Introduction To Toxicological Screening Methods And Good Laboratory Practice

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Introduction to Toxicological Screening Methods and Good Laboratory Practice

Author : Saravana Babu Chidambaram
Publisher : Springer Nature
ISBN 13 : 9811660921
Total Pages : 205 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Introduction to Toxicological Screening Methods and Good Laboratory Practice by : Saravana Babu Chidambaram

Download or read book Introduction to Toxicological Screening Methods and Good Laboratory Practice written by Saravana Babu Chidambaram and published by Springer Nature. This book was released on 2022-02-11 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Toxicological Testing Handbook

Author : Jacobson-Kram David
Publisher : CRC Press
ISBN 13 : 9780824700737
Total Pages : 442 pages
Book Rating : 4.7/5 (7 download)

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Book Synopsis Toxicological Testing Handbook by : Jacobson-Kram David

Download or read book Toxicological Testing Handbook written by Jacobson-Kram David and published by CRC Press. This book was released on 2000-11-21 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Good Laboratory Practice

Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
ISBN 13 : 9780983071914
Total Pages : 276 pages
Book Rating : 4.0/5 (719 download)

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Book Synopsis Good Laboratory Practice by : Mindy J. Allport-Settle

Download or read book Good Laboratory Practice written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2010-10 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and associated documents for pharmaceutical, biologics and medical device products nonclinical trials. Good Laboratory Practice Regulations and Guidance: * FDA Overview and Orientation * Overview of GCP and Introduction to GLP * Part I: Federal Regulations Relating to Good Laboratory Practice o Parts 58: Good Laboratory Practice for Nonclinical Laboratory Studies o 1987 Final Rule - Good Laboratory Practice Regulations * Part II: Guidance Documents o Bioresearch Monitoring Good Laboratory Practice o Good Laboratory Practices Questions and Answers * Part III: Redbook 2000 o IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies o IV.B.2 Guidelines for Reporting the Results of Toxicity Studies Reference Tools * Part IV: Combined Glossary and Index

Good Laboratory Practice Standards

Author : Willa Y. Garner
Publisher : Oxford University Press, USA
ISBN 13 :
Total Pages : 600 pages
Book Rating : 4.:/5 (45 download)

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Book Synopsis Good Laboratory Practice Standards by : Willa Y. Garner

Download or read book Good Laboratory Practice Standards written by Willa Y. Garner and published by Oxford University Press, USA. This book was released on 1992 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experienced quality assurance (QA) professionals and field laboratory researchers. Provides concrete ideas for establishing a compliance program and refining the compliance process. Outlines approaches that have resulted in successful compliance and describes methods of avoiding some of the common mistakes. Appendices contain the entire GLP Enforcement Response Policy, a question-and-answer section, examples of forms for submitting data to the EPA, and the EPA's penalty policy.

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 481 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Good Laboratory Practice

Author : George Edward Paget
Publisher :
ISBN 13 :
Total Pages : 232 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Good Laboratory Practice by : George Edward Paget

Download or read book Good Laboratory Practice written by George Edward Paget and published by . This book was released on 1979 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:

OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)

Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264304797
Total Pages : 172 pages
Book Rating : 4.2/5 (643 download)

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Book Synopsis OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) by : OECD

Download or read book OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 ...

OECD Guidelines for Testing of Chemicals

Author : Organisation for Economic Co-operation and Development
Publisher : Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
ISBN 13 : 9789264122215
Total Pages : pages
Book Rating : 4.1/5 (222 download)

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Book Synopsis OECD Guidelines for Testing of Chemicals by : Organisation for Economic Co-operation and Development

Download or read book OECD Guidelines for Testing of Chemicals written by Organisation for Economic Co-operation and Development and published by Organisation for Economic Co-operation and Development ; [Montréal : Renouf]. This book was released on 1981 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms

Author :
Publisher : DIANE Publishing
ISBN 13 : 1428905375
Total Pages : 275 pages
Book Rating : 4.4/5 (289 download)

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Book Synopsis Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms by :

Download or read book Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms written by and published by DIANE Publishing. This book was released on 2002 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Toxicological Testing Handbook

Author : David Jacobson-Kram
Publisher : CRC Press
ISBN 13 : 9780367390600
Total Pages : 499 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Toxicological Testing Handbook by : David Jacobson-Kram

Download or read book Toxicological Testing Handbook written by David Jacobson-Kram and published by CRC Press. This book was released on 2019-08-30 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author : Ali S. Faqi
Publisher : Academic Press
ISBN 13 : 0123878152
Total Pages : 904 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi

Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-11-02 with total page 904 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 --

Genetic Toxicology Testing

Author : Ray Proudlock
Publisher : Academic Press
ISBN 13 : 0128010061
Total Pages : 460 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Genetic Toxicology Testing by : Ray Proudlock

Download or read book Genetic Toxicology Testing written by Ray Proudlock and published by Academic Press. This book was released on 2016-05-28 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab

Good Laboratory Practice Regulations Management Briefings

Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 60 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Good Laboratory Practice Regulations Management Briefings by : United States. Food and Drug Administration

Download or read book Good Laboratory Practice Regulations Management Briefings written by United States. Food and Drug Administration and published by . This book was released on 1979 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater Organisms

Author :
Publisher :
ISBN 13 :
Total Pages : 380 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater Organisms by :

Download or read book Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater Organisms written by and published by . This book was released on 1994 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Practical Toxicology

Author : David Woolley
Publisher : CRC Press
ISBN 13 : 1498709303
Total Pages : 528 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Practical Toxicology by : David Woolley

Download or read book Practical Toxicology written by David Woolley and published by CRC Press. This book was released on 2017-03-16 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Guide for the Care and Use of Laboratory Animals

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309154006
Total Pages : 246 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guide for the Care and Use of Laboratory Animals by : National Research Council

Download or read book Guide for the Care and Use of Laboratory Animals written by National Research Council and published by National Academies Press. This book was released on 2011-01-27 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.

PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS - I

Author : Dr. Trilochan Satapathy
Publisher : JEC PUBLICATION
ISBN 13 : 9361752359
Total Pages : 254 pages
Book Rating : 4.3/5 (617 download)

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Book Synopsis PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS - I by : Dr. Trilochan Satapathy

Download or read book PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS - I written by Dr. Trilochan Satapathy and published by JEC PUBLICATION. This book was released on with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: The sciences of pharmacology and toxicology are strongly intertwined. The former focuses on how medications function in live beings, while the latter focuses on the bad effects of drugs and chemicals and how to treat them. Both fields are concerned with the behaviour of drugs and chemicals in living organisms. This book provides a detailed illustration of the most important concepts that are involved in pharmacology and the medical sciences that are related to it. The title opens with a discussion of the historical elements of drug creation, including up-to-date information about Nobel Laureates in pharmacology and toxicology and the key discoveries they made. Following this, it conducts an analysis of the fundamental concepts of pharmacology, including pharmacokinetics and pharmacodynamics, as well as providing comprehensive information on drug transporters and interactions. The subsequent chapters of the book are dedicated to covering a comprehensive assortment of subjects that provide vital knowledge on the fundamental principles of pharmacology and the manner in which these concepts are used for the clinical treatment of disorders.