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 degree students, senior researchers, and practitioners in the pharmaceutical and agrochemical industries.

Format: Paperback / softback
Length: 189 pages
Publication date: 14 February 2023
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 techniques for conducting these studies, as well as the interpretation of data obtained. 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 steps involved in obtaining regulatory approval for small molecule products and the responsibilities of manufacturers and regulatory agencies.

Chapter 5 discusses the future of small molecule safety assessment, including emerging technologies and new approaches to risk management. It highlights the need for continuous improvement and collaboration among stakeholders to ensure the safety and efficacy of small molecule products.

In conclusion, this book is a valuable resource for anyone involved in the safety assessment of small molecules. It provides a comprehensive and up-to-date overview of the principles, methods, and interpretations of small molecule safety assessment, as well as the regulatory requirements and guidelines that apply to these products. With its detailed chapters and practical protocols, it is an essential tool for undergraduate and postgraduate pharmacy degree students, senior researchers, and industry professionals seeking to stay informed about the latest developments in this field.

Weight: 332g
Dimension: 235 x 155 (mm)
ISBN-13: 9789811660948
Edition number: 1st ed. 2022