Regulatory Toxicology

Franz-Xaver Reichl studied Microbiology and Medicine in Munich, Germany. He is Head of the Department of Dental Toxicology at the Department of Operative/Restorative Dentistry, Periodontology and Pedodontics, LMU Munich and Head of the International Advisory Centre for the toxicology and biocompatibility of dental materials. His field of research cover studies on cytotoxic, mutagenic, carcinogenic and embryotoxic effects of chemical compounds (e.g. dental materials) in human and animal cells, abrasion of composites and elution of dental composite components during the chewing situation in the chewing simulator MUC/3 and in vitro- and in vivo studies on toxicokinetic and toxicodynamic effects of chemical compounds (e.g. dental materials). He also work on studies on the pathways and on the analysis of intermediates in the metabolism of dental composite components in biological systems and risk assessments of xenobiotics (e.g. dental materials). Michael Schwenk studied Biochemistry and Medicine in Tuebingen, Germany. He then qualifiedas a toxicologist and pharmacologist and worked in universities, industry and a health agency. He initially focused on experimental cell toxicology, but later shifted to the measurement of chemical residues in humans and to study the health effects of such exposures in different populations. He was active in various national regulatory committees, advised the colleagues of the public health service of Baden-Württemberg and received practical experience in all major areas of regulatory toxicology.

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Postmortem Toxicology of Abused Drugs 1st Edition

Extracted from the Drug Abuse Handbook, 2nd edition, to give you just the information you need at an affordable price.

Postmortem Toxicology of Abused Drugs considers the role of toxicology in the investigation of homicide, suicide, accident, natural death, and overdose. It gives practical insights and case reviews on conducting toxicology tests and completing toxicology reports. It explains chain of custody; specimen collection and security; sampling of blood, urine, bile, and vitreous humor; and the selection of post-mortem specimens. Analyzing various testing procedures, the book covers simple chemical tests, microdiffusion tests, chromatography, spectroscopy, and more. It also discusses methods and strategies for analysis; and covers quality assurance protocols and controls. To help avoid common pitfalls, the text demonstrates the proper interpretation of postmortem drug levels based on knowledge of pharmacokinetics, metabolism, and pharmacogenetics; post-mortem redistribution and diffusion; and other considerations such as synergistic toxicity, and drug instability. Heavily referenced and containing several tables, figures, and useful appendices, this book is a handy reference for forensic scientists and medical examiners involved with death investigation.

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Toxins and Drug Discovery (Toxinology) 1st ed. 2017 Edition

This volume deals mainly with the specialized aspect of toxins and drug discovery. Man has been using natural resources especially plants to treat diseases from very early times in history of mankind. Although many drugs derived from plants and microbes have been discovered and being used in clinical practice, not many drugs have been developed from venoms and toxins although many laboratories worldwide are actively working on it. This volume describe some of the recent developments in this research area, such as snake venoms, conotoxins , bioinformatics in drug discovery from peptide toxins.

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Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition 3rd Edition

Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future.

New Chapters in the Third Edition:

    • Toxicology in silico

  • Errors in Toxicology
  • Safety Assessment of Extractables and Leachables.

This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world.

Completely revised and written in an easily accessible style, the text address several audiences―from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.

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Toxicology Recall (Recall Series) 1st Edition

Written primarily for third and fourth year medical students, Toxicology Recall is a complete, concise review of clinical toxicology. The book is written in the rapid-fire question-and-answer format of the Recall Series, with the question appearing on the left side of the page and the answer appearing on the right. Mnemonics and reference charts further aid in rapid review. Major sections cover evaluation of the poisoned patient, medications, drugs of abuse, environmental and industrial toxins, heavy metals, pesticides, chemical agents of terrorism, natural toxins, therapies, and visual diagnosis in medical toxicology.

