Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249
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
Good Laboratory Practice Regulations, Revised and Expanded
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249
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
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249
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
Good Laboratory Practice Regulations, Third Edition, Revised and Expanded
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256
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.
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256
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.
Good Laboratory Practice Regulations
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0849375843
Category : Medical
Languages : en
Pages : 306
Book Description
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Publisher: CRC Press
ISBN: 0849375843
Category : Medical
Languages : en
Pages : 306
Book Description
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Good Laboratory Practice Regulations
Author: Sandy Weinberg
Publisher: CRC Press
ISBN:
Category : Biological laboratories
Languages : en
Pages : 320
Book Description
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.
Publisher: CRC Press
ISBN:
Category : Biological laboratories
Languages : en
Pages : 320
Book Description
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.
Good Laboratory Practice Regulations
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 104016689X
Category : Medical
Languages : en
Pages : 160
Book Description
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Publisher: CRC Press
ISBN: 104016689X
Category : Medical
Languages : en
Pages : 160
Book Description
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Good Laboratory Practice Regulations, Third Edition, Revised and Expanded
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 9781135552534
Category : Medical
Languages : en
Pages : 264
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.
Publisher: CRC Press
ISBN: 9781135552534
Category : Medical
Languages : en
Pages : 264
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.
Clinical Laboratory Animal Medicine
Author: Karen Hrapkiewicz
Publisher: John Wiley & Sons
ISBN: 111834510X
Category : Medical
Languages : en
Pages : 448
Book Description
Clinical Laboratory Animal Medicine: An Introduction, Fourth Edition offers a user-friendly guide to the unique anatomy and physiology, care, common diseases, and treatment of small mammals and nonhuman primates. Carefully designed for ease of use, the book includes tip boxes, images, and review questions to aid in comprehension and learning. The Fourth Edition adds new information on transgenic mice, drug dosages, techniques, and environmental enrichment, making the book a comprehensive working manual for the care and maintenance of common laboratory animals. The book includes information on topics ranging from genetics and behavior to husbandry and techniques in mice, rats, gerbils, hamsters, guinea pigs, chinchillas, rabbits, ferrets, and nonhuman primates. A companion website provides editable review questions and answers, instructional PowerPoints, and additional images not found in the book. Clinical Laboratory Animal Medicine is an invaluable resource for practicing veterinarians, veterinary students, veterinary technicians, and research scientists.
Publisher: John Wiley & Sons
ISBN: 111834510X
Category : Medical
Languages : en
Pages : 448
Book Description
Clinical Laboratory Animal Medicine: An Introduction, Fourth Edition offers a user-friendly guide to the unique anatomy and physiology, care, common diseases, and treatment of small mammals and nonhuman primates. Carefully designed for ease of use, the book includes tip boxes, images, and review questions to aid in comprehension and learning. The Fourth Edition adds new information on transgenic mice, drug dosages, techniques, and environmental enrichment, making the book a comprehensive working manual for the care and maintenance of common laboratory animals. The book includes information on topics ranging from genetics and behavior to husbandry and techniques in mice, rats, gerbils, hamsters, guinea pigs, chinchillas, rabbits, ferrets, and nonhuman primates. A companion website provides editable review questions and answers, instructional PowerPoints, and additional images not found in the book. Clinical Laboratory Animal Medicine is an invaluable resource for practicing veterinarians, veterinary students, veterinary technicians, and research scientists.
Contemporary Practice in Clinical Chemistry
Author: William Clarke
Publisher: Academic Press
ISBN: 0128158336
Category : Science
Languages : en
Pages : 1070
Book Description
Contemporary Practice in Clinical Chemistry, Fourth Edition, provides a clear and concise overview of important topics in the field. This new edition is useful for students, residents and fellows in clinical chemistry and pathology, presenting an introduction and overview of the field to assist readers as they in review and prepare for board certification examinations. For new medical technologists, the book provides context for understanding the clinical utility of tests that they perform or use in other areas in the clinical laboratory. For experienced laboratorians, this revision continues to provide an opportunity for exposure to more recent trends and developments in clinical chemistry. - Includes enhanced illustration and new and revised color figures - Provides improved self-assessment questions and end-of-chapter assessment questions
Publisher: Academic Press
ISBN: 0128158336
Category : Science
Languages : en
Pages : 1070
Book Description
Contemporary Practice in Clinical Chemistry, Fourth Edition, provides a clear and concise overview of important topics in the field. This new edition is useful for students, residents and fellows in clinical chemistry and pathology, presenting an introduction and overview of the field to assist readers as they in review and prepare for board certification examinations. For new medical technologists, the book provides context for understanding the clinical utility of tests that they perform or use in other areas in the clinical laboratory. For experienced laboratorians, this revision continues to provide an opportunity for exposure to more recent trends and developments in clinical chemistry. - Includes enhanced illustration and new and revised color figures - Provides improved self-assessment questions and end-of-chapter assessment questions
Guidebook for Drug Regulatory Submissions
Author: Sandy Weinberg
Publisher: John Wiley & Sons
ISBN: 0470456175
Category : Medical
Languages : en
Pages : 392
Book Description
Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guideāit is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.
Publisher: John Wiley & Sons
ISBN: 0470456175
Category : Medical
Languages : en
Pages : 392
Book Description
Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guideāit is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.
Basic QC Practices, 4th Edition
Author: James O. Westgard
Publisher:
ISBN: 9781886958302
Category :
Languages : en
Pages : 290
Book Description
Publisher:
ISBN: 9781886958302
Category :
Languages : en
Pages : 290
Book Description