Pharmacokinetics and Toxicokinetic Considerations - Vol II

Pharmacokinetics and Toxicokinetic Considerations - Vol II

1st Edition - February 5, 2022

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  • Editor: Rakesh Tekade
  • Hardcover ISBN: 9780323983679
  • eBook ISBN: 9780323913164

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Description

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.

Key Features

  • Allows readers to systematically integrate up-to-date research findings into their laboratory work
  • Presents focused explorations of bioanalytical methods for bioavailability and bioequivalence assessment
  • Provides clinical applications of concepts

Readership

Researchers in pharmacokinetics and scientists who work on animals from both academia and industry. Researchers and advanced students in Pharmaceutical Sciences, Bioengineering, Pharmacology, Drug Development and Chemistry

Table of Contents

  • 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

Product details

  • No. of pages: 814
  • Language: English
  • Copyright: © Academic Press 2022
  • Published: February 5, 2022
  • Imprint: Academic Press
  • Hardcover ISBN: 9780323983679
  • eBook ISBN: 9780323913164

About the Editor

Rakesh Tekade

Dr Rakesh K Tekade, Assistant Professor of the Department of Pharmaceutics, investigates the design, development and characterization of targeted nanotechnology based formulations for the site specific delivery of therapeutic drugs, siRNA, microRNA, plasmids, proteins and peptide for the treatment of cancer. His current research encompasses development of novel polymeric nanomaterial for effective cytosolic delivery of anticancer bioactives. Dr Tekade’s research is focused on designing a new generation of nanoparticles, which could identify the cancer cells and selectively deliver anticancer drugs and genes to inhibit the growth of cancer while sparing healthy tissues. His research work involves the applications of polymer chemistry, nanotechnology, molecular biology, pharmacokinetics/pharmacodynamics and imaging techniques. Dr Tekade has over 70 publications, 01 patent, 7 book chapters, and 3 editorial articles. He has delivered several invited research talks and presented research finding in more than 30 scientific conferences.

Affiliations and Expertise

Assistant Professor, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research Ahmedabad, Gujarat, India

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