Handbook of Stability Testing in Pharmaceutical Development : Regulations, Methodologies, and Best Practices

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Handbook of Stability Testing in Pharmaceutical Development : Regulations, Methodologies, and Best Practices

Huynh-Ba, K. (EDT)

ウェブストア価格 ¥45,841（本体¥41,674）
Springer（2008/12発売）
外貨定価 US$ 219.99
ポイント 416pt

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製本 Hardcover:ハードカバー版／ページ数 389 p.／サイズ 72 illus.
商品コード 9780387856261

基本説明

The first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices.

Full Description

In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue. The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations,a knowledgeof science, a graspof compliance,and an appreciation of common practices. Sinceearly2000,Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums. As a book lover, I also have a good collection of technical books. Unfor- nately, most of the stability related volumes are outdated. Many of these materials are theoretical and do not contain much practical information.
I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththepharmac- tical industryto accommodatethese changes;however,thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice. Therefore, I hoped to ass- ble a practical handbook to ?ll this void.

Stability Regulations.- Critical Regulatory Requirements for a Stability Program.- Understanding ICH Guidelines Applicable to Stability Testing.- Global Stability Practices.- Post-approval Changes - Stability Requirements and Regulations.- Understanding and Predicting Pharmaceutical Product Shelf-Life.- Stability Methodologies and Best Practices.- Development of Stability Indicating Methods.- Method Validation and Transfer.- Overview of USP-NF Requirements for Stability Purposes.- Non-chromatographic Methods to Support Stability Program.- Vibrational Spectroscopic Methods for Quantitative Analysis.- Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product.- Evaluation of Stability Data.- Qualification, Calibration, and Maintenance of Stability Chambers.- Stability Operation Practices.- Other Stability Programs.- Combination Products/Drugs in Devices.- Stability Studies for Biologics.