Download Drug Stability For Pharmaceutical Scientists Book PDF

Download full Drug Stability For Pharmaceutical Scientists books PDF, EPUB, Tuebl, Textbook, Mobi or read online Drug Stability For Pharmaceutical Scientists anytime and anywhere on any device. Get free access to the library by create an account, fast download and ads free. We cannot guarantee that every book is in the library.

Drug Stability for Pharmaceutical Scientists

Drug Stability for Pharmaceutical Scientists
  • Author : Thorsteinn Loftsson
  • Publisher :Unknown
  • Release Date :2014-01-25
  • Total pages :170
  • ISBN : 0124115624
GET BOOK HERE

Summary : 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

Drug Stability for Pharmaceutical Scientists

Drug Stability for Pharmaceutical Scientists
  • Author : Thorsteinn Loftsson
  • Publisher :Unknown
  • Release Date :2014-02-07
  • Total pages :163
  • ISBN : 9780124115484
GET BOOK HERE

Summary : 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, and the influence of external factors on reaction rates.

Drug Stability

Drug Stability
  • Author : Jens Thurø Carstensen
  • Publisher :Unknown
  • Release Date :1995
  • Total pages :601
  • ISBN : 09876543XX
GET BOOK HERE

Summary : 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

Drug Stability
  • Author : Christopher T. Rhodes,Jens Thurø Carstensen
  • Publisher :Unknown
  • Release Date :2000-01-01
  • Total pages :773
  • ISBN : 9780585393261
GET BOOK HERE

Summary : 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
  • Publisher :Unknown
  • Release Date :2008-11-16
  • Total pages :389
  • ISBN : 0387856277
GET BOOK HERE

Summary : 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
  • Publisher :Unknown
  • Release Date :2009-12-04
  • Total pages :266
  • ISBN : 9781441908896
GET BOOK HERE

Summary : 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.

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing
  • Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :612
  • ISBN : 1439801800
GET BOOK HERE

Summary : 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).

Chemical Stability of Pharmaceuticals

Chemical Stability of Pharmaceuticals
  • Author : Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella,Valentino J Stella
  • Publisher :Unknown
  • Release Date :1986-10-13
  • Total pages :847
  • ISBN : 9780471879558
GET BOOK HERE

Summary : 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, Third Edition, Revised, and Expanded

Drug Stability, Third Edition, Revised, and Expanded
  • Author : Jens T. Carstensen,Christopher Rhodes
  • Publisher :Unknown
  • Release Date :2000-07-28
  • Total pages :792
  • ISBN : 9780824703769
GET BOOK HERE

Summary : 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.

Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS)
  • Author : Fenghe Qiu,Garry Scrivens
  • Publisher :Unknown
  • Release Date :2018-06-28
  • Total pages :512
  • ISBN : 0128027851
GET BOOK HERE

Summary : 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

Pharmaceutical Technology--drug Stability

Pharmaceutical Technology--drug Stability
  • Author : Michael Henry Rubinstein
  • Publisher :Unknown
  • Release Date :1989
  • Total pages :167
  • ISBN : 09876543XX
GET BOOK HERE

Summary :

Stability of Drugs and Dosage Forms

Stability of Drugs and Dosage Forms
  • Author : Sumie Yoshioka,Valentino J. Stella
  • Publisher :Unknown
  • Release Date :2007-05-08
  • Total pages :270
  • ISBN : 0306468298
GET BOOK HERE

Summary : 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.

Protein Formulation and Delivery, Second Edition

Protein Formulation and Delivery, Second Edition
  • Author : Eugene J. McNally,Eugene McNally,Jayne E. Hastedt
  • Publisher :Unknown
  • Release Date :2007-10-26
  • Total pages :376
  • ISBN : 9780849379529
GET BOOK HERE

Summary : This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.

