دانلود کتاب Handbook of Analytical Quality by Design

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a954473a_Cover(full permission)
Title-page_2021_Handbook-of-Analytical-Quality-by-Design
Handbook of Analytical Quality by Design
Copyright_2021_Handbook-of-Analytical-Quality-by-Design
Copyright
Contents_2021_Handbook-of-Analytical-Quality-by-Design
Contents
List-of-Contributors_2021_Handbook-of-Analytical-Quality-by-Design
List of Contributors
About-the-Editors_2021_Handbook-of-Analytical-Quality-by-Design
About the Editors
Preface_2021_Handbook-of-Analytical-Quality-by-Design
Preface
Chapter-1---Introduction-to-analytical-qu_2021_Handbook-of-Analytical-Qualit
1 Introduction to analytical quality by design
1.1 Introduction
1.2 Analytical quality by design principles and fundamentals
1.3 Basic analytical quality by design terminology
1.4 Analytical quality by design strategic principles and implementation steps
1.5 Analytical quality by design in life-cycle management
1.6 Regulatory standpoints on analytical quality by design
1.7 Potential applications of analytical quality by design in analytical settings
1.7.1 Analytical method development
1.7.2 Bioanalytical method development
1.7.3 Identification of impurities and degradation products
1.7.4 Nondestructive pharmaceutical analysis
1.8 Conclusion
References
Chapter-2---Analytical-quality-by-design-for-spe_2021_Handbook-of-Analytical
2 Analytical quality by design for spectrophotometric method development
2.1 Introduction
2.2 Why is analytical quality-by-design required?
2.3 Steps followed in analytical quality-by-design
2.4 Method for risk assessment
2.4.1 Design of experiments
2.5 Impact assessment of the critical method parameters on the performance
2.6 Defining method control strategies and method validation
2.7 Ultraviolet spectroscopy
2.8 Spectroflourimetry
2.9 Conclusion
References
Chapter-3---Analytical-quality-by-design-for-gas_2021_Handbook-of-Analytical
3 Analytical quality by design for gas chromatographic method development
3.1 Introduction
3.2 Quality by design principle
3.3 Need for quality by design in gas chromatography process development
3.4 Methodological aspects
3.5 Implementation of quality by design in gas chromatography
3.6 Statistical tools supporting gas chromatography-quality by design
3.7 Experimental design
3.7.1 Screening
3.7.2 Optimization
3.7.3 Selection of design of experiment tools
3.7.4 Method operable design and surface plot
3.7.5 Model validation and verification
3.8 Areas explored
3.8.1 Qualitative and quantitative analysis of phytoconstituents
3.8.2 Quantitation of residual solvents
3.9 Method control strategy
3.10 Validation and post method consideration
3.11 Implementation in current practice
3.12 Regulatory consideration for current and future
3.13 Conclusion
3.14 Conflicts of interest
References
Chapter-4---Analytical-quality-by-design-for-s_2021_Handbook-of-Analytical-Q
4 Analytical quality by design for size-exclusion chromatography
4.1 Introduction
4.2 Application of various analytical quality by designs in size-exclusion chromatography
4.2.1 Box–Behnken design
4.2.2 Central composite design
4.2.3 D-optimal design
4.2.4 Full factorial design
4.2.5 Miscellaneous
4.3 Conclusion and future perspectives
Conflicts of interest
References
Chapter-5---Analytical-quality-by-design-for-liq_2021_Handbook-of-Analytical
5 Analytical quality by design for liquid chromatographic method development
5.1 Introduction
5.2 Analytical quality by design overview
5.2.1 Selection of method variables and response variables
5.2.2 Optimization of the method factors using chemometric tools
5.2.3 Optimum criteria demarcation in the design space
5.3 Analytical quality by design application to liquid chromatographic methods
5.3.1 High-performance liquid chromatography
5.3.2 Ultra-performance liquid chromatography
5.3.3 Ultra-fast liquid chromatography
5.3.4 Liquid chromatography-mass spectroscopy
5.3.5 High-performance thin-layer chromatography
5.4 Conclusion
References
Chapter-6---Analytical-quality-by-design-for-high-p_2021_Handbook-of-Analyti
6 Analytical quality by design for high-performance thin-layer chromatography method development
6.1 Introduction
6.2 Principle of quality by design
6.3 Need for quality by design in high-performance thin-layer chromatography method development
6.4 Methodological aspects
6.5 Implementation of quality by design in high-performance thin-layer chromatography
6.6 Statistical tools supporting high-performance thin-layer chromatography quality by design experimental design
6.6.1 Analytical target profile
6.6.2 Critical quality attribute
6.6.3 Risk assessment
6.6.4 Design space
6.6.5 Design of experiment
