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Research (R&D)

Expediting Drugs and Biologics Development

A Strategic Approach 2006

Publication Date   February 2006
Publisher   Barnett International
Product Type   Book
Pages   340
ISBN Number   not applicable
Product Code   BAR018
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Price £80.00

approximately: $149 | €101

Summary


Using a unique "reverse-engineering" approach, dozens of leading experts with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to expedite even the most complex product development programs today!

From the first preclinical testing to clinical trials to the NDA/BLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a development program's design and implementation.

The new third edition of Expediting Drug and Biologics Development is not a summary of U.S. or international regulatory requirements. Rather, it is a real-world "doer's" guide to drug and biologics development. It provides dozens of templates, forms, and tools to assists those "in the trenches" of new drug and biologic development today.

With this book, you will learn how to:
• apply the very latest and most advanced project management techniques directly to challenges presented by the drug development process.
• critically evaluate the needs of the package insert and marketing application up front, before getting deeply into clinical trials.
• leverage standardization to drive and expedite the entire development process, from the development of clinical trial protocols to the development of clinical data presentations.
• critically assess the needs of the final report before developing the clinical protocol.
• use draft case report forms (CRF) to dictate the content of the procedures section of the clinical protocol.
• constructively consider the methods for data analysis in developing the clinical protocol.

Content


Chapter 1. Beginning at the Destination: A Corporate Culture

Chapter 2. Project Management and Pharmaceutical Development

Chapter 3. Integration of CMC into Drug Development: Avoiding the Common Delays

Chapter 4. Nonclinical Development

Chapter 5. Clinical Development Plans: Target Product Profile

Chapter 6. Information Systems in Support of Pharmaceutical Development

Chapter 7. Title 21 CFR Part 11

Chapter 8. Format and Content of the Common Technical Document (CTD)

Chapter 9. Streamlining the Drug Development and Approval Process

Chapter 10. Meeting with the FDA

Chapter 11. The Investigational New Drug Application

Chapter 12. The Investigator’s Brochure

Chapter 13. The Phases of Clinical Development

Chapter 14. Clinical Trials Enrolling Children

Chapter 15. Clinical Study Reports

Chapter 16. Standard Data Presentations

Chapter 17. Analysis Plans

Chapter 18. Data Capture

Chapter 19. The Clinical Protocol

Chapter 20. Informed Consent and IRB Review

Chapter 21. Clinical Trial Operations

Chapter 22. Clinical Monitoring

Chapter 23. An Integrated Approach to Data Management

Chapter 24. Evaluation of Safety During Clinical Drug Development

Chapter 25. Developing a Risk Minimization Action Plan

Chapter 26. Assembling and Filing the Common Technical Document

Chapter 27. The FDA Marketing Application Review Process

Chapter 28. Preparing for FDA Inspection

Chapter 29. Preparing for an FDA Advisory Committee Meeting

Chapter 30. Post-Marketing Safety Assessment