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Introduction To Biological And Small Molecule Drug Research And Development

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Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : C. Robin Ganellin,Roy Jefferis,Stanley M. Roberts
Publisher : Academic Press
Release : 2013-05-07
ISBN : 0123977703
Language : En, Es, Fr & De

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Book Description :

Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : Jill M. Carton,William R. Strohl
Publisher : Elsevier Inc. Chapters
Release : 2013-05-07
ISBN : 0128061944
Language : En, Es, Fr & De

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Book Description :

Throughout human history, the morbidity and mortality associated with human disease has driven medical science into an ever-expanding quest for treatment and cure. Over the past century, a therapeutic approach complementing chemical drugs has been developing which uses proteins and peptides in the treatment of disease. Many innovative protein therapeutic platforms are currently being employed and continue to be developed to attain cures in areas of unmet medical need; these include direct copies of natural protein structure and function as well as proteins with completely novel functionality. Today, protein therapeutics represents the fastest growing sector in the pharmaceutical industry and comprises 16% of prescription drug sales in 2011.

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : Stanley M. Roberts
Publisher : Elsevier Inc. Chapters
Release : 2013-05-07
ISBN : 0128062029
Language : En, Es, Fr & De

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Book Description :

Menopause affects the quality of life for women, sometimes severely. The symptoms can be addressed by treatment with steroids, namely, an oestrogen alone or an oestrogen with a progestin. The treatment is called hormone replacement therapy (HRT). However, for years, HRT has been associated with side effects, for instance, an increased risk of breast or endometrial cancer and stroke. The potentially positive effect of reducing some forms of heart disease is still a matter of debate, while the HRT-related decrease in bone fracture/osteoporosis is more certain. The rise, fall and current status of HRT is summarized in this chapter.

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : Wolfgang Jelkmann
Publisher : Elsevier Inc. Chapters
Release : 2013-05-07
ISBN : 0128062002
Language : En, Es, Fr & De

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Book Description :

The renal hormone erythropoietin (Epo) is essential for the viability and proliferation of the erythrocytic progenitors generating reticulocytes in the bone marrow. Human Epo consists of a chain of 165 amino acid residues and four glycans. The synthesis of Epo is strongly stimulated by hypoxia. Epo deficiency is the primary cause of the anaemia in chronic kidney disease (CKD). For anaemia treatment recombinant human Epo (rhEpo/epoetin and epoetin) is very useful. The drug substance is generally manufactured in EPO complementary DNA (cDNA) transfected Chinese hamster ovary cell cultures. rhEpo therapy is beneficial not only for CKD patients but also for anaemic cancer patients receiving chemotherapy. The expiry of the patents for the first original rhEpo formulations has initiated the production of similar biological medicinal products (‘biosimilars’). The term ‘biosimilar’ should only be used for a medicinal product approved on a strict regulatory pathway (i.e. European Medicines Agency, Food and Drug Administration, etc.). Unfortunately, many claimed ‘biosimilars’ have not been through an approval authority. Furthermore, rhEpo analogues with prolonged survival in circulation (‘biobetter’) have been developed and synthetic Epo mimetic peptides have been developed for therapy. The biological role of Epo outside the bone marrow is the focus of current research.

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : James Samanen
Publisher : Elsevier Inc. Chapters
Release : 2013-05-07
ISBN : 0128061952
Language : En, Es, Fr & De

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Book Description :

Biotechnology has given rise to a broad range of biotherapies or biologics, including biomolecular drugs, vaccines, cell or gene therapies. This chapter focuses on biomolecular drugs, namely monoclonal antibodies (Mabs), cytokines, tissue growth factors and therapeutic proteins. Prior to the US approval of recombinant human insulin in 1982, biomolecular drugs were extracted from natural sources. The tools of molecular biology have dramatically increased the discovery and development of new biopharmaceuticals. The most obvious difference between small-molecule drugs (SMDs) and biomolecular drugs is size, like the difference in weight between a bicycle and a business jet. SMDs and biomolecular drugs are compared in this chapter by structure, molecular weight, preparation, physicochemical properties, and route of administration, as well as distribution, metabolism, serum half-life, dosing regimen, species reactivity, antigenicity & hypersensitivity, clearance mechanisms, drug–drug interactions, and pharmacology. This chapter reviews the differences and similarities in the various stages of drug discovery and development, with respect to cost, probability of success and cycle time. The clinical metrics of overall clinical success rate, stage-related success rate, and clinical cycle time are examined for SMDs and biomolecular drugs. The hybrid class of peptide drugs tends to be equated with biologics, due to their amino acid content and because oral activity is rare. But peptides truly bridge the gap between small molecules and biologics, in terms of physical properties, range of therapy areas and means of production. This chapter summarizes the similarities and differences of peptide drugs with SMDs and biomolecular drugs. The manner in which these agents compare as products with respect to manufacturing and pricing are considered. Two case studies are presented—the antagonists where small-molecule, peptide and Mab agents have competed in the market, and Her2 inhibitors where small-molecule and Mab agents may ultimately synergize as a combination product. Biomolecular drugs have levelled the playing field. All the “big Pharma” companies now have the capacity to develop both types of drugs. Conversely the larger biotech companies are developing the capacity for small-molecule synthesis. Now, with many blockbuster biologics nearing patent expiration, biosimilars are on the way. It's no longer a question of “choose which type”—one will need to know how to discover and develop either type of drug.

