Idea to Product : the Process (eBook, 1996) [WorldCat.org]
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Idea to Product : the Process

Author: Nancy J Alexander; Anne Colston Wentz
Publisher: New York, NY : Springer New York, 1996.
Series: Serono Symposia USA.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
The young investor with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market and has little knowledge of the steps in the development of new drugs, diagnostics, or devices. This volume contains the proceedings of the Symposium on Idea to Product: The Process, held in Washington D.C. from November 17 - 20, 1994. Written and edited by eminent authorities  Read more...
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Details

Genre/Form: Electronic books
Additional Physical Format: Print version:
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Nancy J Alexander; Anne Colston Wentz
ISBN: 9781461207436 1461207436
OCLC Number: 853271091
Description: 1 online resource (xv, 200 pages)
Contents: I. Introduction --
1. The Preclinical Research Process --
2. The Commercial Development Process --
II. Getting Started --
3. What's Involved in Clinical Research? --
4. Product Development Partnership: Role of Academia and the NIH --
5. Identifying Funding Opportunities at the NIH:A Grants Perspective --
6. Identifying Funding Opportunities at the NIH:A Contract Perspective --
7. Role of the Institution in Furthering the Young Investigator --
III. Details of Drug Development --
8. Role of Toxicology in Drug Discovery and Development --
9. Pharmacokinetics Study --
10. Formulation of Dosage Forms --
11. Polymeric Drug Delivery Systems --
12. What Is a Drug, a Device, a Biological? --
IV. Negotiating the System --
13. Understanding the Organization and Function of the FDA --
14. How to Apply for an IND --
15. What Is a 501(k) and a PMA? --
16. Patenting and Licensing: An Overview of the Processes --
V. Clinical Investigation --
17. Pharmaceutical Clinical Development --
18. FDA Recommendations for Drug Safety Testing --
19. Decision Strategies in Assessment of Reproductive and Developmental Toxicology: A Paradigm for Safety Evaluation --
20. What Is Involved in a New Drug Application? --
21. Institutional Review Boards and Informed Consent --
22. Postmarketing Surveillance. A Brief Synopsis of Its History and Current Direction --
VI. Business Issues --
23. I Had an Idea, and I Made It Work: Here's How --
24. Working with Companies to Market Your Discoveries --
25. Developing Information for Health-Care Decision Makers --
26. Getting a Medical Products Business Started --
27. From Start-Up to Initial Public Offering --
Author Index --
Subject Inde.
Series Title: Serono Symposia USA.
Responsibility: edited by Nancy J. Alexander, Anne Colston Wentz.

Abstract:

The young investigator with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market.  Read more...

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