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Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies

consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient;

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FDA Drug Approval

The Food and Drug Administration (FDA) oversees the approval and regulation of drugs entering the U.S. market. Two regulatory frameworks;

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Antibody Therapeutics

preclinical and clinical data acquired during the regulatory approval process. Leading experts offer their findings as examples of what works and what;

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Experimentalist Regional Governance

affected, and the institutions involved change over time. The presented research provides a decision-making concept for such situations. Based on a;

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Promoting the Growth and Development of Smallholder Seed Enterprises for Food Security Crops

publication aims at raising the awareness of decision makers and provides guidelines of best practices and policy options for promoting and supporting;

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Innovative Statistics in Regulatory Science

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as;

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Innovative Statistics in Regulatory Science

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as;

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New Drug Approval Process

in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for;

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Health Technology Assessment: Using Biostatistics to Break the Barriers of Adopting New Medicines

shortcomings of submissions for drug and device reimbursement. The book begins by contrasting the differences between regulatory approval and;

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Health Technology Assessment: Using Biostatistics to Break the Barriers of Adopting New Medicines

shortcomings of submissions for drug and device reimbursement. The book begins by contrasting the differences between regulatory approval and;

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Legislation on Water Users' Organizations

A robust regulatory framework for the corporate governance of water users' organizations is a fundamental ingredient of irrigation;

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Enhancing Food Safety

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring;

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Advancing Regulatory Science for Medical Countermeasure Development

decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop;

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How to Integrate Quality by Efficient Design (QbED) in Product Development

strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as;

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Distributed Decision Making

decision making, draws on current academic and case history information, and highlights the need for better theories, improved research methods and;

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FDA Regulatory Affairs

development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system;

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Pharmaceutical Analysis for Small Molecules

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical;

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Conventional and Advanced Food Processing Technologies

Food processing technologies are an essential link in the food chain. These technologies are many and varied, changing in popularity with;

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Food, People and Society

A unique insight into the decision-making and food consumption of the European consumer. The volume is essential reading for those involved;

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Food, People and Society

A unique insight into the decision-making and food consumption of the European consumer. The volume is essential reading for those involved;

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Preparing for FDA Pre-Approval Inspections

, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval;

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BenefitRisk Appraisal of Medicines

Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine;

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Organizational Learning in the Age of Data

This book discusses the impact of advanced information technologies, such as data processing, machine learning, and artificial intelligence;

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Organizational Learning in the Age of Data

This book discusses the impact of advanced information technologies, such as data processing, machine learning, and artificial intelligence;

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Translational Admet For Drug Therapy

interpretation, and decision-making tactics for pharmaceutical and preclinical scientists. Chapters cover case studies and in vivo, in vitro, and;

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Nanomaterials for Food Applications

of ingredients in nanoform to improve bioavailability or nanoencapsulation technologies, nanotechnologies for food processing, nanosensors for food;

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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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