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A Comprehensive Guide To Toxicology In Preclinical Drug Development

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A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2012-11-16
ISBN : 0123878152
Language : En, Es, Fr & De

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Book Description :

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

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2016-11-03
ISBN : 0128036214
Language : En, Es, Fr & De

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Book Description :

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Preclinical Development Handbook

Preclinical Development Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 9780470249048
Language : En, Es, Fr & De

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Book Description :

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Flavonoid Pharmacokinetics

Flavonoid Pharmacokinetics Book
Author : Neal M. Davies,Jaime A. Yáñez
Publisher : John Wiley & Sons
Release : 2012-11-05
ISBN : 1118354400
Language : En, Es, Fr & De

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Book Description :

SETS FORTH A FRAMEWORK FOR THE ANALYSIS AND STUDY OF FLAVONOIDS More and more dietary supplements contain flavonoids. These products are typically viewed as food rather than drug products by regulatory agencies and therefore not subjected to rigorous clinical trials before they are marketed to the general public. As a result, the use of flavonoid-containing supplements presents a potential public health risk. From discovery to therapeutic application, this book is a comprehensive guide to both achiral and chiral flavonoids, enabling researchers to perform essential preclinical and clinical pharmacokinetics studies in order to ensure the efficacy of flavonoids marketed for therapeutic use. Moreover, the book examines the safety and toxicology of flavonoids as well as flavonoid-drug interactions. With contributions from a multidisciplinary team of leading researchers, Flavonoids Pharmacokinetics reviews and synthesizes the most recent research findings and results from preclinical and clinical studies. The book begins with a comprehensive overview of polyphenols and flavonoids. Next, the book covers: Methods of analysis of achiral flavonoids Preclinical pharmacokinetic of flavonoids Toxicology and safety of flavonoids Methods of analysis for chiral flavonoids Clinical pharmacokinetics of flavonoids Flavonoids and drug interactions Throughout the book, the authors provide examples that demonstrate the use of pharmacokinetics concepts during the preclinical and clinical drug development process. Flavonoid Pharmacokinetics is written for pharmaceutical, food, and nutritional scientists and students, offering the tools they need to thoroughly analyze and test flavonoids and flavonoid-containing supplements to ensure their safety and efficacy.

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals Book
Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Release : 2013-03-07
ISBN : 1118679385
Language : En, Es, Fr & De

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Book Description :

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: Includes an overview of biopharmaceuticals with information onregulation and methods of production Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics Book
Author : Michelle A. Rudek,Cindy H. Chau,William D. Figg,Howard L. McLeod
Publisher : Springer Science & Business Media
Release : 2014-01-10
ISBN : 1461491355
Language : En, Es, Fr & De

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Book Description :

There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development

ADME Enabling Technologies in Drug Design and Development

ADME Enabling Technologies in Drug Design and Development Book
Author : Donglu Zhang,Sekhar Surapaneni
Publisher : John Wiley & Sons
Release : 2012-04-13
ISBN : 1118180763
Language : En, Es, Fr & De

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Book Description :

A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the developmentof analytical techniques such as mass spectrometry and molecularbiology tools, resulting in important advances in drug discovery,particularly in the area of absorption, distribution, metabolism,and excretion (ADME). ADME-Enabling Technologies in Drug Design and Developmentfocuses on the current state of the art in the field, presenting acomprehensive review of the latest tools for generating ADME datain drug discovery. It examines the broadest possible range ofavailable technologies, giving readers the information they need tochoose the right tool for a given application, a key requisite forobtaining favorable results in a timely fashion for regulatoryfilings. With over thirty contributed chapters by an internationalteam of experts, the book provides: A thorough examination of current tools, covering bothelectronic/mechanical technologies and biologically based ones Coverage of applications for each technology, including keyparameters, optimal conditions for intended results, protocols, andcase studies Detailed discussion of emerging tools and techniques, from stemcells and genetically modified animal models to imagingtechnologies Numerous figures and diagrams throughout the text Scientists and researchers in drug metabolism, pharmacology,medicinal chemistry, pharmaceutics, toxicology, and bioanalyticalscience will find ADME-Enabling Technologies in Drug Design andDevelopment an invaluable guide to the entire drug developmentprocess, from discovery to regulatory issues.

Development and Approval of Combination Products

Development and Approval of Combination Products Book
Author : Evan B. Siegel
Publisher : John Wiley & Sons
Release : 2008-06-09
ISBN : 0470371196
Language : En, Es, Fr & De

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Book Description :

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

Cancer Research

Cancer Research Book
Author : Anonim
Publisher : Unknown
Release : 2000-11
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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

Oligonucleotide Based Drugs and Therapeutics

Oligonucleotide Based Drugs and Therapeutics Book
Author : Nicolay Ferrari,Rosanne Seguin
Publisher : John Wiley & Sons
Release : 2018-07-31
ISBN : 1118537335
Language : En, Es, Fr & De

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Book Description :

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.

