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Idea to Product

The Process

  • Book
  • © 1996

Overview

Editors:
  1. Nancy J. Alexander

    1. National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, USA

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  2. Anne Colston Wentz

    1. National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, USA

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    You can also search for this editor in PubMed   Google Scholar

Part of the book series: Serono Symposia USA (SERONOSYMP)

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Table of contents (27 chapters)

  1. Front Matter

    Pages i-xv
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  2. Introduction

    1. Front Matter

      Pages 1-1
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    2. The Preclinical Research Process

      • James S. Hutchison
      Pages 3-4

    3. The Commercial Development Process

      • Stan Bernard
      Pages 5-6

  4. Details of Drug Development

    1. Front Matter

      Pages 45-45
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    2. Role of Toxicology in Drug Discovery and Development

      • Robin S. Goldstein
      Pages 47-48

    3. Pharmacokinetics Study

      • Leslie Z. Benet
      Pages 49-49

    4. Formulation of Dosage Forms

      • Ralph F. Shangraw
      Pages 51-51

    5. Polymeric Drug Delivery Systems

      • Robert S. Langer
      Pages 53-67

    6. What Is a Drug, a Device, a Biological?

      • Susan Alpert
      Pages 69-72

  5. Negotiating the System

    1. Front Matter

      Pages 73-73
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    2. Understanding the Organization and Function of the FDA

      • Lisa D. Rarick
      Pages 75-79

    3. How to Apply for an IND

      • Hanni Levi Ellis
      Pages 81-86

    4. What Is a 510(k) and a PMA?

      • Lillian L. Yin
      Pages 87-96
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Keywords

About this book

The young investigator with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market. Nowhere is described the steps in the development of new drugs, diagnos­ tics, or devices; the person with an idea has nowhere to turn for information and details. The young investigator may understand the elements of basic and clinical research, but ordinarily has no insight into novel ways of finding research funding or how to explore to find the funding opportunities that are available. The young investigator has little knowledge of the mecha­ nisms to bring an idea through the developmental phases to the market. There are other players in this complex endeavor with whom he or she has no contact, including those from industry, the Food and Drug Administration, and the legal community. Exposure to the philosophy of product develop­ ment and to procedural information would be useful to the scientific com­ munity, as would contact with those who have successfully taken an idea to a finished product. A first attempt to do this was the symposium on Idea to Product: The Process, sponsored by Serono Symposia USA and held No­ vember 17 to 20, 1994, in Washington, D.C. This book comprises the pro­ ceedings of that meeting. The editors are indebted to the many contributors to this volume, and we are especially grateful to Serono Symposia USA and to Leslie Nies and her staff for their expertise in organizing the symposium.

Editors and Affiliations

  • National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, USA

    Nancy J. Alexander, Anne Colston Wentz

Bibliographic Information

  • Book Title: Idea to Product

  • Book Subtitle: The Process

  • Editors: Nancy J. Alexander, Anne Colston Wentz

  • Series Title: Serono Symposia USA

  • DOI: https://doi.org/10.1007/978-1-4612-0743-6

  • Publisher: Springer New York, NY

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer-Verlag New York, Inc. 1996

  • Hardcover ISBN: 978-0-387-94742-6Published: 27 September 1996

  • Softcover ISBN: 978-1-4612-6889-5Published: 21 October 2012

  • eBook ISBN: 978-1-4612-0743-6Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: XV, 200

  • Topics: Medicine/Public Health, general, Biomedical Engineering and Bioengineering

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