Drug Stability For Pharmaceutical Scientists

Download Drug Stability For Pharmaceutical Scientists full books in PDF, epub, and Kindle. Read online Drug Stability For Pharmaceutical Scientists ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Drug Stability for Pharmaceutical Scientists

Author : Thorsteinn Loftsson
Publisher : Academic Press
ISBN 13 : 0124115624
Total Pages : 170 pages
Book Rating : 4.1/5 (241 download)

DOWNLOAD NOW!

Book Synopsis Drug Stability for Pharmaceutical Scientists by : Thorsteinn Loftsson

Download or read book Drug Stability for Pharmaceutical Scientists written by Thorsteinn Loftsson and published by Academic Press. This book was released on 2014-01-25 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Pharmaceutical Stability Testing to Support Global Markets

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 1441908897
Total Pages : 261 pages
Book Rating : 4.4/5 (419 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Stability Testing to Support Global Markets by : Kim Huynh-Ba

Download or read book Pharmaceutical Stability Testing to Support Global Markets written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2009-12-04 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Drug Stability

Author : Jens Thurø Carstensen
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 624 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis Drug Stability by : Jens Thurø Carstensen

Download or read book Drug Stability written by Jens Thurø Carstensen and published by Marcel Dekker. This book was released on 1995 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combining basic theory, current industrial practice, and useful regulatory aspects in an original overview of pharmaceutical stability, this thoroughly rewritten and enlarged reference/text examines data analysis of the packaged drug's stability, experimental methods for achieving stable marketed products, and the stability principles of drugs in dissolved, dispersed, and solid states.

Drug Stability, Third Edition, Revised, and Expanded

Author : Jens T. Carstensen
Publisher : CRC Press
ISBN 13 : 9780824703769
Total Pages : 792 pages
Book Rating : 4.7/5 (37 download)

DOWNLOAD NOW!

Book Synopsis Drug Stability, Third Edition, Revised, and Expanded by : Jens T. Carstensen

Download or read book Drug Stability, Third Edition, Revised, and Expanded written by Jens T. Carstensen and published by CRC Press. This book was released on 2000-07-28 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Chemical Stability of Pharmaceuticals

Author : Kenneth A. Connors
Publisher : John Wiley & Sons
ISBN 13 : 047187955X
Total Pages : 869 pages
Book Rating : 4.4/5 (718 download)

DOWNLOAD NOW!

Book Synopsis Chemical Stability of Pharmaceuticals by : Kenneth A. Connors

Download or read book Chemical Stability of Pharmaceuticals written by Kenneth A. Connors and published by John Wiley & Sons. This book was released on 1986-10-13 with total page 869 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Drug Stability and Chemical Kinetics

Author : Muhammad Sajid Hamid Akash
Publisher : Springer Nature
ISBN 13 : 9811564264
Total Pages : 284 pages
Book Rating : 4.8/5 (115 download)

DOWNLOAD NOW!

Book Synopsis Drug Stability and Chemical Kinetics by : Muhammad Sajid Hamid Akash

Download or read book Drug Stability and Chemical Kinetics written by Muhammad Sajid Hamid Akash and published by Springer Nature. This book was released on 2020-11-01 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Accelerated Predictive Stability (APS)

Author : Fenghe Qiu
Publisher : Academic Press
ISBN 13 : 0128027851
Total Pages : 512 pages
Book Rating : 4.1/5 (28 download)

DOWNLOAD NOW!

Book Synopsis Accelerated Predictive Stability (APS) by : Fenghe Qiu

Download or read book Accelerated Predictive Stability (APS) written by Fenghe Qiu and published by Academic Press. This book was released on 2018-06-28 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Handbook of Stability Testing in Pharmaceutical Development

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)

DOWNLOAD NOW!

Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

An Introduction to Pharmaceutical Sciences

Author : Jiben Roy
Publisher : Elsevier
ISBN 13 : 1908818042
Total Pages : 449 pages
Book Rating : 4.9/5 (88 download)

DOWNLOAD NOW!

Book Synopsis An Introduction to Pharmaceutical Sciences by : Jiben Roy

Download or read book An Introduction to Pharmaceutical Sciences written by Jiben Roy and published by Elsevier. This book was released on 2011-07-25 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

Drug Stability

Author : Christopher T. Rhodes
Publisher :
ISBN 13 : 9780585393261
Total Pages : 773 pages
Book Rating : 4.3/5 (932 download)

DOWNLOAD NOW!

