Drug Stability for Pharmaceutical Scientists

Drug Stability for Pharmaceutical Scientists
Author: Thorsteinn Loftsson
Publsiher: Academic Press
Total Pages: 170
Release: 2014-01-25
ISBN 10: 0124115624
ISBN 13: 9780124115620
Language: EN, FR, DE, ES & NL

Drug Stability for Pharmaceutical Scientists Book Review:

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 Stress Testing

Pharmaceutical Stress Testing
Author: Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
Publsiher: CRC Press
Total Pages: 612
Release: 2016-04-19
ISBN 10: 1439801800
ISBN 13: 9781439801802
Language: EN, FR, DE, ES & NL

Pharmaceutical Stress Testing Book Review:

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).

Drug Stability and Chemical Kinetics

Drug Stability and Chemical Kinetics
Author: Muhammad Sajid Hamid Akash,Kanwal Rehman
Publsiher: Springer Nature
Total Pages: 284
Release: 2020-11-01
ISBN 10: 9811564264
ISBN 13: 9789811564260
Language: EN, FR, DE, ES & NL

Drug Stability and Chemical Kinetics Book Review:

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.

Drug Stability

Drug Stability
Author: Christopher T. Rhodes,Jens Thurø Carstensen
Publsiher: Unknown
Total Pages: 773
Release: 2000-01-01
ISBN 10: 9780585393261
ISBN 13: 0585393265
Language: EN, FR, DE, ES & NL

Drug Stability Book Review:

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.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Author: Kim Huynh-Ba
Publsiher: Springer Science & Business Media
Total Pages: 389
Release: 2008-11-16
ISBN 10: 0387856277
ISBN 13: 9780387856278
Language: EN, FR, DE, ES & NL

Handbook of Stability Testing in Pharmaceutical Development Book Review:

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.

Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets
Author: Kim Huynh-Ba
Publsiher: Springer Science & Business Media
Total Pages: 266
Release: 2009-12-04
ISBN 10: 9781441908896
ISBN 13: 1441908897
Language: EN, FR, DE, ES & NL

Pharmaceutical Stability Testing to Support Global Markets Book Review:

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.

An Introduction to Pharmaceutical Sciences

An Introduction to Pharmaceutical Sciences
Author: Jiben Roy
Publsiher: Elsevier
Total Pages: 446
Release: 2011-07-25
ISBN 10: 1908818042
ISBN 13: 9781908818041
Language: EN, FR, DE, ES & NL

An Introduction to Pharmaceutical Sciences Book Review:

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

Analytical Techniques in the Pharmaceutical Sciences

Analytical Techniques in the Pharmaceutical Sciences
Author: Anette Müllertz,Yvonne Perrie,Thomas Rades
Publsiher: Springer
Total Pages: 838
Release: 2016-08-30
ISBN 10: 1493940295
ISBN 13: 9781493940295
Language: EN, FR, DE, ES & NL

Analytical Techniques in the Pharmaceutical Sciences Book Review:

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Drug Stability

Drug Stability
Author: Jens Thurø Carstensen
Publsiher: Marcel Dekker Incorporated
Total Pages: 520
Release: 1990
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015018499544
Language: EN, FR, DE, ES & NL

Drug Stability Book Review:

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)

Drug Stability Third Edition Revised and Expanded

Drug Stability  Third Edition  Revised  and Expanded
Author: Jens T. Carstensen,Christopher Rhodes
Publsiher: CRC Press
Total Pages: 792
Release: 2000-07-28
ISBN 10: 9780824703769
ISBN 13: 0824703766
Language: EN, FR, DE, ES & NL

Drug Stability Third Edition Revised and Expanded Book Review:

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

Chemical Stability of Pharmaceuticals
Author: Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella
Publsiher: John Wiley & Sons
Total Pages: 864
Release: 1986-10-13
ISBN 10: 9780471879558
ISBN 13: 047187955X
Language: EN, FR, DE, ES & NL

Chemical Stability of Pharmaceuticals Book Review:

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.

Integrated Pharmaceutics

Integrated Pharmaceutics
Author: Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Publsiher: John Wiley & Sons
Total Pages: 1016
Release: 2013-01-22
ISBN 10: 1118356721
ISBN 13: 9781118356722
Language: EN, FR, DE, ES & NL

Integrated Pharmaceutics Book Review:

Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Accelerated Predictive Stability APS

Accelerated Predictive Stability  APS
Author: Fenghe Qiu,Garry Scrivens
Publsiher: Academic Press
Total Pages: 512
Release: 2018-06-28
ISBN 10: 0128027851
ISBN 13: 9780128027851
Language: EN, FR, DE, ES & NL

Accelerated Predictive Stability APS Book Review:

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

Stability indicating HPLC Methods for Drug Analysis

Stability indicating HPLC Methods for Drug Analysis
Author: Quanyun A. Xu,Lawrence A. Trissel,American Pharmacists Association
Publsiher: Amer Pharmacists Assn
Total Pages: 690
Release: 2003
ISBN 10: 9781582120461
ISBN 13: 1582120463
Language: EN, FR, DE, ES & NL

Stability indicating HPLC Methods for Drug Analysis Book Review:

