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Author :
Publisher :
ISBN 13 :
Total Pages : 356 pages
Book Rating : 4.3/5 (91 download)
Download or read book PAREXEL's Bio/pharmaceutical R & D Statistical Sourcebook written by and published by . This book was released on 2006 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 406 pages
Book Rating : 4.5/5 (86 download)
Download or read book PAREXEL's Pharmaceutical R&D Statistical Sourcebook written by and published by . This book was released on 2001 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Bruce Rasmussen
Publisher : Edward Elgar Publishing
ISBN 13 : 1849805512
Total Pages : 335 pages
Book Rating : 4.8/5 (498 download)
Download or read book Innovation and Commercialisation in the Biopharmaceutical Industry written by Bruce Rasmussen and published by Edward Elgar Publishing. This book was released on 2010-01-01 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: The processes of discovery, testing and distribution of new medicines have undergone radical change in recent decades, from a focus on small molecule drugs to biomedicine and related technologies. Bruce Rasmussen very effectively draws upon modern theories of the firm, data analysis, and case studies to provide important insights into the consequences of this change. He offers convincing evidence that contradicts the widely-held view that the biopharmaceutical sector has not generated considerable economic value. Frank R. Lichtenberg, Columbia University, US Bio- and pharmaceutical industry discovery is a distressed asset today. Why? Bruce Rasmussen s book is a timely and very informative work, building on rich data sources and extensive economic research, on a subject of concern to us all. Is medicine discovery in permanent decline? Are the biotechnology and traditional pharma groups on a collision course, will the traditional group absorb the new, will integration take place, will a new discovery model emerge? I commend Bruce s book to all who wish to understand what is happening. David W. Anstice, Merck & Co., Inc. This path-breaking book addresses the ongoing implications for traditional pharmaceutical companies and biopharmaceutical start-ups of the realignment of the industry knowledge-base. The theoretical approach draws on the modern theory of the firm and related ideas in order to better define the concept of the business model, which is employed to guide the case studies and empirical analysis in the book. The author shows that while traditional pharmaceutical companies have successfully adjusted their business models to meet the challenges of biotechnology, biopharmaceutical start-ups have experienced more problems. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. However, this has been captured disproportionately by a handful of large, fully-integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical companies. This highly focused book will be a captivating read for innovation and biopharmaceutical industry analysts, as well as advisers formulating policies to support the development of the biopharmaceutical sector. Academics working on innovation and biotechnology, as well as scientists engaged in research in the life sciences, will also find this book of particular interest.
Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Publisher :
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.3/5 (91 download)
Download or read book Biologics and Biosimilars written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy and published by . This book was released on 2010 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : John Talbot
Publisher : John Wiley & Sons
ISBN 13 : 1119952107
Total Pages : 751 pages
Book Rating : 4.1/5 (199 download)
Download or read book Stephens' Detection and Evaluation of Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2011-10-28 with total page 751 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author : Michael Tansey
Publisher : Oxford University Press, USA
ISBN 13 : 0199974586
Total Pages : 241 pages
Book Rating : 4.1/5 (999 download)
Download or read book Intelligent Drug Development written by Michael Tansey and published by Oxford University Press, USA. This book was released on 2014 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.
Author : Ana Aizcorbe
Publisher : University of Chicago Press
ISBN 13 : 022653099X
Total Pages : 535 pages
Book Rating : 4.2/5 (265 download)
Download or read book Measuring and Modeling Health Care Costs written by Ana Aizcorbe and published by University of Chicago Press. This book was released on 2018-03-05 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health care costs represent a nearly 18% of U.S. gross domestic product and 20% of government spending. While there is detailed information on where these health care dollars are spent, there is much less evidence on how this spending affects health. The research in Measuring and Modeling Health Care Costs seeks to connect our knowledge of expenditures with what we are able to measure of results, probing questions of methodology, changes in the pharmaceutical industry, and the shifting landscape of physician practice. The research in this volume investigates, for example, obesity’s effect on health care spending, the effect of generic pharmaceutical releases on the market, and the disparity between disease-based and population-based spending measures. This vast and varied volume applies a range of economic tools to the analysis of health care and health outcomes. Practical and descriptive, this new volume in the Studies in Income and Wealth series is full of insights relevant to health policy students and specialists alike.
