Handbook Stability Testing Pharmaceutical (27 results)
- Softcover
- International Edition
Seller: Romtrade Corp., STERLING HEIGHTS, MI, U.S.A.Romtrade Corp.
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Condition: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be print…ed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.
- Softcover
- International Edition
Seller: Basi6 International, Irving, TX, U.S.A.Basi6 International
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Condition: Brand New. New.SoftCover International edition. Different ISBN and Cover image but contents are same as US edition.Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service.
- Softcover
Seller: SMASS Sellers, IRVING, TX, U.S.A.SMASS Sellers
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Condition: New. Brand New, Softcover edition. This item may ship from the US or our Overseas warehouse depending on your location and stock availability.
- Hardcover
Seller: Goodwill of Colorado, COLORADO SPRINGS, CO, U.S.A.Goodwill of Colorado
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Condition: good. All pages and cover are intact. Dust jacket included if applicable, though it may be missing on hardcover editions. Spine and cover may show minor signs of wear including scuff marks, curls or bends to corners as well as cosmetic blemishes including stickers. Pages may contain limited notes or highlighting. "Fro…m the library of" labels may be present. Shrink wrap, dust covers, or boxed set packaging may be missing. Bundled media e.g., CDs, DVDs, access codes may not be included.
- Hardcover
Seller: Reuseabook, Gloucester, GLOS, United KingdomReuseabook
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US$ 134.62
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hardcover. Condition: 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.
- Hardcover
Seller: GoldBooks, Denver, CO, U.S.A.GoldBooks
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Hardcover. Condition: new. New Copy. Customer Service Guaranteed.
- Softcover
Seller: Oblivion Books, Seattle, WA, U.S.A.Oblivion Books
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paperback. Condition: Very Good. Softcover. Clean text - NO writing, NO highlighting. Very good.
- Hardcover
Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
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Condition: New. In.
- Softcover
Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
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Condition: New. In.
- Softcover
Seller: preigu, Osnabrück, Germanypreigu
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US$ 238.52
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Taschenbuch. Condition: Neu. Handbook of Stability Testing in Pharmaceutical Development | Regulations, Methodologies, and Best Practices | Kim Huynh-Ba | Taschenbuch | xvii | Englisch | 2010 | Humana | EAN 9781441927569 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]h…artmann[at]springer[dot]com | Anbieter: preigu.
- Softcover
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
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US$ 276.77
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Taschenbuch. Condition: 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 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.
- Softcover
Seller: Books Puddle, New York, NY, U.S.A.Books Puddle
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US$ 346.29
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Condition: New. pp. 408.
- Hardcover
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
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US$ 287.92
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Buch. Condition: 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.
- Hardcover
Seller: Books Puddle, New York, NY, U.S.A.Books Puddle
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US$ 386.74
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Condition: New. pp. 408.
- Hardcover
- Print on Demand
Seller: Basi6 International, Irving, TX, U.S.A.Basi6 International
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US$ 195.98
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Condition: Brand New. New. US edition. Print on demand title. Delivery takes 20-25 days.
- Softcover
- Print on Demand
Seller: Brook Bookstore On Demand, Napoli, NA, ItalyBrook Bookstore On Demand
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Condition: new. Questo è un articolo print on demand.
- Hardcover
- Print on Demand
Seller: Brook Bookstore On Demand, Napoli, NA, ItalyBrook Bookstore On Demand
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Condition: new. Questo è un articolo print on demand.
- Softcover
- Print on Demand
Seller: moluna, Greven, Germanymoluna
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US$ 232.37
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Condition: 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, analytical develop…ment, QA/QC, regulatory affairs and .
- Hardcover
- Print on Demand
Seller: moluna, Greven, Germanymoluna
Contact seller5-star sellerCondition: New
US$ 232.37
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Gebunden. Condition: 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 .
- Softcover
- Print on Demand
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.
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US$ 276.77
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Taschenbuch. Condition: 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 reg…ulatory 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.
- Hardcover
- Print on Demand
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.
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US$ 276.77
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Buch. Condition: 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.
- Hardcover
- Print on Demand
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germanybuchversandmimpf2000
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Buch. Condition: 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.
- Softcover
- Print on Demand
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germanybuchversandmimpf2000
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US$ 276.77
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Taschenbuch. Condition: 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 Regulation…s.- 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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 408 pp. Englisch.
- Softcover
- Print on Demand
Seller: Majestic Books, Hounslow, United KingdomMajestic Books
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Condition: New. Print on Demand pp. 408 72 Illus.
- Softcover
- Print on Demand
Seller: Biblios, frankfurt am main, HESSE, GermanyBiblios
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Condition: New. PRINT ON DEMAND pp. 408.
- Hardcover
- Print on Demand
Seller: Majestic Books, Hounslow, United KingdomMajestic Books
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Condition: New. Print on Demand pp. 408 Illus.
- Hardcover
- Print on Demand
Seller: Biblios, frankfurt am main, HESSE, GermanyBiblios
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Condition: New. PRINT ON DEMAND pp. 408.
