9780387856261 - handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices (12 risultati)
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Da: Goodwill of Colorado, COLORADO SPRINGS, CO, U.S.A.Goodwill of Colorado
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Condizione: very_good. Item may have minor cosmetic defects marks, wears, cuts, bends, crushes on the cover, spine, pages or dust cover. Shrink wrap, dust covers, or boxed set case may be missing. Item may contain remainder marks on outside edges, which should be noted in Product Details. Item may be missing bundled media.
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Da: Reuseabook, Gloucester, GLOS, Regno UnitoReuseabook
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EUR 104,24
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hardcover. Condizione: Used; Very Good. Dispatched, from the UK, within 48 hours of ordering. Though second-hand, the book is still in very good shape. Minimal signs of usage may include very minor creasing on the cover or on the spine.
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Da: GoldBooks, Denver, CO, U.S.A.GoldBooks
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EUR 148,37
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Hardcover. Condizione: new. New Copy. Customer Service Guaranteed.
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Da: Ria Christie Collections, Uxbridge, Regno UnitoRia Christie Collections
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EUR 226,60
EUR 13,94 spedizioneSpedito da Regno Unito a U.S.A.Quantità: Più di 20 disponibili
Condizione: New. In.
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Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH
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EUR 235,39
EUR 64,25 spedizioneSpedito da Germania a U.S.A.Quantità: 1 disponibili
Buch. Condizione: 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 c…ommercialization. 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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Da: Books Puddle, New York, NY, U.S.A.Books Puddle
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EUR 313,33
EUR 3,44 spedizioneSpedito in U.S.A.Quantità: 4 disponibili
Condizione: New. pp. 408.
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Da: Brook Bookstore On Demand, Napoli, NA, ItaliaBrook Bookstore On Demand
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EUR 182,29
EUR 13,50 spedizioneSpedito da Italia a U.S.A.Quantità: Più di 20 disponibili
Condizione: new. Questo è un articolo print on demand.
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Da: moluna, Greven, Germaniamoluna
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EUR 197,62
EUR 48,99 spedizioneSpedito da Germania a U.S.A.Quantità: Più di 20 disponibili
Gebunden. Condizione: 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, analyti…cal development, QA/QC, regulatory affairs and .
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Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermaniaBuchWeltWeit Ludwig Meier e.K.
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EUR 235,39
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Buch. Condizione: 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 regulator…y 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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Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germaniabuchversandmimpf2000
Contatta il venditoreVenditore con 5 stelleCondizione: Nuovo
EUR 235,39
EUR 60,00 spedizioneSpedito da Germania a U.S.A.Quantità: 1 disponibili
Buch. Condizione: 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.- Un…derstanding 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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Da: Majestic Books, Hounslow, Regno UnitoMajestic Books
Contatta il venditoreVenditore con 4 stelleCondizione: Nuovo
EUR 326,28
EUR 7,56 spedizioneSpedito da Regno Unito a U.S.A.Quantità: 4 disponibili
Condizione: New. Print on Demand pp. 408 Illus.
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Da: Biblios, frankfurt am main, HESSE, GermaniaBiblios
Contatta il venditoreVenditore con 4 stelleCondizione: Nuovo
EUR 334,99
EUR 9,95 spedizioneSpedito da Germania a U.S.A.Quantità: 4 disponibili
Condizione: New. PRINT ON DEMAND pp. 408.
