Regulatory Focus - September 2008

Where is our profession headed?

A Seat at the Table:Regulatory in Corporate Health care

Managing Global Business Risk:The New Role of Regulatory Leaders

Mergers, Acquisitions and Operational Risk

The Regulatory Professional:A Jack of All Trades

Regulating Nanotechnology in the US & EU

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In Silico Technologies in Drug Target Identification and Validation

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The pharmaceutical industry relies on numerous well-designed experiments involving high-throughput techniques and in silico approaches to analyze potential drug targets. These in silico methods are often predictive, yielding faster and less expensive analyses than traditional in vivo or in vitro procedures. In Silico Technologies in Drug Target Identification and Validation addresses the challenge of testing a growing number of new potential targets and reviews currently available in silico approaches for identifying and validating these targets. The book emphasizes computational tools, public and commercial databases, mathematical methods, and software for interpreting complex experimental data. The book describes how these tools are used to visualize a target structure, identify binding sites, and predict behavior. World-renowned researchers cover many topics not typically found in most informatics books, including functional annotation, siRNA design, pathways, text mining, ontologies, systems biology, database management, data pipelining, and pharmacogenomics. Covering issues that range from prescreening target selection to genetic modeling and valuable data integration, In Silico Technologies in Drug Target Identification and Validation is a self-contained and practical guide to the various computational tools that can accelerate the identification and validation stages of drug target discovery and determine the biological functionality of potential targets more effectively.

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New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

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Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

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Design of Controlled Release Drug Delivery Systems

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The goal of every drug delivery system is to deliver the precise amount of a drug at a pre-programmed rate to the desired location in order to achieve the drug level necessary for the treatment. An essential guide for biomedical engineers and pharmaceutical designers, this resource combines physicochemical principles with physiological processes to facilitate the design of systems that will deliver medication at the time and place it is most needed.

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Nanoparticulates As Drug Carriers

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Written by key experts in the field of nanomedicine, this book provides a broad introduction to the important field of nanomedicine and application of nanotechnology for drug delivery. It covers up-to-date information regarding various nanoparticulate drug delivery systems, describes the various opportunities for the application of nanoparticular drug carriers in different areas of clinical medicine, and analyzes already available information on their clinical applications. This book can be used as an advanced textbook by graduate students and young scientists and clinicians at the early stages of their career. It is also suitable for non-experts from related areas of chemistry, biochemistry, molecular biology, biomedical engineering, physiology, experimental and clinical medicine, and pharmaceutical sciences, who are interested in general problems of drug delivery and drug targeting, as well as in more specialized topics of using nanoparticulate-mediated drug delivery approaches in the individual areas of clinical medicine. Prof Torchilin is an expert in Nanomedicine and a recipient of numerous awards including the Lenin Prize in Science Technology of the former USSR, membership in the European Academy of Sciences, and AAPS Research Achievement Award in Pharmaceutics and Drug Delivery. He served as an Associate Professor of Radiology at Harvard Medical School before joining Northeastern University as the Chairman of the Department of Pharmaceutical Sciences.

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Encyclopedia of Controlled Drug Delivery, 2 Volume Set

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Covers all aspects of controlled drug delivery, including human, agricultural and animal applications. The 70 entries, written by an international team of renowned experts, offers A-to-Z coverage of controlled drug delivery systems for researchers in the pharmaceutical and biotechnology industries, agriculture companies, medical device companies, clinical research organizations and medical schools.

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