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Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine Paperback – May 1, 2010


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Product Details

  • Paperback: 344 pages
  • Publisher: Logos Press (May 1, 2010)
  • Language: English
  • ISBN-10: 1934899127
  • ISBN-13: 978-1934899120
  • Product Dimensions: 9 x 6 x 0.7 inches
  • Shipping Weight: 1.1 pounds (View shipping rates and policies)
  • Average Customer Review: 5.0 out of 5 stars  See all reviews (2 customer reviews)
  • Amazon Best Sellers Rank: #1,884,390 in Books (See Top 100 in Books)

Editorial Reviews

Review

This message couldn't come at a better time... Avellanet offers very practical tips on how to implement some of the sweeping changes in mindset that smart drug development and manufacturing require, in bite-sized steps. --Pharma QbD, May 22, 2010

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1 of 1 people found the following review helpful By Daniel J OLeary on September 24, 2010
Format: Paperback
For companies in regulated industries, there can be major problems with implementing the regulations and ensuring compliance. This is particularly true with areas the FDA regulates.

The FDA regulates a vast variety of products including fruit juice, laser light shows, aspirin, and tooth brushes. The complexity of drugs can range from basic aspirin tables to multifaceted drug regimens that may require individual patient genetic information to determine which form is more appropriate. On the device side, this can range from the basic tongue depressor to highly advanced MRI machines that help determine brain functions.

The regulatory structure tends be "old school" with a classic command and control structure, while the new business reality means moving quickly to address business issues. The two approaches create a dichotomy, but, with deep insight, this book creates a meaningful and practical synthesis. For example, the book discuses FDA's approach for electronic records and electronic signatures (21 CFR Part 11). The regulations haven't changed in at least 12 years, but computing power and capability double every 24 months (by Moore's Law).

One of the most valuable, and interesting, aspects of the book is the recognition of the similarity among four sets of FDA regulations: Drug development and manufacture in GMP, Device development and manufacture in QSR, Laboratory practices GLP, and Clinical process in GCP. Most approaches focus on the differences among these approaches. This book recognizes the similarities and demonstrates how executives can take advantage of these similarities to create new and stronger approaches. This kind of thinking offers shorter time to market, a reduced development cost, and stronger regulatory compliance.
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1 of 1 people found the following review helpful By Anita, and I'm a Mom on June 21, 2010
Format: Paperback
I'm in Regulatory and this book is exactly the tool you need to easily get into compliance for the 'new' FDA. It provides helpful hints and checklists that will help guide your steps. It not only provides a regulatory perspective, but shows you how all functional groups need to work together to ensure compliance across the board. Highly recommended for established and new organizations!
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