Good Laboratory Practice Regulations Management Briefings PDF Download

Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 60

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Book Description

Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 106

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Book Description

Author: USA. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 53

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Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256

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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249

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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g

Author: Milton A. Anderson
Publisher: Informa Healthcare
ISBN: 9781574911060
Category : Business & Economics
Languages : en
Pages : 424

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Book Description
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.

Author: Alan D.T. Barrett
Publisher: Academic Press
ISBN: 0080919022
Category : Science
Languages : en
Pages : 1519

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Book Description
The last 20 years has seen a rapid increase in infectious diseases, particularly those that are termed "emerging diseases" such as SARS, "neglected diseases" such as malaria and those that are deemed biothreats such as anthrax. It is well-recognized that the most effective modality for preventing infectious diseases is vaccination. This book provides researchers with a better understanding of what is currently known about these diseases, including whether there is a vaccine available or under development. It also informs readers of the key issues in development of a vaccine for each disease. Provides a comprehensive treatise of the agents that are responsible for emerging and neglected diseases and those that can be used as biothreats Includes the processes such as the vaccine development pathway, vaccine manufacturing and regulatory issues that are critical to the generation of these vaccines to the marketplace Each chapter will include a map of the world showing where that particular disease is naturally found

Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 1118370392
Category : Science
Languages : en
Pages : 568

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Book Description
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Author: Carmen Medina
Publisher: CRC Press
ISBN: 1135520461
Category : Medical
Languages : en
Pages : 604

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Book Description
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1351593595
Category : Medical
Languages : en
Pages : 574

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Book Description
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines