A comprehensive introduction to inorganic chemistry and, specifically, the science of metal-based drugs, Essentials of Inorganic Chemistry describes the basics of inorganic chemistry, including organometallic chemistry and radiochemistry, from a pharmaceutical perspective. Written for students of pharmacy and pharmacology, pharmaceutical sciences, medicinal chemistry and other health-care related subjects, this accessible text introduces chemical principles with relevant pharmaceutical examples rather than as stand-alone concepts, allowing students to see the relevance of this subject for their future professions. It includes exercises and case studies.
Heterocyclic chemistry is of prime importance as a sub-discipline of Organic Chemistry, as millions of heterocyclic compounds are known with more being synthesized regularly Introduces students to heterocyclic chemistry and synthesis with practical examples of applied methodology Emphasizes natural product and pharmaceutical applications Provides graduate students and researchers in the pharmaceutical and related sciences with a background in the field Includes problem sets with several chapters
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.
Essentials of Pharmaceutical Preformulation is a study guide which describes the basic principles of pharmaceutical physicochemical characterisation. Successful preformulation requires knowledge of fundamental molecular concepts (solubility, ionisation, partitioning, hygroscopicity and stability) and macroscopic properties (physical form, such as the crystalline and amorphous states, hydrates, solvates and co-crystals and powder properties), familiarity with the techniques used to measure them and appreciation of their effect on product performance, recognising that often there is a position of compromise to be reached between product stability and bioavailability. This text introduces the basic concepts and discusses their wider implication for pharmaceutical development, with reference to many case examples of current drugs and drug products. Special attention is given to the principles and best-practice of the analytical techniques that underpin preformulation (UV spectrophotometry, TLC, DSC, XRPD and HPLC). The material is presented in the typical order that would be followed when developing a medicine and maps onto the indicative pharmacy syllabus of the Royal Pharmaceutical Society of Great Britain Undergraduate-level pharmacy students and R&D / analytical scientists working in the pharmaceutical sector (with or without a pharmaceutical background) will find this text easy to follow with relevant pharmaceutical examples. Essential study guide for pharmacy and pharmaceutical science students Covers the pharmaceutical preformulation components of the Royal Pharmaceutical Society of Great Britain’s indicative syllabus Easy to follow text highlighted with relevant pharmaceutical examples Self-assessment assignments in a variety of formats Written by authors with both academic and industrial experience Companion website with further information to maximise learning
This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
An expert's view on solving the challenges confronting today's pharmaceutical industry Author John LaMattina, a thirty-year veteran of the pharmaceutical industry and former president of Pfizer's Global R&D Division, is internationally recognized as an expert on the pharmaceutical industry. His first book, Drug Truths: Dispelling the Myths About Pharma R&D, was critically acclaimed for clearing up misconceptions about the pharmaceutical industry and providing an honest account of the contributions of pharmaceutical research and development to human health and well-being. As he toured the country discussing Drug Truths, Dr. LaMattina regularly came across people who were filled with anger, accusing the pharmaceutical industry of making up diseases, hiding dangerous side effects, and more. This book was written in response to that experience, critically examining public perceptions and industry realities. Starting with «4 Secrets that Drug Companies Don't Want You to Know,» Devalued and Distrusted provides a fact-based account of how the pharmaceutical industry works and the challenges it faces. It addresses such critical issues as: Why pharmaceutical R&D productivity has declined Where pharmaceutical companies need to invest their resources What can be done to solve core health challenges, including cancer, diabetes, and neurodegenerative diseases How the pharmaceutical industry can regain public trust and resuscitate its image Our understanding of human health and disease grows daily; however, converting science into medicine is increasingly challenging. Reading Devalued and Distrusted, you'll not only gain a greater appreciation of those challenges, but also the role that the pharmaceutical industry currently plays and can play in solving those challenges. Get to know the author: Read an interview with John LaMattina or watch a video on ChemistryViews! Interview: John LaMattina: 30 Years in Pharma Video: Can the Pharmaceutical Industry Restory its Broken Image?
Ideas in Chemistry and Molecular Sciences gives an account of the most recent results of research in life sciences in Europe based on a selection of leading young scientists participating in the 2008 European Young Chemists Award competition. In addition to this, the authors provide the state of the art of their field of research and the perspective or preview of future directions.
The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” – from a review in E-STREAMS «…a key text in the area of pharmacovigilance…extensively referenced and well-written…a valuable resource…» – from a review in The Pharmaceutical Journal
Hot-melt extrusion (HME) – melting a substance and forcing it through an orifice under controlled conditions to form a new material – is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.
Leading experts illustrate how sophisticated computational data mining techniques can impact contemporary drug discovery and development In the era of post-genomic drug development, extracting and applying knowledge from chemical, biological, and clinical data is one of the greatest challenges facing the pharmaceutical industry. Pharmaceutical Data Mining brings together contributions from leading academic and industrial scientists, who address both the implementation of new data mining technologies and application issues in the industry. This accessible, comprehensive collection discusses important theoretical and practical aspects of pharmaceutical data mining, focusing on diverse approaches for drug discovery—including chemogenomics, toxicogenomics, and individual drug response prediction. The five main sections of this volume cover: A general overview of the discipline, from its foundations to contemporary industrial applications Chemoinformatics-based applications Bioinformatics-based applications Data mining methods in clinical development Data mining algorithms, technologies, and software tools, with emphasis on advanced algorithms and software that are currently used in the industry or represent promising approaches In one concentrated reference, Pharmaceutical Data Mining reveals the role and possibilities of these sophisticated techniques in contemporary drug discovery and development. It is ideal for graduate-level courses covering pharmaceutical science, computational chemistry, and bioinformatics. In addition, it provides insight to pharmaceutical scientists, principal investigators, principal scientists, research directors, and all scientists working in the field of drug discovery and development and associated industries.
Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of «what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?» and «when do the various required activities need to be performed?» Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
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.
Book DescriptionInnovation in the Pharmaceutical Industry traces the discovery and development of drugs in Japan and the UK both historically and sociologically. It includes sixteen case studies of major pharmaceutical developments in the twentieth century, encompassing, among others, beta-blockers, beta-stimulants, inhaled steroids and histamine H2-antagonists. The book illustrates that the four stages of drug development - namely compound, application, organizational authorization and market - are interactively shaped by heterogeneous actors and institutions. The book also identifies three different types of pharmaceutical development - paradigmatic innovation, application innovation and modification-based innovation, all with distinguishable features in the drug development process. Finally, several historical, structural and cultural factors influencing the shaping of medicines are revealed by the comparison between British and Japanese drug innovation. Addressing a number of practical implications for the promotion of the pharmaceutical industry, this book will be of enormous interest to students, researchers and academics specializing in science and technology, and the management of technology and innovation. Practitioners, managers, and policy planners within the pharmaceutical industry will also deem this book invaluable.
An accessible and practical approach to the design and analysis of experiments in the health sciences Design and Analysis of Experiments in the Health Sciences provides a balanced presentation of design and analysis issues relating to data in the health sciences and emphasizes new research areas, the crucial topic of clinical trials, and state-of-the- art applications. Advancing the idea that design drives analysis and analysis reveals the design, the book clearly explains how to apply design and analysis principles in animal, human, and laboratory experiments while illustrating topics with applications and examples from randomized clinical trials and the modern topic of microarrays. The authors outline the following five types of designs that form the basis of most experimental structures: Completely randomized designs Randomized block designs Factorial designs Multilevel experiments Repeated measures designs A related website features a wealth of data sets that are used throughout the book, allowing readers to work hands-on with the material. In addition, an extensive bibliography outlines additional resources for further study of the presented topics. Requiring only a basic background in statistics, Design and Analysis of Experiments in the Health Sciences is an excellent book for introductory courses on experimental design and analysis at the graduate level. The book also serves as a valuable resource for researchers in medicine, dentistry, nursing, epidemiology, statistical genetics, and public health.
A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.