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : Matthew P. Coghlan,David Fairman
Publisher : Elsevier Inc. Chapters
Release : 2013-05-07
ISBN : 0128061960
Language : En, Es, Fr & De

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Book Description :

The increasing global prevalence of type 2 diabetes represents a significant burden of disease for afflicted patients and for health care systems. In the developed world poorly controlled diabetes is the leading cause of non-traumatic amputation, blindness and end-stage renal disease requiring dialysis and kidney transplant. Additionally, diabetes represents a significant risk factor for the development of cardiovascular disease with its associated morbidity and premature death. Currently available glucose lowering drugs used to treat type 2 diabetes do not impede progression of the disease. Therefore, as the disease progresses these agents rapidly lose efficacy, first as monotherapy and then in combination, resulting in poorly controlled disease. Clearly, there is a significant need for novel glucose lowering drugs for type 2 diabetes that will deliver sustained efficacy over several years by impeding disease progression. Such agents would reduce the risk of developing the microvascular complications of diabetes that ultimately result in amputation, blindness and kidney transplant. Novel glucose lowering drugs should ideally also exhibit a positive impact on the increased cardiovascular risk associated with diabetes. The incretin-based therapies first entered the market in the mid 2000’s and were heralded for their potential to impede progression of type 2 diabetes and to reduce cardiovascular risk. Through mimicking the actions of the gut incretin hormone GLP-1, these drugs had been shown to lower blood glucose in clinical trials by potentiating glucose stimulated insulin secretion from pancreatic β-cells. Moreover, data from preclinical rodent disease models and isolated human pancreatic islets suggested that these novel agents could preserve pancreatic β-cell function and thus impede disease progression. Further preclinical and clinical data supported the notion that these drugs could also aid blood glucose control by suppressing glucagon secretion, slowing gastric emptying and by suppressing appetite. The incretin-based drugs have potential to reduce cardiovascular risk through their ability to reduce body weight, blood pressure and atherogenic blood lipids. This chapter will review the incretin-based therapies and consider what impact these new drugs have made to date in the pharmacotherapy of type 2 diabetes. The incretin-based therapies are of particular relevance to this book as this class of drugs is composed of two sub-classes, injectable peptide drugs and oral small molecule drugs. The similarities and differences between these small molecule and peptide drugs are described.

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development Book
Author : Andy Barker,David Anrews
Publisher : Elsevier Inc. Chapters
Release : 2013-05-07
ISBN : 0128061987
Language : En, Es, Fr & De

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Book Description :

The epidermal growth factor receptor (EGFR) tyrosine kinase is a target for cancer chemotherapy. This chapter describes the discovery of small-molecule inhibitors of the kinase, their characterization and the medicinal chemistry programme that resulted in the identification of gefitinib. The development and studies undertaken to progress the drug in the clinic are presented together with a brief summary of other inhibitors of the EGFR kinase and their properties.

New Drug Development

New Drug Development Book
Author : J. Rick Turner
Publisher : Springer Science & Business Media
Release : 2010-07-16
ISBN : 9781441964182
Language : En, Es, Fr & De

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Book Description :

New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

Handbook of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology Book
Author : Shayne C. Gad
Publisher : Wiley-Interscience
Release : 2007-06-11
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Describes the use of biotechnology to develop pharmaceuticals. This book gives the professional a basic tool to facilitate the development of biotech medicines by bringing together a general overview of biotechnology used in the drug development process, along with a compendium of regulations and validation methods.

