Preclinical Development Handbook, 2-Volume Set

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Release : 2008-03-14
Genre : Medical
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Book Rating : 833/5 ( reviews)

Preclinical Development Handbook, 2-Volume Set - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Preclinical Development Handbook, 2-Volume Set write by Shayne Cox Gad. This book was released on 2008-03-14. Preclinical Development Handbook, 2-Volume Set available in PDF, EPUB and Kindle. This book brings together in one resource an overview of the preclinical process along with a compendium of methods and techniques that need to be considered when developing a new drug. The book details steps in the preclinical process including: prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, toxicity, modeling, and regulations. It includes problems that are encountered, solutions to these problems, and limitations of various methods and techniques used in determining the safety and efficacy of a drug at this stage.

Preclinical Development Handbook

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Release : 2008-03-21
Genre : Medical
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Book Rating : 021/5 ( reviews)

Preclinical Development Handbook - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Preclinical Development Handbook write by Shayne Cox Gad. This book was released on 2008-03-21. Preclinical Development Handbook available in PDF, EPUB and Kindle. 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, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is 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 has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions 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 publication should be readily accessible to all 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.

Early Drug Development, 2 Volume Set

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Release : 2018-12-10
Genre : Science
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Book Rating : 498/5 ( reviews)

Early Drug Development, 2 Volume Set - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Early Drug Development, 2 Volume Set write by Fabrizio Giordanetto. This book was released on 2018-12-10. Early Drug Development, 2 Volume Set available in PDF, EPUB and Kindle. 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.

Evaluation of Drug Candidates for Preclinical Development

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Release : 2010-01-19
Genre : Medical
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Book Rating : 918/5 ( reviews)

Evaluation of Drug Candidates for Preclinical Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Evaluation of Drug Candidates for Preclinical Development write by Chao Han. This book was released on 2010-01-19. Evaluation of Drug Candidates for Preclinical Development available in PDF, EPUB and Kindle. 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.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

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Release : 2012-11-02
Genre : Business & Economics
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Book Rating : 152/5 ( reviews)

A Comprehensive Guide to Toxicology in Preclinical Drug Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook A Comprehensive Guide to Toxicology in Preclinical Drug Development write by Ali S. Faqi. This book was released on 2012-11-02. A Comprehensive Guide to Toxicology in Preclinical Drug Development available in PDF, EPUB and Kindle. A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --