Idea to Product

1. Front Matter

   Pages i-xv

   PDF

2. Introduction

   1. Front Matter

      Pages 1-1

      PDF

   2. The Preclinical Research Process

      • James S. Hutchison

      Pages 3-4

   3. The Commercial Development Process

      • Stan Bernard

      Pages 5-6

3. Getting Started

   1. Front Matter

      Pages 7-7

      PDF

   2. What’s Involved in Clinical Research?

      • Samuel A. Pasquale

      Pages 9-16

   3. Product Development Partnership: Role of Academia and the NIH

      • Gary D. Hodgen

      Pages 17-20

   4. Identifying Funding Opportunities at the NIH: A Grants Perspective

      • Melinda B. Nelson

      Pages 21-23

   5. Identifying Funding Opportunities at the NIH: A Contract Perspective

      • Richard A. Wagner

      Pages 25-31

   6. Role of the Institution in Furthering the Young Investigator

      • David A. Blake

      Pages 33-44

4. Details of Drug Development

   1. Front Matter

      Pages 45-45

      PDF

   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

      PDF

   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

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.

• assessment
• clinical research
• clinical trial
• diagnostics
• drug
• drug delivery
• drug development
• drug discovery
• kinetics
• medicine
• pharmacokinetics
• planning
• research
• safety
• toxicology

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

  Nancy J. Alexander, Anne Colston Wentz

Policies and ethics