Stability-Indicating HPLC Methods for Drug Analysis compiles summaries of stability-indicating HPLC analytical methods that have appeared in the published literature. A first stop for pharmaceutical scientists, analytical chemists, and librarians in the quest for information about the stability of drugs. Co-published by the American Pharmaceutical Association and the Pharmaceutical Press, a division of the Royal Pharmaceutical Society of Great Britain.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publsiher: Academic Press
Total Pages: 1176
Release: 2016-11-08
ISBN 10: 0128026375
ISBN 13: 9780128026373
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Integration of Pharmaceutical Discovery and Development

Integration of Pharmaceutical Discovery and Development
Author: Ronald T. Borchardt,Roger M. Freidinger,Tomi K. Sawyer,Philip L. Smith
Publsiher: Springer Science & Business Media
Total Pages: 610
Release: 2006-04-11
ISBN 10: 0306473844
ISBN 13: 9780306473845
Language: EN, FR, DE, ES & NL

Integration of Pharmaceutical Discovery and Development Book Review:

In the late 1980s, it became painfully evident to the pharmaceutical industry that the old paradigm of drug discovery, which involved highly segmented drug - sign and development activities, would not produce an acceptable success rate in the future. Therefore, in the early 1990s a paradigm shift occurred in which drug design and development activities became more highly integrated. This new str- egy required medicinal chemists to design drug candidates with structural f- tures that optimized pharmacological (e. g. , high affinity and specificity for the target receptor), pharmaceutical (e. g. , solubility and chemical stability), bioph- maceutical (e. g. , cell membrane permeability), and metabolic/pharmacokinetic (e. g. , metabolic stability, clearance, and protein binding) properties. Successful implementation of this strategy requires a multidisciplinary team effort, incl- ing scientists from drug design (e. g. , medicinal chemists, cell biologists, en- mologists, pharmacologists) and drug development (e. g. , analytical chemists, pharmaceutical scientists, physiologists, and molecular biologists representing the disciplines of pharmaceutics, biopharmaceutics, and pharmacokinetics/drug metabolism). With this new, highly integrated approach to drug design now widely utilized by the pharmaceutical industry, the editors of this book have provided the sci- tific community with case histories to illustrate the nature of the interdisciplinary interactions necessary to successfully implement this new approach to drug d- covery. In the first chapter, Ralph Hirschmann provides a historical perspective of why this paradigm shift in drug discovery has occurred.

Pharmaceutical Technology

Pharmaceutical Technology
Author: Michael Henry Rubinstein
Publsiher: Ellis Horwood Limited
Total Pages: 419
Release: 1989-01-01
ISBN 10: 9780136628422
ISBN 13: 0136628427
Language: EN, FR, DE, ES & NL

Pharmaceutical Technology Book Review:

The problem of producing drugs with a high level of stability is the subject of this volume, which is part of a series designed to reflect new advances in pharmaceutical chemical discoveries. It contains a series of essays by international researchers who present a range of topical issues.

Pharmaceutical Crystals

Pharmaceutical Crystals
Author: Tonglei Li,Alessandra Mattei
Publsiher: John Wiley & Sons
Total Pages: 528
Release: 2018-10-16
ISBN 10: 1119046297
ISBN 13: 9781119046295
Language: EN, FR, DE, ES & NL

Pharmaceutical Crystals Book Review:

An important resource that puts the focus on understanding and handling of organic crystals in drug development Since a majority of pharmaceutical solid-state materials are organic crystals, their handling and processing are critical aspects of drug development. Pharmaceutical Crystals: Science and Engineering offers an introduction to and thorough coverage of organic crystals, and explores the essential role they play in drug development and manufacturing. Written contributions from leading researchers and practitioners in the field, this vital resource provides the fundamental knowledge and explains the connection between pharmaceutically relevant properties and the structure of a crystal. Comprehensive in scope, the text covers a range of topics including: crystallization, molecular interactions, polymorphism, analytical methods, processing, and chemical stability. The authors clearly show how to find solutions for pharmaceutical form selection and crystallization processes. Designed to be an accessible guide, this book represents a valuable resource for improving the drug development process of small drug molecules. This important text: Includes the most important aspects of solid-state organic chemistry and its role in drug development Offers solutions for pharmaceutical form selection and crystallization processes Contains a balance between the scientific fundamental and pharmaceutical applications Presents coverage of crystallography, molecular interactions, polymorphism, analytical methods, processing, and chemical stability Written for both practicing pharmaceutical scientists, engineers, and senior undergraduate and graduate students studying pharmaceutical solid-state materials, Pharmaceutical Crystals: Science and Engineering is a reference and textbook for understanding, producing, analyzing, and designing organic crystals which is an imperative skill to master for anyone working in the field.

HPLC for Pharmaceutical Scientists

HPLC for Pharmaceutical Scientists
Author: Yuri V. Kazakevich,Rosario LoBrutto
Publsiher: John Wiley & Sons
Total Pages: 1080
Release: 2007-02-16
ISBN 10: 0470087943
ISBN 13: 9780470087947
Language: EN, FR, DE, ES & NL

HPLC for Pharmaceutical Scientists Book Review:

HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publsiher: Academic Press
Total Pages: 978
Release: 2009-03-10
ISBN 10: 9780080932729
ISBN 13: 008093272X
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies