Evaluation Of Drug Candidates For Preclinical Development

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Evaluation of Drug Candidates for Preclinical Development

Chao Han,Charles B. Davis,Binghe Wang
Evaluation of Drug Candidates for Preclinical Development Book PDF

Author : Chao Han,Charles B. Davis,Binghe Wang
Publisher : John Wiley & Sons
Page : 306 pages
File Size : 54,8 Mb
Release : 2010-01-19
Category : Medical
ISBN : 9780470044919

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Evaluation of Drug Candidates for Preclinical Development by Chao Han,Charles B. Davis,Binghe Wang Pdf

Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the "right" drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical—pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment—this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.

Early Drug Development

Fabrizio Giordanetto
Early Drug Development Book PDF

Author : Fabrizio Giordanetto
Publisher : John Wiley & Sons
Page : 816 pages
File Size : 42,8 Mb
Release : 2018-06-11
Category : Science
ISBN : 9783527801763

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Early Drug Development by Fabrizio Giordanetto Pdf

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Preclinical Drug Development

Mark Rogge,David R. Taft
Preclinical Drug Development Book PDF

Author : Mark Rogge,David R. Taft
Publisher : CRC Press
Page : 376 pages
File Size : 50,5 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420084733

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Preclinical Drug Development by Mark Rogge,David R. Taft Pdf

Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula

Early Drug Development

Mitchell N. Cayen
Early Drug Development Book PDF

Author : Mitchell N. Cayen
Publisher : John Wiley & Sons
Page : 507 pages
File Size : 45,6 Mb
Release : 2011-02-25
Category : Medical
ISBN : 9781118035207

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Early Drug Development by Mitchell N. Cayen Pdf

The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Drug Discovery and Development, Third Edition

James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Drug Discovery and Development Third Edition Book PDF

Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publisher : CRC Press
Page : 697 pages
File Size : 52,5 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9781351625142

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Drug Discovery and Development, Third Edition by James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell Pdf

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Evaluation of Drug Candidates for Preclinical Development

Chao Han,Charles B. Davis,Binghe Wang
Evaluation of Drug Candidates for Preclinical Development Book PDF

Author : Chao Han,Charles B. Davis,Binghe Wang
Publisher : John Wiley & Sons
Page : 303 pages
File Size : 52,9 Mb
Release : 2010-01-06
Category : Medical
ISBN : 9780470574881

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Evaluation of Drug Candidates for Preclinical Development by Chao Han,Charles B. Davis,Binghe Wang Pdf

Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the "right" drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.

Oligonucleotide-Based Drugs and Therapeutics

Nicolay Ferrari,Rosanne Seguin
Oligonucleotide Based Drugs and Therapeutics Book PDF

Author : Nicolay Ferrari,Rosanne Seguin
Publisher : John Wiley & Sons
Page : 563 pages
File Size : 43,9 Mb
Release : 2018-06-06
Category : Medical
ISBN : 9781119070306

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Oligonucleotide-Based Drugs and Therapeutics by Nicolay Ferrari,Rosanne Seguin Pdf

A comprehensive review of contemporary antisense oligonucleotides drugs and therapeutic principles, methods, applications, and research Oligonucleotide-based drugs, in particular antisense oligonucleotides, are part of a growing number of pharmaceutical and biotech programs progressing to treat a wide range of indications including cancer, cardiovascular, neurodegenerative, neuromuscular, and respiratory diseases, as well as other severe and rare diseases. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide covering all key aspects of this increasingly popular area of pharmacology and biotech and pharma research, from the basic science behind antisense oligonucleotides chemistry, toxicology, manufacturing, to safety assessments, the design of therapeutic protocols, to clinical experience. Antisense oligonucleotides are single strands of DNA or RNA that are complementary to a chosen sequence. While the idea of antisense oligonucleotides to target single genes dates back to the 1970's, most advances have taken place in recent years. The increasing number of antisense oligonucleotide programs in clinical development is a testament to the progress and understanding of pharmacologic, pharmacokinetic, and toxicologic properties as well as improvement in the delivery of oligonucleotides. This valuable book reviews the fundamentals of oligonucleotides, with a focus on antisense oligonucleotide drugs, and reports on the latest research underway worldwide. • Helps readers understand antisense molecules and their targets, biochemistry, and toxicity mechanisms, roles in disease, and applications for safety and therapeutics • Examines the principles, practices, and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides • Provides guidelines for scientists in drug design and discovery to help improve efficiency, assessment, and the success of drug candidates • Includes interdisciplinary perspectives, from academia, industry, regulatory and from the fields of pharmacology, toxicology, biology, and medicinal chemistry Oligonucleotide-Based Drugs and Therapeutics belongs on the reference shelves of chemists, pharmaceutical scientists, chemical biologists, toxicologists and other scientists working in the pharmaceutical and biotechnology industries. It will also be a valuable resource for regulatory specialists and safety assessment professionals and an important reference for academic researchers and post-graduates interested in therapeutics, antisense therapy, and oligonucleotides.

