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Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou
| Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou |
| Autore | Zhou Michael |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , [2011] |
| Descrizione fisica | 1 online resource (548 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical laboratories - Qualtiy control
Biological laboratories - Qualtiy control Pharmaceutical technology - Qualtiy control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-470-92280-X
1-282-88905-2 9786612889059 0-470-92067-X 0-470-92066-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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-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 |
| Record Nr. | UNINA-9910141049003321 |
Zhou Michael
|
||
| Hoboken, New Jersey : , : Wiley, , [2011] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou
| Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou |
| Autore | Zhou Michael |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , [2011] |
| Descrizione fisica | 1 online resource (548 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical laboratories - Qualtiy control
Biological laboratories - Qualtiy control Pharmaceutical technology - Qualtiy control |
| ISBN |
0-470-92280-X
1-282-88905-2 9786612889059 0-470-92067-X 0-470-92066-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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-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 |
| Record Nr. | UNINA-9910829916003321 |
|
Zhou Michael
|
||
| Hoboken, New Jersey : , : Wiley, , [2011] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou
| Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou |
| Autore | Zhou Michael |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (548 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical laboratories - Quality control
Biological laboratories - Quality control Pharmaceutical technology - Quality control |
| ISBN |
0-470-92280-X
1-282-88905-2 9786612889059 0-470-92067-X 0-470-92066-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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-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 |
| Record Nr. | UNINA-9910876788003321 |
|
Zhou Michael
|
||
| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||