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The Future of Drug Safety

Acronyms Appendix C PDUFA Performance Goals-All Years Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas;

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Halcion

and efficacy of Halcion (triazolam)?a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch;

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Quantitative Evaluation of Safety in Drug Development

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative;

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Food and Drug Administration Advisory Committees

Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory;

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Enhancing Food Safety

recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP;

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Excipient Toxicity and Safety

United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment;

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Excipient Toxicity and Safety

United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment;

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Drugs and the FDA

made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug’s safety and;

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FDA Regulatory Affairs

of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research;

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Nonclinical Safety Assessment

Providing a comprehensive, international overview of the regulatory requirements for safety assessment for new drug approvals, each chapter;

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Immunotoxicology Strategies for Pharmaceutical Safety Assessment

toxic impacts (bio)pharmaceuticals can have on the immune system* Includes chapter authors from across the pharma industry, bringing a real;

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs

drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs;

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Cobert's Manual Of Drug Safety And Pharmacovigilance

Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the;

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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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Civil Aircraft Electrical Power System Safety Assessment

continuous safety assessment process of the civil airborne electrical power system, this book addresses problems, issues and troubleshooting;

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Prescribed Medications and the Public Health

documenting adverse drug events. National and local plans are explored to help achieve the essential goal of greater safety throughout the system. The;

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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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Drug Safety and Pharmacoepidemiology

Pharmacoepidemiology is concerned with the study of the uses of drugs and their effects in specific populations. It builds on the;

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Predictive Toxicology in Drug Safety

collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side;

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Ensuring Safe Food

new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that;

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Histopathology of Preclinical Toxicity Studies

drug-induced pathologies and applicable species comparisons to aid in the preclinical safety assessment of new medicines. This updated;

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System Safety Engineering and Risk Assessment

comprehensive and easily accessible guide on how to build safety into products as well as into industrial processes. Using a systems approach, the text;

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Medication Safety

Medication Safety Team, Building a Safe Medication Use System, and Measuring Medication Safety. Chapters include information on: Business and;

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Reusable Booster System

program. The committee for the Reusable Booster System: Review and Assessment was formed in response to that request and charged with reviewing;

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High-Throughput Screening Methods in Toxicity Testing

detailed information on data generation, data analysis, and applications in risk assessment. The topic is especially timely given Europe's REACH;

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Review of NASA's Aerospace Technology Enterprise

Airspace Systems Program, and the Aviation Safety Program. To conduct this review, the NRC established three panels, one for each of the component;

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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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