Drug Stability

Author : Thorsteinn Loftsson
Publisher : Academic Press
Page : 170 pages
File Size : 41,6 Mb
Release : 2014-01-25
Category : Medical
ISBN : 9780124115620

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Drug Stability for Pharmaceutical Scientists by Thorsteinn Loftsson Pdf

Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material Provides answers and explanations to test your knowledge Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability

Author : Muhammad Sajid Hamid Akash,Kanwal Rehman
Publisher : Springer Nature
Page : 284 pages
File Size : 42,6 Mb
Release : 2020-11-01
Category : Medical
ISBN : 9789811564260

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Drug Stability and Chemical Kinetics by Muhammad Sajid Hamid Akash,Kanwal Rehman Pdf

This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of reactions, types of degradation and how to prevent it, as well as types of stability studies. It also offers insights into the importance of the rate at which the drug is degraded and/or decomposed under various external and internal conditions, including temperature, pH, humidity and light. This book is intended for researchers, PhD students and scientists working in the field of pharmacy, pharmacology, pharmaceutical chemistry, medicinal chemistry and biopharmaceutics.

Author : Caryn M. Bing
Publisher : Unknown
Page : 0 pages
File Size : 47,8 Mb
Release : 2013
Category : Drug stability
ISBN : 1585283401

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Extended Stability for Parenteral Drugs by Caryn M. Bing Pdf

When caring for patients, medication stability should be the least of your worries. Extended Stability for Parenteral Drugs, Fifth Edition, is the indispensable go-to reference for anyone working in alternate site infusion or preparing sterile compounds. This new edition will help you safely extend beyond-use dating of parenteral medications to minimize waste and reduce costs. What''s New in This Edition? � 160 updated monographs, including 10 new to this edition: o Acetaminophen o Ceftaroline fosamil o Coagulation Factor XIII o Doripenem o Ethanol lock o Ibuprofen o Pantoprazole o Telavancin o Toclizumab o Ziconotide acetate � 24 parenteral nutrition monographs include additional considerations for calcium and phosphate solubility. � Monograph updates include revisions to several container types and new information for elastometric infusion device brands. The Applying Stability Data in Patient Care section now includes a nursing perspective, a primer on the types of vascular access devices used in medication administration, and important considerations for pH, osmolality, concentration, and administration devices. With expanded tables and enhanced references, Extended Stability for Parenteral Drugs, Fifth Edition, is the only publication that brings key stability data on the most commonly used IV solutions, medications, and administration devices, together in one convenient, easy-to-use guide.

Author : Sumie Yoshioka,Valentino J. Stella
Publisher : Springer Science & Business Media
Page : 270 pages
File Size : 48,7 Mb
Release : 2007-05-08
Category : Medical
ISBN : 9780306468292

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Stability of Drugs and Dosage Forms by Sumie Yoshioka,Valentino J. Stella Pdf

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Page : 261 pages
File Size : 44,7 Mb
Release : 2009-12-04
Category : Medical
ISBN : 9781441908896

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Pharmaceutical Stability Testing to Support Global Markets by Kim Huynh-Ba Pdf

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Page : 389 pages
File Size : 55,8 Mb
Release : 2008-11-16
Category : Medical
ISBN : 9780387856278

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Handbook of Stability Testing in Pharmaceutical Development by Kim Huynh-Ba Pdf

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Author : Fenghe Qiu,Garry Scrivens
Publisher : Academic Press
Page : 512 pages
File Size : 43,6 Mb
Release : 2018-06-28
Category : Medical
ISBN : 9780128027851

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Accelerated Predictive Stability (APS) by Fenghe Qiu,Garry Scrivens Pdf

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studies Covers up-to-date regulatory experience

Author : Rodney Pearlman,Y. John Wang
Publisher : Springer Science & Business Media
Page : 432 pages
File Size : 45,5 Mb
Release : 2006-04-11
Category : Medical
ISBN : 9780306474521

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Formulation, Characterization, and Stability of Protein Drugs by Rodney Pearlman,Y. John Wang Pdf

Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Author : Michael Henry Rubinstein
Publisher : Unknown
Page : 178 pages
File Size : 48,6 Mb
Release : 1989
Category : Medical
ISBN : UOM:39015014472198

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Pharmaceutical Technology--drug Stability by Michael Henry Rubinstein Pdf

Author : Christopher T. Rhodes,Jens Thurø Carstensen
Publisher : Unknown
Page : 773 pages
File Size : 41,7 Mb
Release : 2000-01-01
Category : Medical
ISBN : 0585393265

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Drug Stability by Christopher T. Rhodes,Jens Thurø Carstensen Pdf

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.

Author : Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella
Publisher : John Wiley & Sons
Page : 884 pages
File Size : 50,8 Mb
Release : 1986-10-13
Category : Medical
ISBN : 047187955X

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Chemical Stability of Pharmaceuticals by Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella Pdf

Provides a sound theoretical basis for understanding chemical kinetics and its uses in studying drug stability. Treats the calculations, approximations, and estimates that are useful to the pharmacist in professional practice, and presents a collection of selected drug-stability data from the pharmaceutical literature. This Handbook makes accessible to the pharmacist much of the information necessary to make pharmaceutical decisions about drug stability. Changes in this edition include thorough revision of the chapter on oxidation, addition of a new chapter on solid-state stability, and a tripling of the number of stability monographs. All monographs figures have been redrawn, most of them from published data, and all sources are cited.

Author : Sanjay Bajaj,Saranjit Singh
Publisher : Humana
Page : 358 pages
File Size : 48,8 Mb
Release : 2019-06-08
Category : Medical
ISBN : 1493992589

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Methods for Stability Testing of Pharmaceuticals by Sanjay Bajaj,Saranjit Singh Pdf

This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.

Author : Jens T. Carstensen,Christopher Rhodes
Publisher : CRC Press
Page : 792 pages
File Size : 53,9 Mb
Release : 2000-07-28
Category : Medical
ISBN : 0824703766

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Drug Stability, Third Edition, Revised, and Expanded by Jens T. Carstensen,Christopher Rhodes Pdf

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.

Author : Andrew Dickman,Jennifer Schneider
Publisher : Oxford University Press
Page : 609 pages
File Size : 52,6 Mb
Release : 2016
Category : Drug infusion pumps
ISBN : 9780198733720

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The Syringe Driver by Andrew Dickman,Jennifer Schneider Pdf

This text serves as a valuable reference source, providing a comprehensive review of syringe driver use and administration of drugs via CSCI, a safe and effective way of drug administration when other routes are inappropriate.

Author : Jens Thurø Carstensen
Publisher : Unknown
Page : 544 pages
File Size : 46,5 Mb
Release : 1990
Category : Medical
ISBN : UOM:39015018499544

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Drug Stability by Jens Thurø Carstensen Pdf

Practical advice on the problems of carrying out a testing program, written with the stability scientist in mind. Presents basic theory, industrial practice, and regulatory aspects, taking the reader from stability principles of the drug in dissolved, dispersed, and solid states through data analysis of the packaged drug's stability and experimental methods for achieving stable marketed products. Features computer programs, many diagrams and tables, and some 500 references. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com)