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.

Introduction to Toxicology: The Necessity of Measurement. Normality: Definition and Maintenance. Determination of Toxicity: The Basic Principles. Determination of Toxicity: In Vitro and In Silico. Safety Pharmacology. Determination: General and Reproductive Toxicology. Distinguishing a Toxicological Effect from an Expected Pharmacological One. Determination: Genotoxicity and Carcinogenicity. Determination: Dermal Toxicity—Sensitization, Irritation, and Corrosion. Determination of Immunotoxicity: Biologics and Beyond. Determination of Nanotoxicity. Determination: Environmental Toxicology and Ecotoxicology. Interpretation: Basic Principles. Interpretation: Different Data Types. Prediction of Hazard. Background to Risk Due to Toxicity. Risk Assessment in Practice and Setting Exposure Limits. Risk Assessment for Extractables, Leachables, and Impurities. Risk Assessment and Management in the Workplace. Risk Assessment: Carcinogenicity; The Environment, Evolution, and Overview of Risk Assessment. Evaluation of Specific Classes of Chemical. Errors in Toxicology: An Introduction to the 4Ms. The Future of Toxicity Testing and Risk Assessment.