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

Download or read book Pharmaceutical Technology drug Stability written by Michael Henry Rubinstein and published by . This book was released on 1989 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book Accelerated Predictive Stability APS written by Fenghe Qiu and published by Academic Press. This book was released on 2018-05-14 with total page 514 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

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.

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

Download or read book Pharmaceutical Crystals written by Tong Li and published by John Wiley & Sons. This book was released on 2018-09-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

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.

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)

Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Download or read book Pharmaceutical Biotechnology written by Gary Walsh and published by John Wiley & Sons. This book was released on 2013-04-25 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Download or read book Voigt s Pharmaceutical Technology written by Alfred Fahr and published by John Wiley & Sons. This book was released on 2018-01-17 with total page 885 pages. Available in PDF, EPUB and Kindle. Book excerpt: A textbook which is both comprehensive and comprehensible and that offers easy but scientifically sound reading to both students and professionals Now in its 12th edition in its native German, Voigt's Pharmaceutical Technology is an interdisciplinary textbook covering the fundamental principles of pharmaceutical technology. Available for the first time in English, this edition is produced in full colour throughout, with a concise, clear structure developed after consultation with students, instructors and researchers. This book: Features clear chapter layouts and easily digestible content Presents novel trends, devices and processes Discusses classical and modern manufacturing processes Covers all formulation principles including tablets, ointments, capsules, nanosystems and biopharmaceutics Takes account of legal requirements for both qualitative and quantitative composition Addresses quality assurance considerations Uniquely relates contrasting international pharmacopeia from EU, US and Japan to formulation principles Includes examples and text boxes for quicker data assimilation Written for both students studying pharmacy and industry professionals in the field as well as toxicologists, biochemists, medical lab technicians, Voigt’s Pharmaceutical Technology is the essential resource for understanding the various aspects of pharmaceutical technology.

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Download or read book Essentials of Pharmaceutical Technology written by Ajay Semalty and published by Pharmamed Press. This book was released on 2019-09-03 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delivering the active medicament to the body system for a certain therapeutic action is the central idea of Pharmaceutical technology. A Pharmaceutical drug is delivered through various routes of administration with the help of various kinds of dosage forms. Moreover a drug product should be effective, safe and stable. All the aspects of pharmaceutical texts, dealing with drug delivery basically target these three issues The book covers -Basics of dissolution study, bioavailability and stability studies (and ICH guidelines) in detail with recent guidelines -Most common and popular dosage forms viz. tablet, capsule, parenterals, suspension and emulsion have been discussed Other topics discussed include controlled release products, oral protein delivery etc -USPs of the book are easy language, to the point coverage of topics, pictorial/graphical, tabular presentation and a glossary of official definitions of all important key words of Pharmaceutics. We hope that this book shall be very useful to students as well as teachers as ready source of basics of each and every covered topic.

Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-10 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

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 274 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.