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.
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Editorial Reviews
Review
" ....Peterson's chapter is worth the price of the book." -- Journal of Pharmaceutical and Biomedical Analysis
"...very valuable for all laboratories working with assays in drug and environmental analysis." -- European Journal of Pharmaceutics and Biopharmaceutics
"The editor has produced a well-integrated book on an important topic." -- Journal of Pharmacy and Pharmacology
"This second edition of Good Laboratory Practice Regulations is comprehensive in its presentation." -- Cosmetics & Toiletries
"...very valuable for all laboratories working with assays in drug and environmental analysis." -- European Journal of Pharmaceutics and Biopharmaceutics
"The editor has produced a well-integrated book on an important topic." -- Journal of Pharmacy and Pharmacology
"This second edition of Good Laboratory Practice Regulations is comprehensive in its presentation." -- Cosmetics & Toiletries
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First Sentence:
The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
nonclinical laboratory study, nonclinical laboratory studies, master schedule sheet, marketing permit, automated data collection systems, quality assurance unit, control articles, laboratory practice standards, good laboratory practice regulations, amendments statement, study director, contract lab, record retention requirements, centralized laboratories, test article, laboratory information management systems, automated laboratory, regulatory acceptance, testing facility, laboratory management, surveillance inspection, system validation Key Phrases - Capitalized Phrases (CAPs): (learn more)
Environmental Protection Agency, Fed Reg, United States, Federal Register, Department of Health, Federal Food, Code of Federal Regulations, Department of Agriculture, Federal Insecticide, Muhlenberg College, Public Health Service Act, Freedom of Information Act, Paul Lepore, Toxic Substances Control Act New!
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Front Cover | Table of Contents | First Pages | Index | Surprise Me!
The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
nonclinical laboratory study, nonclinical laboratory studies, master schedule sheet, marketing permit, automated data collection systems, quality assurance unit, control articles, laboratory practice standards, good laboratory practice regulations, amendments statement, study director, contract lab, record retention requirements, centralized laboratories, test article, laboratory information management systems, automated laboratory, regulatory acceptance, testing facility, laboratory management, surveillance inspection, system validation Key Phrases - Capitalized Phrases (CAPs): (learn more)
Environmental Protection Agency, Fed Reg, United States, Federal Register, Department of Health, Federal Food, Code of Federal Regulations, Department of Agriculture, Federal Insecticide, Muhlenberg College, Public Health Service Act, Freedom of Information Act, Paul Lepore, Toxic Substances Control Act New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
Citations (learn more)
This book cites 100
books:
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68
books
cite this book:
See all 68 books citing this book
- Modern Pharmaceutics by Gilbert S. Banker on 4 pages
- Pharmaceutical Process Validation: An International Third Edition (Drugs and the Pharmaceutical Sciences) by Robert A. Nash in Front Matter (1), Front Matter (2), and Front Matter (3)
- Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms (Drugs and the Pharmaceutical Sciences) by James McGinity in Front Matter (1), and Front Matter (2)
- Clinical Drug Trials and Tribulations, Second Edition, (Drugs and the Pharmaceutical Sciences) by Cato in Front Matter (1), and Front Matter (2)
- Novel Drug Delivery Systems (Drugs and the Pharmaceutical Sciences) by Yie Chien in Front Matter (1), and Front Matter (2)
See all 100 books this book cites
- Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Drugs and the Pharmaceutical Sciences) by Carmen Medina in Front Matter (1), Front Matter (2), and page 80
- Spectroscopy of Pharmaceutical Solids (Drugs and the Pharmaceutical Sciences) by Harry G. Brittain in Front Matter (1), and Front Matter (2)
- New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics (Drugs and the Pharmaceutical Sciences) by Chandrahas Sahajwalla in Front Matter (1), and Front Matter (2)
- Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Patkage Integrity Testing: Third Edition, (Drugs and the Pharmaceutical Sciences) by Michael K. Akers in Front Matter (1), and Front Matter (2)
- Supercritical Fluid Technology for Drug Product Development (Drugs and the Pharmaceutical Sciences) (Vol 138) by Peter York in Front Matter (1), and Front Matter (2)
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