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New Drug Approval Process

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect;

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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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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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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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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental;

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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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Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration;

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FDA Regulatory Affairs

Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides;

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Drug Delivery Nanoparticles Formulation and Characterization

Exploring fundamental concepts, Drug Delivery Nanoparticles Formulation and Characterization presents key aspects of nanoparticulate system;

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Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition

provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production;

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Clinical Drug Trials and Tribulations, Revised and Expanded

Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the;

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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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Pharmaceutical Dosage Forms

pharmaceutical excipients. It explains the requirements for conducting clinical research and obtaining marketing approval for new drug products;

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New Drug Discovery And Development

A case history approach to drug synthesis and discovery Discover the origins of some of today's most popular drug therapies. Explore case;

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Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies

The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical;

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Emerging Safety Science

In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to;

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Transdermal Drug Delivery

of drug permeability to available enhancement technolgies, to regulatory approval.;

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Transdermal Drug Delivery

of drug permeability to available enhancement technolgies, to regulatory approval.;

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The Future of Drug Safety

problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety;

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Pharmacoepidemiology and Pharmacovigilance

safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for;

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NURSES POCKET DRUG GUIDE 2009

information on the selection and administration of 1,000 commonly used medications.This resource is revised annually to reflect approval of new drugs;

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The Pharmaceutical Regulatory Process

companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA;

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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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Theory of Drug Development

marketing approval based on its phase 2/3 development program and recent experience with other drugs in the same clinical area Determining the;

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Theory of Drug Development

marketing approval based on its phase 2/3 development program and recent experience with other drugs in the same clinical area Determining the;

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Medicinal Chemistry

initial lead to the approval process, and include drug discovery sources. Additional features: Explains medicinal chemistry on;

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