Author: Saravana Babu Chidambaram
Publisher: Springer Nature
ISBN: 9811660921
Category : Medical
Languages : en
Pages : 205
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Book Description
This book focuses on the principles, methods, and interpretation involved in establishing the safety, risk, and hazard assessment of small molecules. It presents the regulatory requirements for risk and hazard identification as per the guidelines of the Organization for Economic Cooperation and Development (OECD), Paris, and the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use ICH and Schedule ‘Y’, India. It serves as reference material for undergraduate and postgraduate pharmacy degree students as well as senior researchers to learn about the principles, methods, and interpretations of systemic dosage (acute and repeated dose) and genotoxicity (in vitro and in vivo), special toxicological investigations such as reproductive and developmental toxicology, carcinogenicity, and toxicokinetics using animal models or in vitro methods, as applicable. This book is the first of its kind in providing information on the principles and methods of implementation of Good Laboratory Practice based on the guidelines of OECD. It includes detailed chapters about the regulatory requirements and guidelines in pharmaceutical products and agrochemicals. It also describes the infrastructure needed for preclinical studies, including in vivo and in vitro facilities.
Author: Dr. Trilochan Satapathy
Publisher: JEC PUBLICATION
ISBN: 9361759019
Category : Medical
Languages : en
Pages : 244
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Book Description
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.
Author: Swetlana
Publisher:
ISBN:
Category : Education
Languages : en
Pages : 0
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Book Description
Author: Prabha Manjari
Publisher:
ISBN:
Category : Education
Languages : en
Pages : 0
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Book Description
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878152
Category : Business & Economics
Languages : en
Pages : 904
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Book Description
A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --
Author: Jacobson-Kram David
Publisher: CRC Press
ISBN: 9780824700737
Category : Medical
Languages : en
Pages : 442
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Book Description
Designed to aid toxicology testing study design, this text provides data on issues such as species selection, dose level and dosing regimes, animal models, routes of exposure, statistical evaluation, data interpretation, fulfillment of regulatory requirements, and adherence to good laboratory practices.
Author: Garnepudi Sandeep Kumar
Publisher: Notion Press
ISBN:
Category : Reference
Languages : en
Pages : 0
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Book Description
In-Depth Coverage: The book delves into essential topics such as acute, sub-acute, and chronic toxicity studies, reproductive and genotoxicity studies, IND enabling studies, and safety pharmacology, offering a balanced mix of theory and practical insights. Regulatory Compliance: Emphasis is placed on understanding and adhering to regulatory guidelines from bodies such as the OECD, ICH, and EPA, ensuring that readers are well-versed in the standards required for pharmacological and toxicological studies. Innovative Methodologies: The book explores alternative methods to animal testing, including in vitro and in silico approaches, reflecting the latest trends and ethical considerations in the field. Comprehensive Illustrations: Diagrams, tables, and flowcharts are included to aid in the visualization of complex processes and enhance the learning experience. Practical Applications: Case studies and practical examples are provided to illustrate the real-world applications of the screening methods discussed, bridging the gap between academic learning and professional practice.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264304797
Category :
Languages : en
Pages : 206
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Book Description
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
Author: David Jacobson-Kram
Publisher: CRC Press
ISBN: 9780849338588
Category : Medical
Languages : en
Pages : 499
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Book Description
Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance. Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on data interpretation, hazard assessment, carcinogenicity studies, and Good Laboratory Practices, new chapters regarding safety pharmacology, juvenile studies, the health safety assessment of pharmaceuticals, and health assessment strategies in the food and cosmetic industry have been added to reflect changes to regulatory requirements. Toxicological Testing Handbook, Second Edition is a must-have reference for individuals responsible for assuring the safety of new pharmaceutical, biotechnical, and chemical products and materials.
Author:
Publisher: DIANE Publishing
ISBN: 1428905375
Category : Water quality biological assessment
Languages : en
Pages : 275
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Book Description
