The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.
From Discovery to Approval
Author: Rick Ng
Publisher: John Wiley & Sons
Facts101 is your complete guide to Drugs , From Discovery to Approval. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.
Pharmaceutical sciences, Pharmaceutical sciences
Author: CTI Reviews
Publisher: Cram101 Textbook Reviews
Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval. They focus on using preclinical in vivo and in vitro methods to identify molecules of interest, detailing the targets and criteria for success in each type of testing and defining the value of the information obtained from the various tests. They also define each stage of clinical testing, explain the criteria for success, and outline the requirements for FDA approval. A companion volume by the same editor (Cancer Therapeutics: Experimental and Clinical Agents) reviews existing anticancer drugs and potential anticancer therapies. These two volumes in the Cancer Drug Discovery and Development series reveal how and why molecules become anticancer drugs and thus offer a blueprint for the present and the future of the field.
Preclinical Screening, Clinical Trials, and Approval
Author: Beverly A. Teicher
Publisher: Springer Science & Business Media
A case history approach to drug synthesis and discovery Discover the origins of some of today’s most popular drug therapies. Explore case histories and gain insight into major classes of antibiotics, antiviral drugs, analgesics, steroids, compounds designed to lower cholesterol, and more. Review the steps required for FDA approval. This is a great reference for students in medicinal chemistry, researchers in pharmaceuticals, and medical practitioners.
Author: Daniel Lednicer
Publisher: John Wiley & Sons
It is the purpose and business of the pharmaceutical industry to dis cover, develop, and make available drugs for the care of the sick. The purpose of universities and national laboratories is to provide people and scientific knowledge that can help in the process. This book presents the combined efforts of scientists from the drug in dustry, academic laboratories and national laboratories to describe advances in radiotracer technology in studies on experimental ani mals and living human beings. The authors believe that the technol ogy is now ready for widespread application in the pharmaceutical industry. The goal of this book is to help bring this about. The field of Nuclear Medicine is based on the concept that, if treatment of disease is chemical, the patient's diagnosis should be chemical. Anatomy and histopathology have been the principle ba sis for making a diagnosis. Histopathologic data suffer from being descriptive, subjective, not quantifiable, and based on the study of dead tissue. The era of histopathology as the dominant concept in medical practice is coming to an end. Histopathologic findings are often heterogeneous and a single biopsy will at times not reveal the true nature of the disease, such as the grading of malignancy. Far greater accuracy of staging of disease and in the planning of treat ment is possible through chemistry, as well as by making possible a more suitable selection of a histological biopsy site.
Publisher: Springer Science & Business Media
Category: Juvenile Nonfiction
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.
Drug Discovery and Clinical Applications
Author: Oliver Kayser,Heribert Warzecha
Publisher: John Wiley & Sons
The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries’ trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. New topic - DMPK Optimization Strategy in drug discovery. New chapter on Scaffolds: Small globular proteins as antibody substitutes. Totally updated chapters on Intellectual Property and Marketing 50 new illustrations in full colour Features Accessible, general guide to pharmaceutical research and development. Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. Written by a strong team of scientists with long experience in the pharmaceutical industry. Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: ‘... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. Highly Commended in the medicine category of the BMA 2006 medical book competition Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year
Technology in Transition
Author: Raymond G Hill
Publisher: Elsevier Health Sciences
Für Studierende und Wissenschaftler der Lebenswissenschaften schafft dieses Buch einen schnellen, strukturierten Zugang zur Angewandten Bioinformatik ohne Programmierkenntnisse oder tiefgehende Informatikkenntnisse vorauszusetzen. Es bietet eine Einführung in die tägliche Anwendung der vielfältigen bioinformatischen Werkzeuge und gibt einen ersten Überblick über das sehr komplexe Fachgebiet. Die Kontrolle des vermittelten Stoffs wird durch Übungsbeispiele mit Lösungen gewährleistet. Ein Glossar der zugrundeliegenden Fachtermini sowie ein ausführliches Sachverzeichnis runden das Buch ab. Für die 2. Auflage wurde das Werk umfassend aktualisiert.
Author: Paul M. Selzer,Richard J. Marhöfer,Oliver Koch
Fragment-based drug discovery is a rapidly evolving area of research, which has recently seen new applications in areas such as epigenetics, GPCRs and the identification of novel allosteric binding pockets. The first fragment-derived drug was recently approved for the treatment of melanoma. It is hoped that this approval is just the beginning of the many drugs yet to be discovered using this fascinating technique. This book is written from a Chemist's perspective and comprehensively assesses the impact of fragment-based drug discovery on a wide variety of areas of medicinal chemistry. It will prove to be an invaluable resource for medicinal chemists working in academia and industry, as well as anyone interested in novel drug discovery techniques.
Author: Steven Howard,Chris Abell
Publisher: Royal Society of Chemistry
The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth.