6.6.5.1 Screening
6.6.5.2 Optimization
6.6.5.3 Surface plot
6.6.5.4 Model validation
6.7 Method control strategy
6.8 Validation and postmethod consideration
6.9 Implementation in current practice
6.10 Regulatory consideration for the current and future scenario
6.11 Conclusion
Conflicts of interest
References
Chapter-7---Analytical-quality-by-design-for-_2021_Handbook-of-Analytical-Qu
7 Analytical quality by design for capillary electrophoresis
7.1 Introduction
7.2 Key aspects of analytical quality by design
7.3 Quality target product profile and critical quality attributes
7.4 Traditional validation versus analytical quality by design
7.4.1 Assessment of critical method parameters by quality risk assessment
7.5 Design of experiment
7.6 Understanding design space
7.7 Robustness and control strategy
7.8 Applications of capillary electrophoresis in the pharmaceutical, food, biomedical, or other fields
7.8.1 Pharmaceuticals
7.8.2 Proteins, peptides, and amino acids
7.8.3 Carbohydrates
7.8.4 Bioanalysis
7.8.5 Food analysis
7.8.6 Environmental and forensic analysis
7.8.7 Bioaffinity
References
Chapter-8---Quality-by-design-based-development-_2021_Handbook-of-Analytical
8 Quality by design–based development of vibrational spectroscopy methods
8.1 Introduction
8.2 Quality by design tools
8.2.1 Critical quality attributes tool
8.2.2 Target product profile tool
8.2.3 Risk assessment
8.2.4 Design space
8.2.5 Control strategy
8.3 Vibrational spectroscopy analysis with the quality by design approach
8.4 Applications of quality by design in development of vibrational approach
8.4.1 High-performance liquid chromatography for assay and impurity profile
8.4.2 Karl Fischer titration for water determination
8.4.3 Quantitative color measurement
8.4.4 Chemical identification by vibrational spectroscopy
8.4.5 Dissolution methods
8.4.6 API and excipients identification
8.4.7 Polymorphism
References
Chapter-9---Quality-by-design-based-development-_2021_Handbook-of-Analytical
9 Quality by design-based development of nondestructive analytical techniques
9.1 Introduction
9.2 Process analytical technology
9.3 Chemometric tools employed in quality by design
9.3.1 Principal component analysis
9.3.2 Partial least squares regression
9.4 Implementation of quality by design-based nondestructive analytical techniques in pharmaceutical unit operations
9.4.1 Blending
9.4.2 Granulation
9.4.3 Drying
9.4.4 Coating
9.4.5 Freeze drying
9.4.6 Miscellaneous pharmaceutical processes
9.5 Conclusion and future outlook
References
Chapter-10---Risk-assessment-and-design-space-con_2021_Handbook-of-Analytica
10 Risk assessment and design space consideration in analytical quality by design
10.1 Introduction to analytical quality by design
10.2 Rewards of analytical quality-by-design approach to analytical methods
10.3 Regulatory perspective of analytical quality by design
10.4 Risk assessment in analytical method
10.5 Risk assessment in HPLC method development
10.5.1 Qualitative variables
10.5.2 Quantitative variables
10.6 Example: risk assessment in analytical quality by design–based HPLC method for etofenamate
10.6.1 Required information on chemical structure
10.7 Design space
10.8 Method operational design region
10.9 Steps engaged in design space
10.10 Design space tools and design of experiments
10.11 Common experimental designs
10.12 Process model for design of experiment
10.13 Two-dimensional model for design space: contour plots
10.14 Three-dimensional models of design space: response surface methodology
10.14.1 Example: in vitro drug release of Losartan potassium
10.15 Advantages of design space approach to analytical methods
10.16 Limitations of design space approach to analytical methods
References
Chapter-11---Design-of-experiments-application-_2021_Handbook-of-Analytical-
11 Design of experiments application for analytical method development
11.1 Introduction
11.2 Fundamental of applying design of experiments
11.3 Key principles of design of experiments
11.3.1 Replication and randomization
11.3.2 Blocking or error control
11.4 Steps in performing design of experiments
11.4.1 Problem conceptualization
11.4.2 Screening of the factors
11.4.2.1 Fractional factorial design
11.4.2.2 Taguchi design
11.4.2.3 Plackett–Burman design
11.4.3 Optimization of the factors
11.4.3.1 Full factorial design
11.4.3.2 Central composite design
11.4.3.3 Box–Behnken design
11.4.3.4 Optimal designs
11.4.3.5 Mixture designs
11.5 Application of design of experiments in analytical development
11.6 Conclusion
References
Index_2021_Handbook-of-Analytical-Quality-by-Design
Index
22ffa95c_Backcover(full permission)
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