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Expediting Drug and Biologics Development: A Strategic Approach 2006
Barnett Educational Services
February 1, 2006 340 Pages - SKU: BNT1870217
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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.
In addition, Expediting Drug and Biologics Development 2006 will provide you with direct access to the expertise and recommendations of dozens of the most experienced and forward-thinking experts in the pharmaceutical and biotechnology industries today.
Please note: The delivery of this report requires Adobe 6 or higher, and the ability to install right management plugin for Adobe.
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- 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
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