Author: SK Gupta
Publisher: JP Medical Ltd
New strategies and techniques for today's fast-paced discoveryprocess Today, the pressure is on for high-throughput approaches toaccelerate the generation, identification, and optimization ofmolecules with desirable drug properties. As traditional methods ofanalysis become antiquated, new analytical strategies andtechniques are necessary to meet sample throughput requirements andmanpower constraints. Among them, mass spectrometry has grown to bea front-line tool throughout drug discovery. Integrated Strategies for Drug Discovery Using Mass Spectrometryprovides a thorough review of current analytical approaches,industry practices, and strategies in drug discovery. The topicsrepresent current industry benchmarks in specific drug discoveryactivities that deal with proteomics, biomarker discovery,metabonomic approaches for toxicity screening, lead identification,compound libraries, quantitative bioanalytical support,biotransformation, reactive metabolite characterization, leadoptimization, pharmaceutical property profiling, sample preparationstrategies, and automation. THIS BOOK: * Clearly explains how drug discovery and mass spectrometry areinterconnected * Discusses the uses and limitations of various types of massspectrometry in various aspects of drug discovery * Prominently features analytical applications that requiretrace-mixture analysis * Provides industry applications and real-world examples * Shares historical background information on various techniques toaid in the understanding of how and why new methods are now beingemployed to analyze samples
Author: Mike S. Lee
Publisher: John Wiley & Sons
Author: Frank G. Holz,Daniel Pauleikhoff,R.F. Spaide,A.C. Bird
issues in drug discovery and development
Author: Bert Spilker
Publisher: Raven Pr
Category: Business & Economics
Reviews the principles of drug development and clinical pharmacology applicable to all classes of anticancer drugs. Covers every aspect of drug development--from drug discovery to approval and routine use. Details how the successful application of pharmacological principles can improve drug delivery, individualized dosing, and the circumvention of drug resistance; elucideates proven strategies for widening the therapeutic margin between antitumor effects and severe toxicity; and more.
Author: Richard L. Schilsky,Gérard A. Milano,Mark J. Ratain
Publisher: Marcel Dekker
Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry. Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable
How to Make It More Efficient and Cost-Effective
Author: Walter Moos,Susan Miller,Stephen Munk,Barbara Munk
Publisher: Woodhead Publishing
The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an intimate understanding of the mechanisms of pharmacokinetic and pharmacodynamic activity and the processes of drug evaluation is essential. Clinical Trials of Drugs and Biopharmaceuticals provides an overview of current procedures and major issues involved in drug and biopharmaceutical development. The book examines critical biochemical and pharmaceutical considerations for trials conducted during each phase of clinical development. It also reports information related to early pre-clinical evaluations of pharmacological activities and safety before proceeding with initiation of clinical trials. The sections focus on clinical assessments of drugs and biopharmaceuticals such as cardiovascular, respiratory, central nervous system, gastrointestinal and liver, genitourinary, skin, metabolism, and chemotherapeutic drugs as well as vaccines, biotechnology-derived therapeutics, and plant-based medicines. Practical and informative, this step-by-step guide includes information on all four phases of clinical trials prior to licensure and covers the design of post-marketing studies. The editors examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and approved.
Author: Chi-Jen Lee,Lucia H. Lee,Christopher L. Wu,Benjamin R. Lee,Mei-Ling Chen
Publisher: CRC Press
One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.
The Role of Competition Law in Collaborations between Public Research Organizations and Industry
Author: Helen Yu
Publisher: Edward Elgar Publishing
Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc.
How Drugs are Created, Approved, Marketed, and Sold
Author: Bernice Zeldin Schacter
Publisher: Greenwood Publishing Group
Category: Health & Fitness
The health care and pharmacy environments have changed substantially since the first edition of this book. Developments include the new Medicare prescription benefit, a growing emphasis on medication safety, and the dynamic technology driving safety in organized health care settings. Exploring these recent modifications, Pharmacy: What It Is and How It Works, Second Edition encompasses all aspects of pharmacy, from the various roles of pharmacists to particular health care-related events to career-planning information. The book first focuses on the core of pharmacy, providing an overview of the field and a chapter dedicated to pharmacists. After an examination of how drug products are developed, used, and priced, it discusses the important topics of pharmacy technicians, information technology, pharmacy automation, and pharmaceutical care. Subsequent chapters cover the various areas where pharmacists work, including in community, hospital, home health care, and government pharmacies. The book concludes with chapters on the pharmaceutical industry and career planning. Each chapter features learning objectives, summaries, discussion questions, exercises, Web sites of interest, and references. Pharmacies have evolved from the corner drugstores of old. To help navigate the modern field of pharmacy, this text provides a well-written, organized introduction for new pharmacy students, pharmacy technician trainees, and practitioners.
What It Is and How It Works, Second Edition
Author: William N. Kelly
Publisher: CRC Press