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.
