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Insight on Genotoxicity [Hardback]

(Columbia Institute of Pharmacy, India), (Columbia Institute of Pharmacy, Raipur, India), (Columbia Institute of Pharmacy, Raipur, India), (Columbia Institute Of Pharmacy, India)
  • Formāts: Hardback, 152 pages, height x width: 234x156 mm, weight: 470 g, 8 Tables, black and white; 6 Illustrations, color
  • Izdošanas datums: 15-Oct-2020
  • Izdevniecība: CRC Press
  • ISBN-10: 0367473372
  • ISBN-13: 9780367473372
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Insight on GenotoxicityPalielināt
  • Formāts: Hardback, 152 pages, height x width: 234x156 mm, weight: 470 g, 8 Tables, black and white; 6 Illustrations, color
  • Izdošanas datums: 15-Oct-2020
  • Izdevniecība: CRC Press
  • ISBN-10: 0367473372
  • ISBN-13: 9780367473372
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9780367473372.html
Keywords:
Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint.

Salient Features











Presents methods, standard protocols, and guidelines for genotoxicity testing





Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development





Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects





Discusses advancement in the high-throughput approaches for genotoxicity testing





Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development
Preface xiii
Acknowledgement xv
Authors xvii
Chapter 1 Introduction to Genotoxicity
1(8)
Introduction to Genotoxicity
1(1)
Importance of Genotoxicity Studies
1(1)
Classification of Carcinogens
2(1)
Agents Causing Direct or Indirect Damage to the DNA
3(1)
Molecular Mechanisms Involved in Production of Chromosomal Aberrations
4(1)
Direct Repair
4(1)
Base Excision Repair (BER)
4(1)
Nucleotide Excision Repair (NER)
5(1)
Mismatch Repair (MMR)
5(1)
Chromosomal Aberrations and Repair
6(1)
Homologous Recombination Repair
6(1)
Non-Homologous End Joining Repair
7(1)
Conclusion
7(1)
References
8(1)
Chapter 2 Genotoxicity and DNA Repair
9(6)
Introduction
9(1)
DNA Damage
10(1)
DNA Repair and Apoptosis
11(2)
Conclusion
13(1)
References
13(2)
Chapter 3 Consequence of DNA Damage
15(8)
Introduction
15(1)
DNA Mutilation/Damage
15(1)
Consequences of DNA Damage
16(1)
DNA Damage in Mammalian Reproductive Cell
16(1)
Ageing -- State of Deterioration
17(1)
Lymphoidal Cells and DNA Damage
17(1)
Neurodegenerative Disorders
18(1)
Genome Instability and Heritable Diseases
18(1)
Cardiovascular Diseases and Metabolic Syndrome
19(1)
Cancer
19(1)
Viral, Parasitic and Certain Other Diseases
19(1)
Conclusion
20(1)
References
20(3)
Chapter 4 Mechanism of Genotoxicity
23(6)
Introduction
23(3)
Standard Test Battery for Genotoxicity
26(1)
Testing for Gene Mutation in Bacteria
26(1)
In-vitro Testing Methods
27(1)
Conclusion
27(1)
References
27(2)
Chapter 5 Impact of ICH Guidelines on Genotoxicity Testing Dogmatic Obligation for Innovation Drug Discovery and Development
29(12)
Introduction
29(1)
Budge in Drug Discovery Hypothesis
29(1)
Responsibility of National and International Dogmatic Authorities
30(1)
Precincts of the Regulatory System to Test Genotoxicity
31(1)
Genotoxicity Testing Procedures Used in Regulatory Toxicity
31(1)
Principle of Genotoxicity Testing
32(1)
The Concept of Test Batteries
32(1)
Criteria for Test Battery Selection
33(1)
Drawbacks of Current Genotoxicity Tests
33(1)
ICH Guidelines
33(1)
In-Vitro Studies
34(1)
In-Vivo Studies
34(1)
Variation of the Test Battery
35(1)
Specific Recommendations
36(1)
In-Vitro Test Results
