Pharmacokinetics and Toxicokinetic Considerations - Vol II - 1st Edition

Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices.

Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists.

Cover image
Title page
Table of Contents
Copyright
Dedication
List of contributors
Chapter 1. Principles and concepts in toxicokinetic
Abstract
Outline
1.1 Historical background of drug toxicity
1.2 Sources of exposures: point source versus non-point source contamination
1.3 Factors affecting drug toxicity
1.4 Transport mechanisms of drugs
1.5 Uptake and disposition of the drug
1.6 Role of pharmacokinetics in toxicity
1.7 Toxicity types
1.8 Toxicokinetics models
1.9 Conclusion
Abbreviations
References
Chapter 2. Factors influencing drug toxicity
Abstract
Outline
2.1 Introduction
2.2 Factors influencing drug toxicity
2.3 Mechanisms involved in drug toxicity
2.4 Various ways to modify the toxicity of drugs
2.5 Conclusion
Abbreviations
References
Chapter 3. Molecular biology of apoptotic, necrotic, and necroptotic cell death
Abstract
Outline
3.1 Introduction
3.2 Apoptosis and mechanistic aspects of apoptosis activation
3.3 Necrosis and mechanistic events involved in necrotic cell death
3.4 Necroptosis and mechanism involved in necroptosis activation and signaling
3.5 Necroptosis counteracts tumor cells resistance to apoptosis
3.6 Conclusion
Abbreviations
References
Chapter 4. Toxicogenomics in drug safety assessment
Abstract
Outline
4.1 Introduction
4.2 Role of toxicogenomics in the prediction of human toxicants
4.3 Benefits and applications of toxicogenomics in the pharmaceutical industry
4.4 Different bioinformatics methods for the study of toxicoepigenetics
4.5 Role of complementary DNA microarray technology in drug safety analysis and detection of toxicants
4.6 Use of animal models and assays for the study of toxicoepigenetics
4.7 Detection system for epigenetic toxicity
4.8 Environmental toxicants leading to epigenetic toxicity and their role in the development of disorders
4.9 Future directions of toxicogenomics in drug toxicity evaluation
4.10 Conclusion
Abbreviations
References
Chapter 5. Understanding the concept of signal toxicity and its implications on human health
Abstract
Outline
5.1 Introduction
5.2 Signal toxicity
5.3 Endocrine-disrupting chemicals
5.4 Nanoparticles and signal toxicity
5.5 Conclusion
Abbreviations
References
Chapter 6. Importance of toxicity testing in drug discovery and research
Abstract
Outline
6.1 Introduction
6.2 Mechanism of drug toxicity
6.3 Types of toxicity testing
6.4 Toxicity endpoints
6.5 Prerequisite for effective extrapolative in vitro approach
6.6 Various methods for evaluating the toxicity
6.7 Factors affecting the chemical toxicity
6.8 Confronts to toxicity testing and assessment
6.9 Regulatory perspective on the toxicity testing
6.10 Toxicity induced by nanomedicines
6.11 Conclusion
List of abbreviations
References
Chapter 7. Methods and models for in vitro toxicity
Abstract
Outline
7.1 Introduction
7.2 Importance of in vitro toxicity models for screening drugs and safety assessment
7.3 Need for cost-efficient models for in vitro toxicity assessment
7.4 Pitfalls associated with in vitro toxicity model development
7.5 Methods for in vitro toxicity assessment
7.6 Models for in vitro toxicity assessment
