Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.
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Inside This Book
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First Sentence:
Everything made by human hands-from the sublime Parthenon to the trivial milkshake-is subject to decay. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
registration batches, minimum shelf lives, matrixing design, approved stability protocol, final packaging material, ongoing stability testing, chemistry review team, tentative expiration dating period, drug product batches, reduced stability testing, stability information systems, approved expiration dating period, conformance period, kinetic mean temperature, photostability characteristics, bracketing design, stability overage, stability test protocol, open expiration date, supportive stability data, assumed degradation line, formal stability program, pharmaceutical product type, supplemental changes, original shelf life Key Phrases - Capitalized Phrases (CAPs): (learn more)
Storage Storage, Carstensen Fig, New York, Drug Dev, United States, Pharm Res, Pharm Sci, International Conference, European Union, Reviewer Guidance, Atlas Suntest, Marcel Dekker, University of Wisconsin, Academic Press, School of Pharmacy, John Wiley, Expert Report, Pharm Tech, Test Batch, Biol Chem, Drugs Made, Experimental Standard, Testing Batch, Van Campen, Wissenschaftliche Verlagsgesellschaft New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Everything made by human hands-from the sublime Parthenon to the trivial milkshake-is subject to decay. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
registration batches, minimum shelf lives, matrixing design, approved stability protocol, final packaging material, ongoing stability testing, chemistry review team, tentative expiration dating period, drug product batches, reduced stability testing, stability information systems, approved expiration dating period, conformance period, kinetic mean temperature, photostability characteristics, bracketing design, stability overage, stability test protocol, open expiration date, supportive stability data, assumed degradation line, formal stability program, pharmaceutical product type, supplemental changes, original shelf life Key Phrases - Capitalized Phrases (CAPs): (learn more)
Storage Storage, Carstensen Fig, New York, Drug Dev, United States, Pharm Res, Pharm Sci, International Conference, European Union, Reviewer Guidance, Atlas Suntest, Marcel Dekker, University of Wisconsin, Academic Press, School of Pharmacy, John Wiley, Expert Report, Pharm Tech, Test Batch, Biol Chem, Drugs Made, Experimental Standard, Testing Batch, Van Campen, Wissenschaftliche Verlagsgesellschaft New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 90
books:
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80
books
cite this book:
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- Modern Pharmaceutics by Gilbert S. Banker on 5 pages
- Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Sciences Series, Vol 78) by Sidney H. Willig in Front Matter (1), Front Matter (2), and Front Matter (3)
- New Drug Approval Process, Fourth Edition, Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) by Richard Guarino in Front Matter (1), Front Matter (2), and Front Matter (3)
- Pharmaceutics of Solids and Solid Dosage Forms by Jens Thuro Carstensen on page 207, and page 259
- Principles of Physical Chemistry by S Maron on page 109, and page 188
See all 90 books this book cites
- Preparing for FDA Pre-Approval Inspections (Drugs & the Pharmaceutical Sciences) (Drugs and the Pharmaceutical Sciences) by Hynes on 4 pages
- Pharmaceutical Process Scale-Up (Drugs and the Pharmaceutical Sciences) by Michael Levin on 4 pages
- The Clinical Audit in Pharmaceutical Development (Drugs and the Pharmaceutical Sciences) by Michael Hamrell in Front Matter (1), Front Matter (2), and Front Matter (3)
- Drug Products for Clinical Trials, Second Edition (Drugs and the Pharmaceutical Sciences) by Donald Monkhouse in Front Matter (1), Front Matter (2), and Front Matter (3)
- Excipient Toxicity and Safety (Drugs and the Pharmaceutical Sciences) by Weiner/KotKosKi in Front Matter (1), Front Matter (2), and Front Matter (3)
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