PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

ISBN NO:- 978-93-6175-901-7

A complete handbook on toxicology covers basic principles, regulatory criteria, and
sophisticated methods for understanding and assuring the safety of varied chemicals in the
following pages. Introduction to toxicology, “Toxicology Fundamentals and Regulatory
Guidelines,” covers broad overviews, mechanistic toxicology, regulatory frameworks, and
descriptive toxicology. Focus is on OECD, ICH, EPA, and Schedule Y regulatory criteria, as
well as the history and importance of Good Laboratory Practise (GLP) in drug development.
As the book explores “Types of Toxicity Studies and Test Item Characterization,” it examines
acute, sub-acute, chronic, and particular acute investigations, including oral, cutaneous, and
inhalational toxicity studies. Test item characterisation procedures are carefully explained,
emphasising their importance in regulatory compliance and toxicity evaluation.
This leads to “Advanced Toxicology Studies,” which covers reproductive toxicology,
genotoxicity, and in vivo carcinogenicity. These investigations provide a thorough view of
possible dangers and evaluate drug safety.
The book then discusses “IND Enabling Studies and Safety Pharmacology,” which covers the
necessary research for IND applications. Exploring regulatory settings, corporate views, and
safety pharmacology in drug development provides a complete knowledge of experimental
substance safety.
The third part, “Toxicokinetic and Alternatives to Animal Testing,” emphasises toxicokinetic
assessment and discusses new methods. Following the evolution of safety assessment practises,
these options are investigated for ethical and regulatory consequences.
Students, researchers, and professionals traversing toxicology’s difficult landscape may find
this book invaluable. Its extensive coverage, from basic concepts to sophisticated approaches,
makes it an important tool for protecting humans and ecosystems in the dynamic
pharmaceuticals and beyond industries.