7.7 Endpoints for the toxicity assessment
7.8 Application of in vitro toxicity methods and models
7.9 Extrapolation from in vitro to the in vivo situation
7.10 Toxicokinetics
7.11 Requirements for regulatory acceptance
7.12 Conclusion and future directions
List of abbreviations
References
Chapter 8. New emerging technologies for genetic toxicity testing
Abstract
Outline
8.1 Introduction
8.2 In silico tools for genetic toxicity testing
8.3 In vitro testing for genetic toxicity testing
8.4 In vivo assays for genetic toxicity
8.5 Emerging techniques for genetic toxicity
8.6 Conclusion
Abbreviations
References
Chapter 9. Zebrafish models for toxicological screening
Abstract
Outline
9.1 Introduction
9.2 Zebrafish embryo: an animal model
9.3 Toxicological assays using the zebrafish model
9.4 Implementation of zebrafish model as a translational tool in preclinical studies
9.5 Conclusions
Abbreviations
References
Chapter 10. Impact of ageing on the pharmacokinetics and pharmacodynamics of the drugs
Abstract
Outline
10.1 Introduction
10.2 Age-related changes in the pharmacokinetics
10.3 Pharmacodynamic changes in the elderly
10.4 Polypharmacy
10.5 An opinion on areas needs further research
10.6 Conclusions
Abbreviations
References
Chapter 11. Food–drug interactions and their implications on oral drug bioavailability
Abstract
Outline
11.1 Introduction
11.2 Regulatory viewpoint: food–drug interactions in the physiological system
11.3 Effect of food on gastrointestinal physiology and their implications in oral drug delivery
11.4 Some of the specific food–drug interactions
11.5 Formulation approaches to minimize food–drug interactions
11.6 Conclusion
Abbreviations
References
Chapter 12. Drug–drug interactions and their implications on the pharmacokinetics of the drugs
Abstract
Outline
12.1 Introduction
12.2 Pharmacokinetic interactions
12.3 Strategies to prevent pharmacokinetics of drug–drug interaction
12.4 Prediction techniques of drug–drug interactions
12.5 Clinical trials update on drug–drug interaction
12.6 Conclusion
Abbreviations
References
Chapter 13. Clinical importance of herb–drug interaction
Abstract
Outline
13.1 Introduction
13.2 Risk associated with herb–drug interactions
13.3 Mechanism of herb–drug interaction
13.4 Regulatory aspects of herb–drug interactions
13.5 Modeling and simulations as a novel approach to predict herb–drug interaction
13.6 Potential herb–drug interactions
13.7 Conclusion
Abbreviations
References
Chapter 14. In silico methods for the prediction of drug toxicity
Abstract
Outline
14.1 Introduction
14.2 Understanding in silico toxicology and prediction tools
14.3 In silico toxicology modeling methods
14.4 Advances in artificial intelligence–based methods for in silico toxicity prediction
14.5 The perspective of regulatory bodies and the pharmaceutical industry
14.6 Conclusion
Abbreviations
References
Chapter 15. Organ-on-chip for assessing environmental toxicants
Abstract
Outline
15.1 Introduction
15.2 Interventions of organ-on-chip technology in environmental toxins evaluation
15.3 Organ-on-chip in evaluating the environmental toxicants
15.4 Limitations associated with the practical applications of organ-on-chip
15.5 Conclusion
Abbreviations
References
Chapter 16. Toxicity and toxicokinetic considerations in product development and drug research