Book Synopsis Drug Stability by : Christopher T. Rhodes

Download or read book Drug Stability written by Christopher T. Rhodes and published by . This book was released on 2000-01-01 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Lipid Nanoparticles: Production, Characterization and Stability

Author : Rohan Shah
Publisher : Springer
ISBN 13 : 3319107119
Total Pages : 97 pages
Book Rating : 4.3/5 (191 download)

DOWNLOAD NOW!

Book Synopsis Lipid Nanoparticles: Production, Characterization and Stability by : Rohan Shah

Download or read book Lipid Nanoparticles: Production, Characterization and Stability written by Rohan Shah and published by Springer. This book was released on 2014-08-28 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: What are lipid nanoparticles? How are they structured? How are they formed? What techniques are best to characterize them? How great is their potential as drug delivery systems? These questions and more are answered in this comprehensive and highly readable work on lipid nanoparticles. This work sets out to provide the reader with a clear and understandable understanding of the current practices in formulation, characterization and drug delivery of lipid nanoparticles. A comprehensive description of the current understanding of synthesis, characterization, stability optimization and drug incorporation of solid lipid nanoparticles is provided. Nanoparticles have attracted great interest over the past few decades with almost exponential growth in their research and application. Their small particle size and subsequent high surface area make them ideal in many uses, but particularly as drug carrier systems. Nanoparticles made from lipids are especially attractive because of their enhanced biocompatibility imparted by the lipid. The work provides a detailed description of the types of lipid nanoparticles available (e.g. SLN, NLC, LDC, PLN) and how they range from imperfect crystalline to amorphous in structure. Current thoughts on where drugs are situated (e.g. in the core, or at the interface) and how this can be manipulated are discussed. The many techniques for production, including the author’s own variant of microwave heating, are fully discussed. Techniques for measuring arguably the most important characteristics of particle size and polydispersity are discussed, along with techniques to measure crystallinity, shape and drug capacity. Finally, a full chapter on techniques for measuring stability, both in the absence and presence of drugs, is discussed, along with suggestions on how to optimize that stability. This work appeals to students of colloid science, practitioners of research into drug delivery and academics alike.

Drug Stability

Author : Jens Thurø Carstensen
Publisher :
ISBN 13 :
Total Pages : 544 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis Drug Stability by : Jens Thurø Carstensen

Download or read book Drug Stability written by Jens Thurø Carstensen and published by . This book was released on 1990 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

Pharmaceutical Formulation

Author : Geoffrey D Tovey
Publisher : Royal Society of Chemistry
ISBN 13 : 1849739412
Total Pages : 432 pages
Book Rating : 4.8/5 (497 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Formulation by : Geoffrey D Tovey

Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

Stability of Drugs and Dosage Forms

Author : Sumie Yoshioka
Publisher : Springer Science & Business Media
ISBN 13 : 0306468298
Total Pages : 270 pages
Book Rating : 4.3/5 (64 download)

DOWNLOAD NOW!

Book Synopsis Stability of Drugs and Dosage Forms by : Sumie Yoshioka

Download or read book Stability of Drugs and Dosage Forms written by Sumie Yoshioka and published by Springer Science & Business Media. This book was released on 2007-05-08 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Statistical Design and Analysis in Pharmaceutical Science

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1482273136
Total Pages : 581 pages
Book Rating : 4.4/5 (822 download)

DOWNLOAD NOW!

Book Synopsis Statistical Design and Analysis in Pharmaceutical Science by : Shein-Chung Chow

Download or read book Statistical Design and Analysis in Pharmaceutical Science written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-10-03 with total page 581 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
Publisher : CRC Press
ISBN 13 : 9781439801796
Total Pages : 0 pages
Book Rating : 4.8/5 (17 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Stress Testing by : Steven W. Baertschi

Download or read book Pharmaceutical Stress Testing written by Steven W. Baertschi and published by CRC Press. This book was released on 2011-07-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
Publisher : CRC Press
ISBN 13 : 9780824740214
Total Pages : 504 pages
Book Rating : 4.7/5 (42 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Stress Testing by : Steven W. Baertschi

Download or read book Pharmaceutical Stress Testing written by Steven W. Baertschi and published by CRC Press. This book was released on 2005-06-24 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.