Rare Diseases and Orphan Products

Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Rare Diseases and Orphan Products Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 50,7 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060

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Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Improving and Accelerating Therapeutic Development for Nervous System Disorders Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 107 pages
File Size : 49,6 Mb
Release : 2014-02-06
Category : Medical
ISBN : 9780309292498

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Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Preclinical Safety Evaluation of Biopharmaceuticals

Joy A. Cavagnaro
Preclinical Safety Evaluation of Biopharmaceuticals Book PDF

Author : Joy A. Cavagnaro
Publisher : Wiley-Interscience
Page : 0 pages
File Size : 55,9 Mb
Release : 2008-08-11
Category : Medical
ISBN : 0470108843

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Preclinical Safety Evaluation of Biopharmaceuticals by Joy A. Cavagnaro Pdf

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.

Development and Evaluation of Drugs

Chi-Jen Lee,Cheng-Hsiung Lu,Lucia H. Lee
Development and Evaluation of Drugs Book PDF

Author : Chi-Jen Lee,Cheng-Hsiung Lu,Lucia H. Lee
Publisher : CRC Press
Page : 256 pages
File Size : 49,6 Mb
Release : 2003-05-28
Category : Medical
ISBN : 0849314011

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Development and Evaluation of Drugs by Chi-Jen Lee,Cheng-Hsiung Lu,Lucia H. Lee Pdf

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market. Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Carrie Markgraf,Thomas Hudzik,David Compton
Nonclinical Assessment of Abuse Potential for New Pharmaceuticals Book PDF

Author : Carrie Markgraf,Thomas Hudzik,David Compton
Publisher : Academic Press
Page : 320 pages
File Size : 40,7 Mb
Release : 2015-07-14
Category : Medical
ISBN : 9780124202160

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Nonclinical Assessment of Abuse Potential for New Pharmaceuticals by Carrie Markgraf,Thomas Hudzik,David Compton Pdf

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy

Development and Evaluation of Drugs

Chi-Jen Lee,Cheng-Hsiung Lu,Lucia H. Lee
Development and Evaluation of Drugs Book PDF

Author : Chi-Jen Lee,Cheng-Hsiung Lu,Lucia H. Lee
Publisher : CRC Press
Page : 256 pages
File Size : 55,8 Mb
Release : 2003-05-28
Category : Medical
ISBN : 1135510253

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Development and Evaluation of Drugs by Chi-Jen Lee,Cheng-Hsiung Lu,Lucia H. Lee Pdf

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market. Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer
Drug Discovery and Evaluation Safety and Pharmacokinetic Assays Book PDF

Author : H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer
Publisher : Springer
Page : 0 pages
File Size : 52,5 Mb
Release : 2013-02-27
Category : Medical
ISBN : 3642252397

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer Pdf

-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
Drug Discovery and Evaluation Methods in Clinical Pharmacology Book PDF

Author : H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
Publisher : Springer Science & Business Media
Page : 576 pages
File Size : 40,9 Mb
Release : 2010-12-15
Category : Medical
ISBN : 9783540898900

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology by H.Gerhard Vogel,Jochen Maas,Alexander Gebauer Pdf

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".