Introduction To Toxicological Screening Methods And Good Laboratory Practice
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Introduction To Toxicological Screening Methods And Good Laboratory Practice
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Author : Saravana Babu Chidambaram
language : en
Publisher: Springer Nature
Release Date : 2022-02-11
Introduction To Toxicological Screening Methods And Good Laboratory Practice written by Saravana Babu Chidambaram and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-11 with Medical categories.
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.
Good Laboratory Practice Standards
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Author : Willa Y. Garner
language : en
Publisher: Oxford University Press, USA
Release Date : 1992
Good Laboratory Practice Standards written by Willa Y. Garner and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Pesticides categories.
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.
Good Laboratory Practice
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Author : Mindy J. Allport-Settle
language : en
Publisher: Pharmalogika
Release Date : 2010-10
Good Laboratory Practice written by Mindy J. Allport-Settle and has been published by Pharmalogika this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10 with Medical categories.
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
Principles Of Safety Pharmacology
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Author : Michael K. Pugsley
language : en
Publisher: Springer
Release Date : 2015-06-19
Principles Of Safety Pharmacology written by Michael K. Pugsley and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-06-19 with Medical categories.
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.
Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2018-12-10
Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-10 with categories.
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 ...
Pharmacological And Toxicological Screening Methods I
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Author : Dr. Trilochan Satapathy
language : en
Publisher: JEC PUBLICATION
Release Date :
Pharmacological And Toxicological Screening Methods I written by Dr. Trilochan Satapathy and has been published by JEC PUBLICATION this book supported file pdf, txt, epub, kindle and other format this book has been release on with Medical categories.
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.
A Comprehensive Guide To Toxicology In Preclinical Drug Development
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Author : Ali S. Faqi
language : en
Publisher: Academic Press
Release Date : 2012-11-02
A Comprehensive Guide To Toxicology In Preclinical Drug Development written by Ali S. Faqi and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-02 with Business & Economics categories.
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 --
Antibiotics
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Author : Peter Sass
language : en
Publisher: Springer Nature
Release Date : 2022-11-29
Antibiotics written by Peter Sass and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-29 with Science categories.
This second edition provides state-of-the-art and novel methods on antibiotic isolation and purification, identification of antimicrobial killing mechanisms, as well as methods for the analysis and detection of microbial responses and adaptation strategies. Antibiotics: Methods and Protocols, Second Edition, guides readers through updated and entirely new chapters on production and design, mode of action, and response and resistance. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Antibiotics: Methods and Protocols, Second Edition aims to inspire scientific work in the exciting field of antibiotic research.
Practical Toxicology
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Author : David Woolley
language : en
Publisher: CRC Press
Release Date : 2017-03-16
Practical Toxicology written by David Woolley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-03-16 with Medical categories.
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.
High Throughput Screening Methods In Toxicity Testing
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Author : Pablo Steinberg
language : en
Publisher: John Wiley & Sons
Release Date : 2013-02-26
High Throughput Screening Methods In Toxicity Testing written by Pablo Steinberg and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-26 with Science categories.
Explores the benefits and limitations of the latest high-throughput screening methods With its expert coverage of high-throughput in vitro screening methods for toxicity testing, this book makes it possible for researchers to accelerate and streamline the evaluation and risk assessment of chemicals and drugs for toxicity. Moreover, it enables them to comply with the latest standards set forth by the U.S. National Research Council's "Toxicity Testing in the 21st Century: A Vision and Strategy" and the E.U.'s REACH legislation. Readers will discover a variety of state-of-the-science, high-throughput screening methods presented by a group of leading authorities in toxicology and toxicity testing. High-Throughput Screening Methods in Toxicity Testing is divided into five parts: General aspects, including predicting the toxicity potential of chemicals and drugs via high-throughput bioactivity profiling Assessing different cytotoxicity endpoints Assessing DNA damage and carcinogenesis Assessing reproductive toxicity, cardiotoxicity, and haematotoxicity Assessing drug metabolism and receptor-related toxicity Each chapter describes method principles and includes detailed information about data generation, data analysis, and applications in risk assessment. The authors not only enumerate the advantages of each high-throughput method over comparable conventional methods, but also point out the high-throughput method's limitations and potential pitfalls. In addition, the authors describe current research efforts to make high-throughput toxicity screening even more cost effective and streamlined. Throughout the book, readers will find plenty of figures and illustrations to help them understand and perform the latest high-throughput toxicity screening methods. This book is ideal for toxicologists and other researchers who need to implement high-throughput screening methods for toxicity testing in their laboratories as well as for researchers who need to evaluate the data generated by these methods.