Abstract
Outline
16.1 Introduction
16.2 Toxicokinetics: pharmacokinetics in toxicology
16.3 Toxicogenomics and biomarkers
16.4 Metabolites in safety testing
16.5 Importance of toxicokinetics
16.6 Conclusion
Abbreviations
References
Chapter 17. Drug toxicity and forensic pharmacokinetics
Abstract
Outline
17.1 Introduction
17.2 Mechanism of drug toxicity
17.3 Contexts of drug toxicity
17.4 Factors affecting drug toxicity
17.5 Scope of toxicology
17.6 Pharmacology of commonly abused drugs
17.7 Drug abuse directions and universality
17.8 Premarketing abuse liability testing of drugs
17.9 Forensic pharmacology and toxicology
17.10 Influence of pharmacokinetics on drug toxicology
17.11 Forensic pharmacokinetics
17.12 Type of forensic samples
17.13 Forensic screening techniques
17.14 Sample preparation for forensic testing
17.15 Analytical strategy
17.16 Global status of drug toxicity, forensic medicine, and forensic pharmacology
17.17 Conclusion
Abbreviations
References
Chapter 18. Excipient toxicity and safety
Abstract
Outline
18.1 Excipient toxicity and safety
18.2 Novel methods for determining the excipient toxicity
18.3 Preclinical view of safety and tolerability of the orphan excipients
18.4 Identification of the adverse reactions to the excipient in the practice
18.5 Excipients-related toxicological concerns
18.6 Excipient toxicities of specific origin
18.7 Current guidelines for excipient toxicity
18.8 Interaction of the excipients on the enzyme and transporter in gastro intestinal tract and their safety concerns
18.9 Conclusion
Abbreviations
References
Chapter 19. Pharmaceutical excipients: special focus on adverse interactions
Abstract
Outline
19.1 Introduction
19.2 What are pharmaceutical excipients?
19.3 Need for excipient compatibility studies between excipients and drugs
19.4 Mechanisms of excipient and drug interactions
19.5 Concern on off-label formulation excipients
19.6 Conclusion
Abbreviations
References
Chapter 20. Emerging role of novel excipients in drug product development and their safety concerns
Abstract
Outline
20.1 Introduction
20.2 Novel excipients: gaining traction in the industry
20.3 Regulatory guidelines of pharmaceutical excipients
20.4 Novel excipients—regulatory challenges and perspectives
20.5 Novel excipients safety
20.6 Adverse effects associated with inactive ingredients in drug products
20.7 Safety concerns of novel excipients primary emphasis on pediatric formulations
20.8 Risk analysis of excipients
20.9 Novel methodologies for risk analysis of pharmaceutical excipients
20.10 Future of excipients: establishment of standards for harmony
20.11 Conclusion
Abbreviations
References
Chapter 21. Toxicity of pharmaceutical azo dyes
Abstract
Outline
21.1 Introduction
21.2 Pharmacology of azo dyes
21.3 Azo dye and human health
21.4 Toxicity of pharmaceutical azo dyes
21.5 Regulatory prospects of azo dyes
21.6 Approaches to reduce toxicity
21.7 Application of azo dyes in the pharmaceutical industry
21.8 Conclusion
Abbreviations
References
Further reading
Chapter 22. Environmental and safety aspects of bionanotechnology
Abstract
Outline
22.1 Bionanotechnology: combining nanotechnology with biology
22.2 Therapeutic applications of BNT-based systems
22.3 Environmental effects of BNT
22.4 Nanopollution and ecological risk
22.5 Specific hazards of some BNT-based systems
22.6 Nanomaterials to subside nanopollution
22.7 Ethics in BNT
22.8 Regulatory aspects of BNT-based systems
22.9 Conclusion
Abbreviations
References
Further reading
Chapter 23. Toxicological assessment of risk of medical devices
Abstract
Outline
23.1 Introduction
23.2 Toxicity testing methods
23.3 Toxicological risk assessment
23.4 Conclusion
Abbreviations
References
Chapter 24. Developmental toxicity of nanomaterials used in drug delivery: understanding molecular biomechanics and potential remedial measures
Abstract
Outline
24.1 Introduction
24.2 Molecular mechanisms associated with nanomaterial toxicity
24.3 Influence of physicochemical properties on nanomaterials toxicity
24.4 Approaches to resolve the developmental toxicity issues of nanomaterials
24.5 Approaches for toxicological assessment of nanomaterial
24.6 Regulatory requirements for the clinical qualification of nanomaterials
24.7 Conclusion
Abbreviations
References
Chapter 25. Ethical defilements in clinical research and potential roles of institutional review board
Abstract
Outline
25.1 Background
25.2 Ethical violations in the history of clinical trials
25.3 Other experiments regarding ethical violations that uplift the designing of IRBs
25.4 Confidentiality
25.5 Informed consent
25.6 Guidelines/principles for clinical trial
25.7 Institutional review board
25.8 Do all the clinical studies require institutional review board review?
25.9 Conclusion
Abbreviations
References
Chapter 26. Toxicokinetic and toxicodynamic considerations in drug research
Abstract
Outline
26.1 Toxicodynamics
26.2 Toxicokinetics-toxicodynamics association
26.3 Engagement of toxicokinetics-toxicodynamics in risk assessment
26.4 Applications of toxicodynamics in the management of poisoned patients
26.5 Toxicokinetic and toxicodynamic considerations in drug research
26.6 Conclusion
Abbreviations
References
Further reading
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Pharmacokinetics and Toxicokinetic Considerations - Vol II

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Rakesh Kumar Tekade