36(1)
In-Vivo Test Results
37(1)
Detection of Germ Cell Mutagens
37(1)
Additional Requirements for Specific Situation
37(1)
Impact of ICH Guidelines
38(1)
Novel Methods in Genotoxicity Testing
38(1)
Conclusion
38(1)
References
39(2)
Chapter 6 Genotoxicity Prediction; Computational Prediction
41(6)
Introduction
41(1)
Mutagenicity
42(1)
QSAR Approaches
42(1)
Chromosome Damage
43(1)
Strategies for Genotoxicity Prediction in Drug Development
44(1)
Conclusion
45(1)
References
45(2)
Chapter 7 Computational Prophecy of Genotoxicity with Models
47(10)
Introduction
47(1)
Principal Thespians
48(1)
DEREK System Deductive Estimation of Risk from Existing Knowledge
48(1)
MCASE (Multiple Computer Automated Structure Evaluation)
48(1)
TOPKAT (Toxicity Prediction by Komputer Assisted Technology)
49(1)
QSAR Models
49(1)
DNA Docking Model
50(1)
Consensus Modeling
50(1)
Drawing a Parallel Prophecy
50(1)
Sensitivity
51(1)
Specificity
52(1)
What Causes This High Number of False Positive Predictions?
53(1)
Genotoxic Potency
53(1)
Conclusion
54(1)
References
55(2)
Chapter 8 Bioindicator of Genotoxicity: The Allium cepa Test
57(8)
Introduction
57(1)
Depiction and Magnitude of the Allium cepa Test
58(1)
Methodology of the Allium cepa Test
59(1)
Experimental Procedure
59(2)
Exploit as an `ADMONITION' Bioindicator in Detecting Genotoxicity of Medicinal Plants
61(1)
Category of Consequences and Elucidation Through the Scrutiny of Plant Cytogenetics
62(1)
Conclusion
63(1)
References
63(2)
Chapter 9 Genotoxicity Appraisal of Nano-Sized Materials and Particles
65(10)
Introduction
65(1)
Nanoparticle-Induced Genotoxicity and Underlying Mechanisms
66(1)
Primary Genotoxicity -- Direct and Indirect Mechanisms
66(1)
Secondary (Inflammation-Induced) Genotoxicity
67(1)
Genotoxicity Appraisal of Nanomaterials
67(1)
Comet Assay
68(1)
Assay Methodology
68(1)
Can the Method Be Applied to Nanomaterials?
69(1)
Micronucleus Assay
69(1)
Chromosome Aberrations
70(1)
Bacterial Mutagenicity Test
70(1)
Mammalian Mutagenicity Tests
70(1)
Cell Transformation
71(1)
High-Throughput Methods
71(1)
Conclusion
72(1)
References
73(2)
Chapter 10 Genotoxicity Evaluation in Phytopharmaceuticals: Perspective Review
75(18)
Introduction
75(1)
Need of Toxicity Study for Herbal Medicinal Products
76(1)
Genotoxicity in HMPs
76(1)
Regulatory Aspects for Genotoxicity in HMPs
77(1)
Genotoxicity Assessment
78(1)
In-Silico Prediction Method
79(1)
Benefits
79(1)
Limitations
79(1)
Structure Alert Method or Toxicophores
80(1)
In-Vitro Methods
80(1)
Benefits
80(1)
Limitations
80(1)
In-Vivo Methods
80(1)
Benefits
81(1)
Limitations
81(1)
Step 1 Bacterial Reverse Mutation Test/the Ames Test
82(1)
Equivocal Test Result
82(1)
Step 2 The Mouse Lymphoma Assay or Other Mammalian Cell Assay
82(1)
Step 3 The Rodent Micronucleus Test
83(1)
Step 4 The Risk Assessment Considerations
83(1)
Application of the Bracketing and Matrixing
84(1)
Allium cepa Test
85(1)
Advantages
86(1)
Novel Approaches for Genotoxicity Testing
86(1)
Discussion and Conclusion
87(2)
References
89(4)
Chapter 11 Deterrence of Genotoxicity: Brief Perspective
93(8)
Introduction
93(1)
History of Regulations Until 2004
94(1)
Pharmaceutical Industry Response in 2005 and 2006
95(1)
Control Strategies
96(1)
Avoidance
96(1)
Adjust API Process
96(1)
Demonstrate GTI Threshold Mechanism Above TTC Level
97(1)
Two Special Cases Have Been Mentioned Below
97(1)
Proficient Opinion
98(1)
Conclusion
98(1)
References
98(3)
