Introduction to Toxicological Screening Methods and Good Laboratory Practice

This book provides a comprehensive guide to the safety, risk, and hazard assessment of small molecules, covering regulatory requirements, methods, and interpretations. It is a valuable resource for pharmacy students, researchers, and practitioners, covering systemic dosage, genotoxicity, special toxicological investigations, and Good Laboratory Practice.

Format: Hardback
Length: 189 pages
Publication date: 12 February 2022
Publisher: Springer Verlag, Singapore

This comprehensive book delves into the intricate principles, methodologies, and interpretations essential for conducting safety, risk, and hazard assessments of small molecules. It serves as a valuable resource for undergraduate and postgraduate pharmacy degree students, as well as senior researchers, seeking to gain a deeper understanding of the principles, methods, and interpretations of systemic dosage (acute and repeated dose) and genotoxicity (in vitro and in vivo), as well as specialized toxicological investigations such as reproductive and developmental toxicology, carcinogenicity, and toxicokinetics using animal models or in vitro methods.

Moreover, this book stands out as the first of its kind in offering comprehensive information on the principles and methods of implementing Good Laboratory Practice based on the guidelines of the Organization for Economic Cooperation and Development (OECD). It provides detailed chapters covering regulatory requirements and guidelines in pharmaceutical products and agrochemicals, as well as the infrastructure necessary for preclinical studies, including in vivo and in vitro facilities.

The book is organized into five chapters, each dedicated to a specific aspect of small molecule safety assessment. Chapter 1 provides an introduction to the field, outlining the importance of small molecules in various industries and the challenges associated with their safety assessment. Chapter 2 discusses the principles of toxicology and pharmacology, which form the foundation for understanding the mechanisms of small molecule toxicity and their interactions with biological systems.

Chapter 3 explores the methods used in small molecule safety assessment, including in vitro and in vivo studies, as well as specialized toxicological investigations. It provides detailed protocols and procedures for conducting these studies, as well as the statistical analysis and interpretation of data. Chapter 4 focuses on the regulatory requirements and guidelines for small molecule safety assessment, including those set forth by the Organization for Economic Cooperation and Development (OECD), the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use, and Schedule 'Y' in India. It outlines the responsibilities of manufacturers, regulators, and researchers in ensuring the safety of small molecules.

Chapter 5 discusses the implementation of Good Laboratory use in small molecule safety assessment, including the establishment of quality control laboratories. It provides detailed guidelines and procedures for ensuring the accuracy, reliability, and reproducibility of data, as well as the documentation and reporting of results.

In conclusion, this book is a valuable resource for anyone involved in small molecule safety assessment, including researchers, regulatory professionals, and industry practitioners. It provides a comprehensive and up-to-date overview of the principles, methods, and interpretations essential for conducting safe and effective small molecule safety assessments. With its detailed chapters, protocols, and procedures, it serves as a practical guide for implementing Good Laboratory Practice and ensuring the safety of small molecules in various industries.

Weight: 489g
Dimension: 235 x 155 (mm)
ISBN-13: 9789811660917
Edition number: 1st ed. 2022