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Quantitative Evaluation of Safety in Drug Development

Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both;

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Evaluation of Drug Candidates for Preclinical Development

sections on pharmacokinetics and drug metabolism, integration of pharmaceutical development, and predictive safety assessment. Topics include: cost;

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Imaging in Drug Discovery and Early Clinical Trials

bioavailability and efficacy, and during drug safety evaluation.;

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Drug Delivery Applications of Noninvasive Imaging

This book overviews in vivo imaging techniques for both the development of drug delivery systems and controlled release dosages. Written by;

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Analysis of Drug Impurities

drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the;

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Quantitative Evaluation of Systems

This book constitutes the proceedings of the 17th International Conference on Quantitative Evaluation Systems, QEST 2020, held in Vienna;

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International Regulatory Harmonization Amid Globalization of Drug Development

development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and;

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Accelerating the Development of Biomarkers for Drug Safety

safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development;

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Statistics in Drug Research

establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug;

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Statistics in Drug Research

establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug;

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Preclinical Safety Evaluation of Biopharmaceuticals

responsibilities include the evaluation of novel therapies. --From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the;

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Drug Safety in Developing Countries

Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing;

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Leachables and Extractables Handbook

. This book describes the development and application of safety thresholds for Orally Inhaled and Nasal Drug Products (OINDP). It discusses best;

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Safety Pharmacology in Pharmaceutical Development

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired;

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Drug-Induced Mitochondrial Dysfunction

This is the definitive, one-stop resource on preclinical drug evaluation for potential mitochondrial toxicity, addressing the issue upfront;

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Toxicologic Pathology

been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an;

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Drug Discovery and Development, Third Edition

areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical;

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Genomics in Drug Discovery and Development

personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.;

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Cardiac Drug Safety: A Bench To Bedside Approach

safety signal on drug development, is a complete understanding of how these events may arise, what cardiac safety tests are currently used, and;

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Pharmacoepidemiology and Pharmacovigilance

safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for;

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Drug Design Strategies

. After an overview of quantitative approaches to drug design the book describes the development of concepts of drug-like properties;

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Safety Evaluation in the Development of Medical Devices and Combination Products

worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug;

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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed;

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Principles of CNS Drug Development

. The book outlines the core processes in drug discovery and development for CNS disorders, from evaluating drugs for desirable efficacy, safety;

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PET for Drug Development and Evaluation

Can drug development and evaluation be improved by the use of positron emission tomography (PET)? PET is now well established and many;

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Emerging Safety Science

because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could;

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Drug Efficacy, Safety, and Biologics Discovery

Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools covers key emerging technologies in pharmaceutical R & D;

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