Author : Adnan Nasir
Publisher : Springer
ISBN 13 : 3319090275
Total Pages : 355 pages
Book Rating : 4.3/5 (19 download)
Download or read book Clinical Dermatology Trials 101 written by Adnan Nasir and published by Springer. This book was released on 2014-11-12 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Dermatology Trials 101 provides dermatologists with a handbook that allows them to become familiar with all aspects of clinical trials. Everything from obtaining the necessary tools and equipment, complying with local, federal, and international guidelines and regulations, and hiring and training staff for the safe and up-to-date conduct of dermatology clinical trials is covered. Written by leading experts in the field, Clinical Dermatology Trials 101 is the only clinical trial how-to available for dermatologists. With skin disease affecting nearly seventy percent of the population over a lifetime, and the rate of development of new drugs and devices for dermatologic use increasing at an exponential rate, there is a tremendous need for training and developing dermatology clinical research facilities to expedite the translation of basic and applied research, from bench to bedside. This is useful for practicing dermatologists, academic dermatologists, dermatology residents, clinical research fellows, dermatology fellows, research scientists, industry dermatologists, and medical students.
Author : Jean-Paul Renaud
Publisher : John Wiley & Sons
ISBN 13 : 1118900405
Total Pages : 692 pages
Book Rating : 4.1/5 (189 download)
Download or read book Structural Biology in Drug Discovery written by Jean-Paul Renaud and published by John Wiley & Sons. This book was released on 2020-01-27 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the most comprehensive and up-to-date overview of structure-based drug discovery covering both experimental and computational approaches, Structural Biology in Drug Discovery: Methods, Techniques, and Practices describes principles, methods, applications, and emerging paradigms of structural biology as a tool for more efficient drug development. Coverage includes successful examples, academic and industry insights, novel concepts, and advances in a rapidly evolving field. The combined chapters, by authors writing from the frontlines of structural biology and drug discovery, give readers a valuable reference and resource that: Presents the benefits, limitations, and potentiality of major techniques in the field such as X-ray crystallography, NMR, neutron crystallography, cryo-EM, mass spectrometry and other biophysical techniques, and computational structural biology Includes detailed chapters on druggability, allostery, complementary use of thermodynamic and kinetic information, and powerful approaches such as structural chemogenomics and fragment-based drug design Emphasizes the need for the in-depth biophysical characterization of protein targets as well as of therapeutic proteins, and for a thorough quality assessment of experimental structures Illustrates advances in the field of established therapeutic targets like kinases, serine proteinases, GPCRs, and epigenetic proteins, and of more challenging ones like protein-protein interactions and intrinsically disordered proteins
Author : Robert M. Rydzewski
Publisher : Elsevier
ISBN 13 : 0080914888
Total Pages : 535 pages
Book Rating : 4.0/5 (89 download)
Download or read book Real World Drug Discovery written by Robert M. Rydzewski and published by Elsevier. This book was released on 2010-07-07 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research presents this kind of map of the landscape of drug discovery. In a single, readable volume it outlines processes and explains essential concepts and terms for the recent science graduate wondering what to expect in pharma or biotech, the medicinal chemist seeking a broader and more timely understanding of the industry, or the contractor or collaborator whose understanding of the commercial drug discovery process could increase the value of his contribution to it. - Interviews with well-known experts in many of the fields involved, giving insightful comments from authorities on many of the sub-disciplines important to cutting edge drug discovery. - Helpful suggestions gleaned from years of experience in biotech and pharma, which represents a repository drug discovery "lore" not previously available in any book. - "Periodic Table of Drugs" listing current top-selling drugs arranged by target and laid out so that structural similarities and differences are plain and clear. - Extensive use of diagrams to illustrate concepts like biotech startup models, preteomic profiling for target identification, Gantt charts for project planning, etc.