The Science and Business of Drug Discovery

The Science and Business of Drug Discovery Book
Author : Edward D. Zanders
Publisher : Springer Science & Business Media
Release : 2011-07-08
ISBN : 9781441999023
Language : En, Es, Fr & De

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Book Description :

The Science and Business of Drug Discovery is written for those who want to learn about the biopharmaceutical industry and its products whatever their level of technical knowledge. Its aim is to demystify the jargon used in drug development, but in a way that avoids over simplification and the resulting loss of key information. Each of the nineteen chapters is illustrated with figures and tables which clarify some of the more technical points being made. Also included is a drug discovery case history which draws the relevant material together into a single chapter. In recognizing that it is difficult to navigate through the many external resources dealing with drug development, the book has been written to guide the reader towards the most appropriate information sources, including those listed in the two appendices. The following topics are covered: Different types of drugs: from small molecules to stem cells Background to chemistry of small and large molecules Historical background to drug discovery, pharmacology and biotechnology The drug discovery pipeline: from target discovery to marketed medicine Commercial aspects of drug discovery Challenges to the biopharmaceutical industry and its responses Material of specific interest to technology transfer executives, recruiters and pharmaceutical translators.

Genetic Engineering Biotechnology News

Genetic Engineering   Biotechnology News Book
Author : Anonim
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Genetic Engineering Biotechnology News book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Drug Discovery and Development

Drug Discovery and Development Book
Author : H. P. Rang,Daniel Vasella
Publisher : Churchill Livingstone
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

'Drug Discovery and Development' describes the huge complexities involved in bringing a drug to market and how new molecular understanding and techniques can make the process more targeted and successful.

Biochemistry and Cell Biology

Biochemistry and Cell Biology Book
Author : Anonim
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Biochemistry and Cell Biology book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Small Molecule Microarray Synthesis Platform

The Small Molecule Microarray Synthesis Platform Book
Author : Matthew D. Bowman
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Small Molecule Microarray Synthesis Platform book written by Matthew D. Bowman, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Wiley Encyclopedia of Chemical Biology Volume 4

Wiley Encyclopedia of Chemical Biology  Volume 4 Book
Author : Tadhg P. Begley
Publisher : Wiley-Blackwell
Release : 2009-02-03
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The first major reference at the interface of chemistry, biology, and medicine Chemical biology is a rapidly developing field that uses the principles, tools, and language of chemistry to answer important questions in the life sciences. It has enabled researchers to gather critical information about the molecular biology of the cell and is the fundamental science of drug discovery, playing a key role in the development of novel agents for the prevention, diagnosis, and treatment of disease. Now students and researchers across the range of disciplines that use chemical biology techniques have a single resource that encapsulates what is known in the field. It is an excellent place to begin any chemical biology investigation. Major topics addressed in the encyclopedia include: Applications of chemical biology Biomolecules within the cell Chemical views of biology Chemistry of biological processes and systems Synthetic molecules as tools for chemical biology Technologies and techniques in chemical biology Some 300 articles range from pure basic research to areas that have immediate applications in fields such as drug discovery, sensor technology, and catalysis. Novices in the field can turn to articles that introduce them to the basics, whereas experienced researchers have access to articles exploring the cutting edge of the science. Each article ends with a list of references to facilitate further investigation. With contributions from leading researchers and pioneers in the field, the Wiley Encyclopedia of Chemical Biology builds on Wiley's unparalleled reputation for helping students and researchers understand the crucial role of chemistry and chemical techniques in the life sciences.

Liquid Chromatography in Pharmaceutical Development

Liquid Chromatography in Pharmaceutical Development Book
Author : Irving W. Wainer
Publisher : Unknown
Release : 1985
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Liquid Chromatography in Pharmaceutical Development book written by Irving W. Wainer, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Chimie Pure Et Appliqu e

Chimie Pure Et Appliqu  e Book
Author : Anonim
Publisher : Unknown
Release : 2012
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Chimie Pure Et Appliqu e book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Small molecule scaffold synthesis one bead one compound library synthesis and method development in drug discovery

Small molecule scaffold synthesis  one bead one compound library synthesis  and method development in drug discovery Book
Author : Seth M. Dixon
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Small molecule scaffold synthesis one bead one compound library synthesis and method development in drug discovery book written by Seth M. Dixon, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Translational Medicine

Translational Medicine Book
Author : Robert A. Meyers
Publisher : John Wiley & Sons
Release : 2018-07-16
ISBN : 3527336591
Language : En, Es, Fr & De

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Book Description :

This reference work gives a compete overview of the different stages of drug development using a translational approach. The book is structured in different parts, following the different stages in drug development. Almost half of the work is dedicated to core of drug discovery using a translational approach, the identification of appropriate targets and screening methods for the identification of compounds interacting with these targets. The rest of book covers the whole downstream pipeline after the identification of lead compounds, such as bioavailability issues, identification of appropriate drug delivery venues, production and scaling issues and preclinical trials. As has been the case with other works in the encyclopedia, the book is made up of long, comprehensive and authoritative chapters, written by outstanding researchers in the field.