Pharmacology of Ocular Therapeutics

Pharmacology of Ocular Therapeutics Book
Author : Thirumurthy Velpandian
Publisher : Springer
Release : 2016-02-29
ISBN : 3319254987
Language : En, Es, Fr & De

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Book Description :

This book comprises an integrated review of ocular therapeutics across all relevant fields. It addresses the real-world requirements of ophthalmologists, pharmacists and optometrists, as observed through working alongside these practitioners for two decades. Knowledge surrounding agents used in ophthalmic practice has, historically, been scattered. The book facilitates understanding of ocular drug therapy by compiling all key aspects of the pharmacology, toxicology, pharmaceutical science, ocular biochemistry and cell biology of these agents. Chapters detail drug transfer across barriers, systemic toxicity of topically applied drugs, autonomic drugs used for diagnostics, as well as anti-inflammatory, antiallergic, glaucoma and antimicrobial therapies, and avenues for the development of new ocular drugs. Applications of extemporaneously prepared formulations are described to inform day-to-day clinical practice. The use of mucoadhesive polymers in tear substitutes, ocular drug delivery systems, stem cell therapy, pharmacogenomics and antiangiogenic ocular chemotherapy are also explored. The book also provides insights from drugs of herbal origin, and a historical perspective on drugs for ocular use. Practicing and resident ophthalmologists, optometrists, pharmacists, nursing professionals, scholars in ocular drug research and students will equally benefit from this comprehensive guide.

Plunkett s Biotech Genetics Industry Almanac

Plunkett s Biotech   Genetics Industry Almanac Book
Author : Anonim
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The only complete guide to the technologies and companies in the biotech and genetics industry.

GEN Guide to Biotechnology Companies

GEN Guide to Biotechnology Companies Book
Author : Anonim
Publisher : Unknown
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download GEN Guide to Biotechnology Companies book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Medical Scientific Authors Guide

The Medical   Scientific Authors  Guide Book
Author : Anonim
Publisher : Le Jacq Pub
Release : 1984
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Alphabetical listing of manuscript instructions to over 500 medical and scientific journals. Also contains a list of journal titles by subject.

Pharmaceutical Salts

Pharmaceutical Salts Book
Author : P. Heinrich Stahl,Camille G. Wermuth
Publisher : John Wiley & Sons
Release : 2002-08-23
ISBN : 9783906390260
Language : En, Es, Fr & De

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Book Description :

A team of 17 authors from academia and pharmaceutical industry, in their contributions to this book, present the necessary theoretical foundations as well as detailed practical experience in the choice of pharmaceutically active salts.

Guide to the Literature of Pharmacy and the Pharmaceutical Sciences

Guide to the Literature of Pharmacy and the Pharmaceutical Sciences Book
Author : Theodora Andrews
Publisher : Libraries Unltd Incorporated
Release : 1986
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Compilation of 958 sources intended primarily for librarians. Attempts to cover all pharmaceutical areas. Emphasis on reference materials. Arranged in three parts, i.e., reference, sources, source materials by subject areas, and other sources (periodicals and data bases). Author/title and subject indexes.

Comprehensive medicinal chemistry II

Comprehensive medicinal chemistry II Book
Author : John B. Taylor,D. J. Triggle
Publisher : Elsevier Science Ltd
Release : 2007
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The first edition of Comprehensive Medicinal Chemistry was published in 1990 and very well received. Comprehensive Medicinal Chemistry II is much more than a simple updating of the contents of the first edition. Completely revised and expanded, this new edition has been refocused to reflect the significant developments and changes over the past decade in genomics, proteomics, bioinformatics, combinatorial chemistry, high-throughput screening and pharmacology, and more. The content comprises the most up-to-date, authoritative and comprehensive reference text on contemporary medicinal chemistry and drug research, covering major therapeutic classes and targets, research strategy and organisation, high-throughput technologies, computer-assisted design, ADME and selected case histories. It is this coverage of the strategy, technologies, principles and applications of medicinal chemistry in a single work that will make Comprehensive Medicinal Chemistry II a unique work of reference and a single point of entry to the literature for pharmaceutical and biotechnology scientists of all disciplines and for many industry executives as well.Comprehensive Medicinal Chemistry II will be available online in 2007 via the proven platform ScienceDirect providing the user with enhanced features such as cross-referencing and dynamic linking. * Comprehensively reviews - for the first time in one single work - the strategies, technologies, principles and applications of modern medicinal chemistry * Provides a global and current perspective of today's drug discovery process and discusses the major therapeutic classes and targets * Includes a unique collection of case studies and personal assays reviewing the discovery and development of key drugs

Remington

Remington Book
Author : Joseph Price Remington,Alfonso R. Gennaro
Publisher : Lippincott Raven
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

For more than 100 years, this textbook has been the definitive reference for all aspects of the science and practice of pharmacy, and is used for pharmaceutics, therapeutics and pharmacy practice courses in primary curricula. Since the first edition was published, pharmacists have used this book as a key one-stop reference. This updated edition covers many education and practice issues, from the history of pharmacy and ethics, to industrial pharmacy and pharmacy practice. New to the edition are expanded sections on pharmacy administration and patient care, which include new topics such as: nutrition in pharmacy practice; self care and home diagnostic products; health care delivery systems and interdisciplinary care; and home health patient care. Also, information has been condensed into one volume for greater portability and convenience.

Early Phase Drug Evaluation in Man

Early Phase Drug Evaluation in Man Book
Author : O'grady
Publisher : CRC Press
Release : 2020-02-03
ISBN : 1000725596
Language : En, Es, Fr & De

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Book Description :

Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

Clinical and Experimental Hypertension

Clinical and Experimental Hypertension Book
Author : Anonim
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Clinical and Experimental Hypertension book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.