Chapter 12 Genotoxic and Non-Genotoxic Chemicals for Review of the Performance Improved Genotoxicity
101(12)
Introduction
101(2)
Contemplations for Revising Group 1
103(1)
Contemplations for Revising Group 2
104(1)
Contemplations for Revising Group 3
105(3)
Note on Concordance
108(1)
Conclusion
108(1)
References
108(5)
Chapter 13 Genotoxic Impurities in Pharmaceuticals
113(12)
Introduction
113(1)
Dogmatic Implications: Regulations and Guidelines
114(1)
Guidelines for Genotoxic Impurities, Control, Testing, and Risk Assessment [ 3]
115(1)
PhRMA Position Paper
115(1)
European Medicines Agency (EMA) Guidelines
115(2)
Food Drug Administration (FDA)
117(1)
International Council for Harmonization (ICH)
117(1)
Classes of Genotoxic Impurities
118(1)
Threshold of Toxicological Concern (TTC) Approach
118(1)
Risk Assessment of Impurity
119(1)
Seclusion of Genotoxic Impurities
119(1)
Analysis of Impurities
120(1)
Analytical Method Development
120(1)
Analytical Method Validation
121(1)
Linearity and Range
121(1)
Accuracy
121(1)
Precision
122(1)
Sensitivity and Specificity
122(1)
Robustness and Ruggedness
122(1)
Conclusion
123(1)
References
123(2)
Chapter 14 Genotoxicity and Carcinogenicity Predictive Software Systems
125(8)
Introduction
125(1)
Toxtree
126(1)
CAESAR
127(1)
Lazar
128(1)
HazardExpert
129(1)
DEREK
129(1)
ToxBoxes
130(1)
References
131(2)
Chapter 15 Poultry Manure Induced DNA Damage
133(12)
Introduction
133(1)
Protocols
134(1)
Materials and Methods
134(1)
LMH Cell Culture
134(1)
Comet Assay (SCGE---Single Cell Gel Electrophoresis Assay) -- Protocol
135(1)
Lactate Dehydrogenase Activity (LDH) Assay -- Protocol
135(1)
Calculation of IC50 -- Protocol
136(1)
Fluorescence Microscopic Analysis -- Protocol
137(1)
Statistical Analysis
137(1)
General Notations
137(1)
Discussion
138(3)
Conclusion
141(1)
References
141(4)
Chapter 16 Expert Opinion on the Basis of the Content and Easy Understandable Rundown for the Reader
145(6)
Introduction
145(6)
Index 151
Dr. Shiv Shankar Shukla obtained his Ph.D from University Institute of Pharmacy, Pt. Ravi Shankar Shukla University. Presently he is Professor at Columbia Institute of Pharmacy. He has more than 65 publications to his credit in reputed journals. He has authored two books titled "Inflammation: Natural Resources and Its Applications" and "Finger Printing Analysis and Quality Control Methods of Herbal Medicines". He has written three book chapters published in reputed Publishing House.

Dr. Ravindra Pandey gained his Ph.D from University Institute of Pharmacy, Pt. Ravi Shankar Shukla University. Presently he is Professor at Columbia Institute of Pharmacy. He has more than 65 publications to his credit in reputed journals. He has authored two books titled "Inflammation: Natural Resources and Its Applications" and "Finger Printing Analysis and Quality Control Methods of Herbal Medicines". He has written three book chapters in reputed Publishing House.

Dr. Bina Gidwani obtained her Ph. D from University Institute of Pharmacy, Pt. Ravishankar Shukla University. Presently, she is serving as Associate Professor at Columbia Institute of Pharmacy. She has more than 55 publications to her credit. She has authored one book and two book chapters in reputed Publishing House.

Mr. Gunjan Kalyani is Post Graduate from Chhattisgarh Swami Vivekanada Technical University (CSVTU), Bhilai, Chhattisgarh. Presently, he is Assistant Professor at Columbia Institute of Pharmacy. He has 26 publications to his credit in various journals of International and National repute.