Introduction to Toxicological Screening Methods and Good Laboratory Practice PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Introduction to Toxicological Screening Methods and Good Laboratory Practice PDF full book. Access full book title Introduction to Toxicological Screening Methods and Good Laboratory Practice by Saravana Babu Chidambaram. Download full books in PDF and EPUB format.
Author: Saravana Babu Chidambaram
Publisher: Springer Nature
ISBN: 9811660921
Category : Medical
Languages : en
Pages : 205
Get Book
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: Saravana Babu Chidambaram
Publisher: Springer Nature
ISBN: 9811660921
Category : Medical
Languages : en
Pages : 205
Get Book
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: Jacobson-Kram David
Publisher: CRC Press
ISBN: 9780824700737
Category : Medical
Languages : en
Pages : 442
Get Book
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: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878152
Category : Business & Economics
Languages : en
Pages : 904
Get Book
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: George Edward Paget
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 232
Get Book
Book Description
Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780983071914
Category : Medical
Languages : en
Pages : 276
Get Book
Book Description
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
Author: Willa Y. Garner
Publisher: Oxford University Press, USA
ISBN:
Category : Language Arts & Disciplines
Languages : en
Pages : 600
Get Book
Book Description
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.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264304797
Category :
Languages : en
Pages : 206
Get Book
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: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 60
Get Book
Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428905375
Category : Water quality biological assessment
Languages : en
Pages : 275
Get Book
Book Description
Author: David Jacobson-Kram
Publisher: CRC Press
ISBN: 9780367390600
Category :
Languages : en
Pages : 499
Get Book
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.
