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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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Analytical Method Development and Validation

validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)International;

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New Drug Approval Process

in international regulatory requirements, including ICH guidelines and harmonization a step-by-step format for content, assembly, and strategic approach;

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Principles and Practice of Pharmaceutical Medicine

medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic;

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FDA Regulatory Affairs

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device;

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Drug Policy Harmonization and the European Union

Exploring the illegal drug issue in international context, this book looks at why harmonization has not already taken place at the European;

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FDA Regulatory Affairs

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain;

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Food and Drug Regulation in an Era of Globalized Markets

approach allows readers to understand the varying perspectives involved in regulatory developmentIncludes case studies to highlight;

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Development and Evaluation of Drugs

drugs to market, including activities of the International Commission on Harmonization.;

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Anti-Drugs Policies of the European Union

networks of expertise. Policy development is placed in the context of both European integration and a broad harmonization of international policies;

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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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New Drug Development

Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical;

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete;

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Civil Litigation in a Globalising World

legislative and practical developments both at the European and the global level. This book discusses the globalization and harmonization of civil;

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Generic Drug Product Development

international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic;

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Generic Drug Product Development

international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic;

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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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Patent Cultures

This book explores how dissimilar patent systems remain distinctive despite international efforts towards harmonization. The dominant;

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Global Divergence in Trade, Money and Policy

special interest in globalization, development and international trade.;

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Quick Guide to Good Clinical Practice

international quality standard - Good Clinical Practice - provided by the International Conference on Harmonization (ICH). The work offers an;

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

The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong;

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Perspectives and guidelines on food legislation, with a new model food law

The increasing globalization of food trade and the harmonization of food standards and food safety rules have led to significant changes;

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Innovative Methods for Rare Disease Drug Development

protocols such as platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development such as gene therapy.;

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Innovative Methods for Rare Disease Drug Development

protocols such as platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development such as gene therapy.;

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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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