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Clarke’s Analytical Forensic Toxicology 2nd Edition

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This invaluable textbook, written by international experts, covers all the main elements of forensic toxicology and analytical toxicology techniques as well as the important parts of pharmacokinetics, drug metabolism, and pharmacology in general, with a particular focus on drugs of abuse.

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Validation of Alternative Methods for Toxicity Testing (Advances in Experimental Medicine and Biology) 1st ed. 2016 Edition

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This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology.

 

Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment.

 

This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

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Antioxidants in Biology and Medicine: Essentials, Advances, and Clinical Applications 1st Edition

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This is a book that takes a unique approach to integrating knowledge in antioxidants from essentials to advances, and from basic research to clinical applications. This book presents scientific information on antioxidants in an organised, cogent, and in-depth manner. The consistent format of writing, the full-colour illustrations, and the comprehensive list of references make the book accessible and engaging. Besides its value as a textbook for undergraduate and graduate students in life science, “Antioxidants in Biology and Medicine” will also be a useful reference for biomedical research scientists, clinicians, and other health professionals.

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Goldfrank’s Toxicologic Emergencies, Ninth Edition (Goldfrank’s Toxicologic Emergenciess)) 9th Edition

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The most trusted, rigorous, and up-to-date toxicology resource and educational companion available – now in full color

A Doody’s Core Title ESSENTIAL PURCHASE for 2011!

Goldfrank’s Toxicologic Emergencies continues to be the source you can turn to first for any poisoning or overdose. The text provides clear information on every aspect of toxicologic emergencies, from pharmacology to clinical presentation to management.

Fully referenced and featuring a consistent organization, Goldfrank’s begins with an in-depth examination of general principles of medical toxicology. It then progresses to the biochemical principles and molecular basis of toxicology, and provides detailed insight into how xenobiotics affect vital signs, organs, and systems throughout the body. Next, a wide spectrum of clinically important exposures — including drugs, plants, metals, household products, occupational and environmental xenobiotics are covered within logical categories for easy access to information. Finally, the book concludes with sections on principles of practicing clinical toxicology in today’s challenging healthcare environment.

NEW TO THIS EDITION

  • Full-color design and uniformly drawn figures clarify key concepts
  • Special Considerations focus on decision-making in unique toxicologic circumstances, that influence clinical practice and have the potential to improve patient care
  • Antidotes in Depth, following pertinent chapters, place each antidote in its proper context to ensure immediate availability of essential information relevant for clinical use
  • More clinically-relevant figures and quick-reference tables
  • Online learning center, available at www.goldfrankstoxicology.com, includes case studies, and a database of multiple choice questions that allow you to create a custom test for review and study.
  • Every chapter is thoroughly rewritten and new chapters are added to reflect the very latest thinking in the field

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Casarett & Doull’s Toxicology: The Basic Science of Poisons, Eighth Edition 8th Edition

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The most trusted all-in-one overview of the biomedical and environmental aspects of toxicology–NOW more complete, up-to-date, and in full color

A Doody’s Core Title for 2015!

NEW to the Eighth Edition

  • FULL-COLOR design to allow for a clearer interpretationof the basic components of toxicology featured throughout the text
  • EXPANDED tables, illustrations, and other visuals areupdated with state-of-the-art standards that makes thisedition even more current and relevant
  • DVD with image bank features all tables and illustrations from the text in presentation-ready format
  • NEW CHAPTERS include “Toxic Effects of Calories”and “Toxic Effects of Nanoparticles”

The world’s leading and most authoritative textbook on poisons has more to offer students,toxicologists, and pharmacologists than ever before. Now in full color, and thoroughly revised, the eighth edition of Casarett & Doull’s TOXICOLOGY: The Basic Science of Poisons not only delivers a comprehensive review of the essential components of toxicology, it offers the most up-to-date,revealing, and in-depth look at the systemic responses of toxic substance available anywhere.

Combined with the latest thinking by the field’s foremost scholars plus solid coverage of general principles, modes of action, and chemical-specific toxicity, this landmark text continues to set the standard for toxicology references.

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