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Building a National Framework for the Establishment of Regulatory Science for Drug Development

enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010;

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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or;

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Advancing Regulatory Science for Medical Countermeasure Development

use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the;

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Innovative Statistics in Regulatory Science

. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are;

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Innovative Statistics in Regulatory Science

. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are;

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International Regulatory Harmonization Amid Globalization of Drug Development

the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development;

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Drug-Drug Interactions in Pharmaceutical Development

Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory;

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Building EU Regulatory Capacity

contribution by developing a bureaucratic politics perspective that highlights the importance of national regulators for EU regulatory capacity;

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Building EU Regulatory Capacity

contribution by developing a bureaucratic politics perspective that highlights the importance of national regulators for EU regulatory capacity;

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Building Genetic Medicine

A comparative study of genetic testing for breast and ovarian cancer in the United States and Britain that shows the importance of national;

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Stronger Food and Drug Regulatory Systems Abroad

of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality;

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Nuclear Security Systems and Measures for the Detection of Nuclear and Other Radioactive Material out of Regulatory Control

security systems and measures, and is based on an appropriate legal and regulatory framework for the implementation of the national detection;

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Nuclear security systems and measures for the detection of nuclear and other radioactive material out of regulatory control

security systems and measures, and is based on an appropriate legal and regulatory framework for the implementation of the national detection;

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Nuclear Security Systems and Measures for the Detection of Nuclear and Other Radioactive Material out of Regulatory Control

security systems and measures, and is based on an appropriate legal and regulatory framework for the implementation of the national detection;

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Generic Drug Product Development

legislative and regulatory requirements for the registration of generic and multi-source drug products.;

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Generic Drug Product Development

legislative and regulatory requirements for the registration of generic and multi-source drug products.;

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Bayesian Analysis with R for Drug Development

data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake;

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Bayesian Analysis with R for Drug Development

data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake;

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Theory of Drug Development

Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing;

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Theory of Drug Development

Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing;

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Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda

infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National;

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Interface between Regulation and Statistics in Drug Development

: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the;

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Interface between Regulation and Statistics in Drug Development

: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the;

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Biosimilars

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for;

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Real-World Evidence in Drug Development and Evaluation

field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range;

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Good Drug Regulatory Practices

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national;

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Generic Drug Product Development

for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.;

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