Idea to Product

The Process

Editors:

ISBN: 978-1-4612-6889-5 (Print) 978-1-4612-0743-6 (Online)

Table of contents (27 chapters)

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  1. Front Matter

    Pages i-xv

  2. Introduction

    1. Front Matter

      Pages 1-1

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      Book Chapter

      Pages 3-4

      The Preclinical Research Process

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      Book Chapter

      Pages 5-6

      The Commercial Development Process

  3. Getting Started

    1. Front Matter

      Pages 7-7

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      Book Chapter

      Pages 9-16

      What’s Involved in Clinical Research?

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      Pages 17-20

      Product Development Partnership: Role of Academia and the NIH

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      Book Chapter

      Pages 21-23

      Identifying Funding Opportunities at the NIH: A Grants Perspective

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      Book Chapter

      Pages 25-31

      Identifying Funding Opportunities at the NIH: A Contract Perspective

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      Book Chapter

      Pages 33-44

      Role of the Institution in Furthering the Young Investigator

  4. Details of Drug Development

    1. Front Matter

      Pages 45-45

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      Book Chapter

      Pages 47-48

      Role of Toxicology in Drug Discovery and Development

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      Pages 49-49

      Pharmacokinetics Study

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      Pages 51-51

      Formulation of Dosage Forms

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      Book Chapter

      Pages 53-67

      Polymeric Drug Delivery Systems

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      Book Chapter

      Pages 69-72

      What Is a Drug, a Device, a Biological?

  5. Negotiating the System

    1. Front Matter

      Pages 73-73

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      Book Chapter

      Pages 75-79

      Understanding the Organization and Function of the FDA

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      Book Chapter

      Pages 81-86

      How to Apply for an IND

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      Book Chapter

      Pages 87-96

      What Is a 510(k) and a PMA?

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      Book Chapter

      Pages 97-100

      Patenting and Licensing: An Overview of the Processes

  6. Clinical Investigation

    1. Front Matter

      Pages 101-101

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      Book Chapter

      Pages 103-114

      Pharmaceutical Clinical Development

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      Pages 115-118

      FDA Recommendations for Drug Safety Testing

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      Book Chapter

      Pages 119-131

      Decision Strategies in Assessment of Reproductive and Developmental Toxicology: A Paradigm for Safety Evaluation

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      Book Chapter

      Pages 133-139

      What Is Involved in a New Drug Application?

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