pages) 225 1 $aLecture Notes on Data Engineering and Communications Technologies,$x2367-4520 ;$v143 300 $aDescription based upon print version of record. 311 08$aPrint version: Bourennane, Salah Geoinformatics and Data Analysis Cham : Springer International Publishing AG,c2022 9783031080166 320 $aIncludes bibliographical references and index. 327 $aSpatio-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 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. 330 $aThis book contains the proceedings of the 5th International Conference on Geoinformatics and Data Analysis (ICGDA 2022), held in January 21?23, Paris, France. Geoinformatics helps to support basic scientific inquiry as well as address the complex social and environmental challenges. It becomes very important technology to decision-makers across a wide range of disciplines such as computer science, information technology, software engineering, biogeography, geography, conservation, architecture, spatial analysis and reinforcement learning. The papers included in this proceeding share the latest research results and practical application examples on the methodologies and algorithms in the area of geoinformatics and data analysis, including software and information engineering, environmental geography and geographic information system, which makes the book a valuable reference for researchers, engineers and university students who are working in the field. 410 0$aLecture Notes on Data Engineering and Communications Technologies,$x2367-4520 ;$v143 606 $aEngineering$xData processing 606 $aEarth sciences 606 $aComputational intelligence 606 $aData Engineering 606 $aEarth Sciences 606 $aComputational Intelligence 615 0$aEngineering$xData processing. 615 0$aEarth sciences. 615 0$aComputational intelligence. 615 14$aData Engineering. 615 24$aEarth Sciences. 615 24$aComputational Intelligence. 676 $a006.312 676 $a910.285 702 $aBourennane$b Salah 702 $aKubicek$b Petr 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910574862203321 996 $aGeoinformatics and Data Analysis$92880512 997 $aUNINA