9780387856261 - handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices (13 resultados)
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Librería: Goodwill of Colorado, COLORADO SPRINGS, CO, Estados Unidos de AmericaGoodwill of Colorado
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Librería: GoldBooks, Denver, CO, Estados Unidos de AmericaGoldBooks
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Buch. Condición: Neu. Druck auf Anfrage Neuware - Printed after ordering - A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENTStability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for co…mmercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is 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. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include:Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.Post-approval considerations and regulatory filing strategies to support a global supply chain. Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).USP-NF testing in support of stability.Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing. Discussion of matrixing and bracketing to support reduced stability testing.Overview of stability programs for biologics and drug-in-devices pharmaceutical products.This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.
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Librería: Books Puddle, New York, NY, Estados Unidos de AmericaBooks Puddle
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EUR 348,59
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Condición: New. pp. 408.
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Librería: Basi6 International, Irving, TX, Estados Unidos de AmericaBasi6 International
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EUR 176,65
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Condición: Brand New. New. US edition. Print on demand title. Delivery takes 20-25 days.
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Librería: Brook Bookstore On Demand, Napoli, NA, ItaliaBrook Bookstore On Demand
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EUR 182,29
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Librería: moluna, Greven, Alemaniamoluna
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EUR 197,62
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Gebunden. Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. This practical handbook is needed in this area to serve pharmaceutical scientists who handle responsibilities in a variety of functions relating to the drug stability, including R&D, formulation, analytic…al development, QA/QC, regulatory affairs and .
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Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, AlemaniaBuchWeltWeit Ludwig Meier e.K.
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EUR 235,39
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Buch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENTStability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory… approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is 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. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include:Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.Post-approval considerations and regulatory filing strategies to support a global supply chain. Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).USP-NF testing in support of stability.Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing. Discussion of matrixing and bracketing to support reduced stability testing.Overview of stability programs for biologics and drug-in-devices pharmaceutical products.This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines. 408 pp. Englisch.
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Librería: buchversandmimpf2000, Emtmannsberg, BAYE, Alemaniabuchversandmimpf2000
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EUR 235,39
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Buch. Condición: Neu. This item is printed on demand - Print on Demand Titel. Neuware -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.- Und…erstanding 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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 408 pp. Englisch.
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Librería: Majestic Books, Hounslow, Reino UnidoMajestic Books
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EUR 368,04
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Condición: New. Print on Demand pp. 408 Illus.
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Librería: Biblios, frankfurt am main, HESSE, AlemaniaBiblios
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EUR 373,66
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Condición: New. PRINT ON DEMAND pp. 408.