Statistical Design and Analysis of Stability Studies

Statistical Design and Analysis of Stability Studies
  • Author : Shein-Chung Chow
  • Publisher :Unknown
  • Release Date :2007-05-30
  • Total pages :352
  • ISBN : 9781584889069
GET BOOK HERE

Summary : The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

Analytical Techniques in the Pharmaceutical Sciences

Analytical Techniques in the Pharmaceutical Sciences
  • Author : Anette Müllertz,Yvonne Perrie,Thomas Rades
  • Publisher :Unknown
  • Release Date :2016-08-30
  • Total pages :838
  • ISBN : 1493940295
GET BOOK HERE

Summary : 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.

Aulton's Pharmaceutics

Aulton's Pharmaceutics
  • Author : Michael E. Aulton,Kevin Taylor
  • Publisher :Unknown
  • Release Date :2013
  • Total pages :894
  • ISBN : 0702042900
GET BOOK HERE

Summary : Pharmaceutics is one of the most diverse subject areas in all of pharmaceutical science. In brief, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms or medicines. An understanding of pharmaceutics is therefore vital for all pharmacists and those pharmaceutical scientists who are involved with converting a drug or a potential drug into a medicine that can be delivered safely, effectively and conveniently to the patient. Now in its fourth edition, this best-selling textbook in pharmaceutics has been brought completely up to date to reflect the rapid advances in delivery methodologies by eye and injection, advances in drug formulations and delivery methods for special groups (such as children and the elderly), nanomedicine, and pharmacognosy. At the same time the editors have striven to maintain the accessibility of the text for students of pharmacy, preserving the balance between being a suitably pitched introductory text and a clear reflection of the state of the art. provides a logical, comprehensive account of drug design and manufacture includes the science of formulation and drug delivery designed and written for newcomers to the design of dosage forms New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout.

Modern Pharmaceutics

Modern Pharmaceutics
  • Author : Gilbert S. Banker,Juergen Siepmann,Christopher Rhodes
  • Publisher :Unknown
  • Release Date :2002-05-24
  • Total pages :860
  • ISBN : 9780824744694
GET BOOK HERE

Summary : "Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration."

Drug Stability

Drug Stability
  • Author : Jens Thurø Carstensen
  • Publisher :Unknown
  • Release Date :1990
  • Total pages :520
  • ISBN : 09876543XX
GET BOOK HERE

Summary : 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)

An Introduction to Pharmaceutical Sciences

An Introduction to Pharmaceutical Sciences
  • Author : Jiben Roy
  • Publisher :Unknown
  • Release Date :2011-07-25
  • Total pages :446
  • ISBN : 1908818042
GET BOOK HERE

Summary : 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

Essential Pharmacokinetics

Essential Pharmacokinetics
  • Author : Thorsteinn Loftsson
  • Publisher :Unknown
  • Release Date :2015-03-25
  • Total pages :178
  • ISBN : 0128014911
GET BOOK HERE

Summary : Essential Pharmacokinetics: A Primer for Pharmaceutical Scientists is an introduction to the concepts of pharmacokinetics intended for graduate students and new researchers working in the pharmaceutical sciences. This book describes the mathematics used in the mammillary model as well as the application of pharmacokinetics to pharmaceutical product development, and is useful as both a self-study and classroom resource. Content coverage includes detailed discussions of common models and important pharmacokinetic concepts such as biological half-life, clearance, excretion, multiple dosage regimens and more. Numerous equations, practical examples and figures are incorporated to clearly illustrate the theoretical background of pharmacokinetic behavior of drugs and excipients. Shows how to apply basic pharmacokinetic methods to evaluate drugs, excipients and drug products Uses guided practice questions, mathematical concepts and real-world examples for self-assessment and retention purposes Illustrates how to write and evaluate drug registration files

Drug Stability, Third Edition, Revised, and Expanded

Drug Stability, Third Edition, Revised, and Expanded
  • Author : Jens T. Carstensen,Christopher Rhodes
  • Publisher :Unknown
  • Release Date :2000-07-28
  • Total pages :792
  • ISBN : 9780824703769
GET BOOK HERE

Summary : 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.