Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Download or read book Introduction to Market Access for Pharmaceuticals written by Mondher Toumi and published by CRC Press. This book was released on 2017-01-12 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

Download or read book HPLC Method Development for Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2011-09-21 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. - Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory - Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) - Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2018-08-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.

Download or read book The Life Cycle of Pharmaceuticals in the Environment written by B.M. Peake and published by Elsevier. This book was released on 2015-11-13 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship. - Encompasses the full lifecycle of common pharmaceuticals, from prescription and dispensing practices to their occurrence in a range of different types of natural waters and their environmental impact - Explores the role of the healthcare system and its affect on users - Beneficial for environmental engineers involved in the design and operation of appropriate degradation technologies of the pharmaceutical prescription and disposal practices

Download or read book The Colonial Life of Pharmaceuticals written by Laurence Monnais and published by Cambridge University Press. This book was released on 2019-08-22 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative examination of the early globalization of the pharmaceutical industry, arguing that colonialism was crucial to the worldwide diffusion of modern medicines.

Download or read book Pharmaceuticals in the Environment written by Klaus Kümmerer and published by Springer Science & Business Media. This book was released on 2008-10-10 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the success of the first edition, this pioneering study of pharmaceuticals in the environment has been updated and greatly extended. It includes the status of research on pharmaceuticals in soil, with attention to terrestrial and aquatic environments as well as new substance categories such as tetracylines and chinolones and the latest results concerning contamination of the environment and risk reduction.

Download or read book Raman and SERS Investigations of Pharmaceuticals written by Monica Baia and published by Springer Science & Business Media. This book was released on 2008-06-11 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last several years it has become apparent to most researchers that interdisciplinary research is the key to success in the sciences’ future. The present book exemplifies such interdisciplinary work. Thus, some new derivatives have been prepared by chemists and consecutively analyzed by physicists in order to better understand their physical-chemical properties for future tests to be performed by pharmacists. The book consists of an introductory section and other eight chapters. First, the fundamentals of infrared, Raman and surface-enhanced Raman spectroscopy and those of the theoretical methods employed for the vibrational prediction modes are highlighted. The SERS investigations illustrated in the following chapters are focused on different kinds of drugs: tranquilizers and sedatives, anti-inflammatory drugs, vitamins, drugs with anti-bacterial properties, etc. Since there is an increased interest in designing highly effective and controllable SERS-active substrates, a few newly developed substrates that could contribute to a deeper understanding and knowledge of the adsorption behavior of various types of molecules of pharmaceutical and medical interest are also presented.

Download or read book Solid State Characterization of Pharmaceuticals written by Richard A. Storey and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials. Selection of the optimum solid form is a critical aspect of the development of pharmaceutical compounds, due to their ability to exist in more than one form or crystal structure (polymorphism). These polymorphs exhibit different physical properties which can affect their biopharmaceutical properties. This book provides an up-to-date review of the current techniques used to characterize pharmaceutical solids. Ensuring balanced, practical coverage with industrial relevance, it covers a range of key applications in the field. The following topics are included: Physical properties and processes Thermodynamics Intellectual guidance X-ray diffraction Spectroscopy Microscopy Particle sizing Mechanical properties Vapour sorption Thermal analysis & Calorimetry Polymorph prediction Form selection

Download or read book Equitable Access to High Cost Pharmaceuticals written by Zaheer-Ud-Din Babar and published by Academic Press. This book was released on 2018-02-27 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. - Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs - Incorporates existing guidelines and recommendations by international organizations - Compares and contrasts how different countries fund and police high-cost drug access - Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing - Reviews novel pharmaceuticals of current research interest

Download or read book Significant Pharmaceuticals Reported in US Patents written by Thomas F. DeRosa and published by Elsevier. This book was released on 2010-07-07 with total page 701 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant Pharmaceuticals Reported in US Patents identifies the next generation of pharmaceuticals reported in US Patents. This "hands-on" title provides explicit laboratory methods for preparing the most recent and effective medications. Each entry documents the biological testing protocols used to evaluate a drug and the significance of the current treatment agent over previous methods. Pharmaceuticals are included in this review only if at least two of the following criteria were met: Effectiveness in treating an illness, Innovative, ease of preparation, synergy with existing Medications. Pharmaceuticals are reported for 27 separate classes of illness, including: AIDS, Alzheimer's Disease, Cardiovascular Disorders, Diabetes, Epilepsy, Hepatitis C, Osteoporosis, Obesity and Sleep Disorders. Significant Pharmaceuticals Reported in US Patents has been designed to be used as both a reference and synthetic guide for pharmaceutical, medicinal and organic chemists and graduate students. Researchers working in other areas will also find the information valuable as in many instances intermediates or the next generation pharmaceutical are readily convertible into other industrial products including: anti-oxidants, chemical additives, herbicides, polymer precursors, water purification agents. Clear structural depictions of reagents and chemical transformations have been supplied to permit the identification of other future applications. Identifies next generation pharmaceuticals Provides practical preparation methods for each active agent and derivatives Documents the analytical characterization and biological testing results of active agents

Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia

Download or read book Global Pharmaceuticals written by Adriana Petryna and published by Duke University Press. This book was released on 2006-03-15 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div

Download or read book Bioanalysis of Pharmaceuticals written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods. Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.

Download or read book Marijuana As Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 2000-12-30 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Some people suffer from chronic, debilitating disorders for which no conventional treatment brings relief. Can marijuana ease their symptoms? Would it be breaking the law to turn to marijuana as a medication? There are few sources of objective, scientifically sound advice for people in this situation. Most books about marijuana and medicine attempt to promote the views of advocates or opponents. To fill the gap between these extremes, authors Alison Mack and Janet Joy have extracted critical findings from a recent Institute of Medicine study on this important issue, interpreting them for a general audience. Marijuana As Medicine? provides patientsâ€"as well as the people who care for themâ€"with a foundation for making decisions about their own health care. This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. The dangers of smoking marijuana, as well as the effects of its active chemical components on the immune system and on psychological health. The potential use of marijuana-based medications on symptoms of AIDS, cancer, multiple sclerosis, and several other specific disorders, in comparison with existing treatments. Marijuana As Medicine? introduces readers to the active compounds in marijuana. These include the principal ingredient in Marinol, a legal medication. The authors also discuss the prospects for developing other drugs derived from marijuana's active ingredients. In addition to providing an up-to-date review of the science behind the medical marijuana debate, Mack and Joy also answer common questions about the legal status of marijuana, explaining the conflict between state and federal law regarding its medical use. Intended primarily as an aid to patients and caregivers, this book objectively presents critical information so that it can be used to make responsible health care decisions. Marijuana As Medicine? will also be a valuable resource for policymakers, health care providers, patient counselors, medical faculty and studentsâ€"in short, anyone who wants to learn more about this important issue.

Download or read book Dictionary of Pharmaceutical Medicine written by Gerhard Nahler and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.