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CRC Press New Drug Development - Regulatory Paradigms 141

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Description

Navigate the complexities of pharmaceutical development with this essential guide from CRC Press. New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics provides a clear roadmap for those entering the pharmaceutical field. By focusing on the latest regulatory requirements, this book helps professionals understand the necessary steps to move from concept to approval. This volume helps you reduce development costs by teaching you how to avoid unnecessary trials. It offers practical guidance through every stage of the drug approval process, using updated guidelines from the FDA and ICH. You will find solutions to common hurdles in application protocols and gain insights from more than 40 respected and experienced regulatory officials. Whether you are managing a project or studying the field, this book provides the technical foundation needed to determine the success of your drug development projects.

Key Features

Learn to navigate the drug approval process using updated regulatory guidelines from the FDA and ICH.

Reduce development costs by learning how to avoid unnecessary clinical trials through better planning.

Gain expert solutions to common hurdles encountered in application protocols during development.

Access recommendations and insights from more than 40 experienced and respected regulatory officials.

Understand the specific regulatory steps required for successful clinical pharmacology and biopharmaceutics projects.

This is a used book in good condition, making it a practical resource for pharmacy and medical professionals.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
24 May 2004
Listed Since
02 February 2007

Barcode

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