February 24, 2021

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Real World Drug Discovery

Real World Drug Discovery
Author : Robert M. Rydzewski
Publisher : Elsevier
Release Date : 2010-07-07
Category : Medical
Total pages :600
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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.

Real-World Evidence in Drug Development and Evaluation

Real-World Evidence in Drug Development and Evaluation
Author : Harry Yang,Binbing Yu
Publisher : CRC Press
Release Date : 2021-01-11
Category : Mathematics
Total pages :208
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Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

Real-World Evidence Generation and Evaluation of Therapeutics

Real-World Evidence Generation and Evaluation of Therapeutics
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2017-08-05
Category : Medical
Total pages :102
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The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.

Natural Products and Drug Discovery

Natural Products and Drug Discovery
Author : Subhash C. Mandal,Vivekananda Mandal,Tetsuya Konishi
Publisher : Elsevier
Release Date : 2018-02-16
Category : Science
Total pages :776
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Natural Products and Drug Discovery: An Integrated Approach provides an applied overview of the field, from traditional medicinal targets, to cutting-edge molecular techniques. Natural products have always been of key importance to drug discovery, but as modern techniques and technologies have allowed researchers to identify, isolate, extract and synthesize their active compounds in new ways, they are once again coming to the forefront of drug discovery. Combining the potential of traditional medicine with the refinement of modern chemical technology, the use of natural products as the basis for drugs can help in the development of more environmentally sound, economical, and effective drug discovery processes. Natural Products & Drug Discovery: An Integrated Approach reflects on the current changes in this field, giving context to the current shift and using supportive case studies to highlight the challenges and successes faced by researchers in integrating traditional medicinal sources with modern chemical technologies. It therefore acts as a useful reference to medicinal chemists, phytochemists, biochemists, pharma R&D professionals, and drug discovery students and researchers. Reviews the changing role of natural products in drug discovery, integrating traditional knowledge with modern molecular technologies Highlights the potential future role of natural products in preventative medicine Supported by real world case studies throughout

Examining the Impact of Real-World Evidence on Medical Product Development

Examining the Impact of Real-World Evidence on Medical Product Development
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2019-04-05
Category : Medical
Total pages :230
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Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Big Data, Pharmacogenomics and Real-World Research in Pharmacology

Big Data, Pharmacogenomics and Real-World Research in Pharmacology
Author : James Cheng-Chung Wei,Taisei Mushiroda,Wei-Chiao Chang
Publisher : Frontiers Media SA
Release Date : 2020-10-12
Category : Medical
Total pages :129
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Examining the Impact of Real-World Evidence on Medical Product Development

Examining the Impact of Real-World Evidence on Medical Product Development
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2019-05-05
Category : Medical
Total pages :230
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Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Artificial Intelligence in Drug Discovery

Artificial Intelligence in Drug Discovery
Author : Nathan Brown
Publisher : Royal Society of Chemistry
Release Date : 2020-11-12
Category : Computers
Total pages :406
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Artificial Intelligence in Drug Discovery aims to introduce the reader to AI and machine learning tools and techniques, and to outline specific challenges including designing new molecular structures, synthesis planning and simulation.

In Silico Drug Discovery and Design

In Silico Drug Discovery and Design
Author : Claudio N. Cavasotto
Publisher : CRC Press
Release Date : 2015-08-06
Category : Medical
Total pages :558
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In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design. Its main aims are to introduce the theoretical framework and algorithms, discuss the range of validity, strengths and limita