Author : Walter A. Garcia-Fontes
Publisher : Springer Science & Business Media
ISBN 13 : 8493806277
Total Pages : 105 pages
Book Rating : 4.4/5 (938 download)
Download or read book Incentives for Research, Development, and Innovation in Pharmaceuticals written by Walter A. Garcia-Fontes and published by Springer Science & Business Media. This book was released on 2012-01-12 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incentives for innovation are particularly relevant in the pharmaceutical industry where not all social needs provide equally profitable opportunities and where most OECD countries try to implement different measures that promote research in these less profitable areas. This book describes how incentives can be provided to deal with less profitable activities when no clear markets exist for the innovations. The book discusses alternative mechanisms to substitute for inexistent markets, situations where traditional instruments have proven totally insufficient, and the clear mismatch between the size of the markets being targeted and the incentives being provided. Patents become an ineffective way to incentivise R&D when the appropriability is low; this book provides alternative ideas such as allowing for a period of data exclusivity to firms that develop new drugs.
Author : Alain A. Vertes
Publisher : John Wiley & Sons
ISBN 13 : 1118846206
Total Pages : 776 pages
Book Rating : 4.1/5 (188 download)
Download or read book Stem Cells in Regenerative Medicine written by Alain A. Vertes and published by John Wiley & Sons. This book was released on 2015-09-14 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields.
Author : David C Pryde
Publisher : Royal Society of Chemistry
ISBN 13 : 1849738068
Total Pages : 488 pages
Book Rating : 4.8/5 (497 download)
Download or read book Orphan Drugs and Rare Diseases written by David C Pryde and published by Royal Society of Chemistry. This book was released on 2014 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an up-to-date monograph on the drug discovery and regulatory elements of therapuetics used to treat rare or "orphan" diseases.
Author :
Publisher : John Wiley & Sons
ISBN 13 : 111953030X
Total Pages : 6057 pages
Book Rating : 4.1/5 (195 download)
Download or read book Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set written by and published by John Wiley & Sons. This book was released on 2021-04-20 with total page 6057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Burger’s Medicinal Chemistry, Drug Discovery and Development Explore the freshly updated flagship reference for medicinal chemists and pharmaceutical professionals The newly revised eighth edition of the eight-volume Burger’s Medicinal Chemistry, Drug Discovery and Development is the latest installment in this celebrated series covering the entirety of the drug development and discovery process. With the addition of expert editors in each subject area, this eight-volume set adds 35 chapters to the extensive existing chapters. New additions include analyses of opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, and industrial-academic collaboration structures. Along with the incorporation of practical material on drug hunting, the set features sections on drug discovery, drug development, cardiovascular diseases, metabolic diseases, immunology, cancer, anti-Infectives, and CNS disorders. The text continues the legacy of previous volumes in the series by providing recognized, renowned, authoritative, and comprehensive information in the area of drug discovery and development while adding cutting-edge new material on issues like the use of artificial intelligence in medicinal chemistry. Included: Volume 1: Methods in Drug Discovery, edited by Kent D. Stewart Volume 2: Discovering Lead Molecules, edited by Kent D. Stewart Volume 3: Drug Development, edited by Ramnarayan S. Randad and Michael Myers Volume 4: Cardiovascular, Endocrine, and Metabolic Diseases, edited by Scott D. Edmondson Volume 5: Pulmonary, Bone, Immunology, Vitamins, and Autocoid Therapeutic Agents, edited by Bryan H. Norman Volume 6: Cancer, edited by Barry Gold and Donna M. Huryn Volume 7: Anti-Infectives, edited by Roland E. Dolle Volume 8: CNS Disorders, edited by Richard A. Glennon Perfect for research departments in the pharmaceutical and biotechnology industries, Burger’s Medicinal Chemistry, Drug Discovery and Development can be used by graduate students seeking a one-stop reference for drug development and discovery and deserves its place in the libraries of biomedical research institutes, medical, pharmaceutical, and veterinary schools.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher :
ISBN 13 :
Total Pages : 192 pages
Book Rating : 4.0/5 ( download)
Download or read book Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Feroz Jameel
Publisher : John Wiley & Sons
ISBN 13 : 0470118121
Total Pages : 978 pages
Book Rating : 4.4/5 (71 download)
Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-08-09 with total page 978 pages. Available in PDF, EPUB and Kindle. Book excerpt: A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 149874348X
Total Pages : 599 pages
Book Rating : 4.4/5 (987 download)
Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 599 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.