Molecular Pharmacology

Molecular Pharmacology
Author : John Dickenson,Fiona Freeman,Chris Lloyd Mills,Christian Thode,Shiva Sivasubramaniam
Publisher : John Wiley & Sons
Release Date : 2012-11-30
Category : Medical
Total pages :424
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This textbook provides a fresh, comprehensive and accessible introduction to the rapidly expanding field of molecular pharmacology. Adopting a drug target-based, rather than the traditional organ/system based, approach this innovative guide reflects the current advances and research trend towards molecular based drug design, derived from a detailed understanding of chemical responses in the body. Drugs are then tailored to fit a treatment profile, rather than the traditional method of ‘trial and error’ drug discovery which focuses on testing chemicals on animals or cell cultures and matching their effects to treatments. Providing an invaluable resource for advanced under-graduate and MSc/PhD students, new researchers to the field and practitioners for continuing professional development, Molecular Pharmacology explores; recent advances and developments in the four major human drug target families (G-protein coupled receptors, ion channels, nuclear receptors and transporters), cloning of drug targets, transgenic animal technology, gene therapy, pharmacogenomics and looks at the role of calcium in the cell. Current - focuses on cutting edge techniques and approaches, including new methods to quantify biological activities in different systems and ways to interpret and understand pharmacological data. Cutting Edge - highlights advances in pharmacogenomics and explores how an individual’s genetic makeup influences their response to therapeutic drugs and the potential for harmful side effects. Applied - includes numerous, real-world examples and a detailed case-study based chapter which looks at current and possible future treatment strategies for cystic fibrosis. This case study considers the relative merits of both drug therapy for specific classes of mutation and gene therapy to correct the underlying defect. Accessible - contains a comprehensive glossary, suggestions for further reading at the end of each chapter and an associated website that provides a complete set of figures from within the book.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author : Ali S. Faqi
Publisher : Academic Press
Release Date : 2012-11-16
Category : Medical
Total pages :885
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A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

High-Throughput Lead Optimization in Drug Discovery

High-Throughput Lead Optimization in Drug Discovery
Author : Tushar Kshirsagar
Publisher : CRC Press
Release Date : 2008-03-04
Category : Medical
Total pages :256
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A Single Source on Parallel Synthesis for Lead Optimization The end of the previous millennium saw an explosion in the application of parallel synthesis techniques for making compounds for high-throughput screening. Over time, it became clear that more thought in the design phase of library development is necessary to generate high qualit

Drug Discovery

Drug Discovery
Author : Tamas Bartfai,Graham V. Lees
Publisher : Academic Press
Release Date : 2010-07-26
Category : Medical
Total pages :328
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Everyone expects something from the drug industry. Physicians and patients, investors, regulators and administrators all have an active interest. Everyone wants to know what makes drugs ‘work’ medically and economically. Why are drugs so expensive? Is it the drug companies or investors who demand high profits? What governs the pharmacoeconomics? Why are so few diseases treatable? This book opens the windows and doors of the industry telling the story of drug development by using real stories from inside the process. * Co-written by Graham Lees and Tamas Bartfai who has been involved in the development of drugs taken by more that 20 million people every day * Opens the windows and doors of the most regulated industry in the world, the pharmaceutical industry * Tells the story of drug development by using real examples based on current research and events * Provides an objective, lucid account of the successes and failures, shortcomings and constraints of the pharmaceutical and biotech industries * Gives insights into the development of new drugs to combat multiple conditions including cancer and pain * Balanced, unbiased account of how better to translate basic science into drug discovery

Innovative Methods for Rare Disease Drug Development

Innovative Methods for Rare Disease Drug Development
Author : Shein-Chung Chow
Publisher : CRC Press
Release Date : 2020-11-12
Category : Mathematics
Total pages :306
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In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used to treat common conditions. Innovative Methods for Rare Disease Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives. Key Features: Reviews critical issues (e.g., endpoint/margin selection, sample size requirements, and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval accurately and reliably. Makes recommendations to evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols like platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development like gene therapy.

Medicinal Chemistry

Medicinal Chemistry
Author : Norma K Dunlap,Donna M Huryn
Publisher : Garland Science
Release Date : 2018-04-17
Category : Medical
Total pages :375
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Medicinal Chemistry begins with the history of the field, starting from the serendipitous use of plant preparations to current practice of design- and target-based screening methods. Written from the perspective of practicing medicinal chemists, the text covers key drug discovery activities such as pharmacokinetics and patenting, as well as the classes and structures of drug targets (receptors, enzymes, nucleic acids, and protein-protein and lipid interactions) with numerous examples of drugs acting at each type. Selected therapeutic areas include drugs to treat cancer, infectious diseases, and central nervous system disorders. Throughout the book, historical and current examples illustrate the progress to market and case studies explore the applications of concepts discussed in the text. Each chapter features a Journal Club, as well as review and application questions to enhance and test comprehension. This textbook is ideal for upper-level undergraduates and graduate students taking a one-semester survey course on medicinal chemistry and/or drug discovery, as well as scientists entering the pharmaceutical industry.