Lifecycle Management Through the Rx-to-OTC Switch (e-book)
Table of Contents
Chapter 1: The Importance of Rx-to-OTC Switch to Consumer Self-Care
Chapter 2: Why Switch? Evaluating the Value of Switch Candidates
Chapter 3: What is the Rx-to-OTC switch process in the US and how does FDA regulate switches
Chapter 4: Plan B Case Study: A Story of Politics Over Science
Chapter 5: Prilosec OTC: A Case Study
Chapter 6: The History and Future of Rx-to-OTC Switch for Lipid Management in the US
Chapter 7: Review of the Rx-to-OTC Switch of Oxytrol for Women
Chapter 8: Differin Gel OTC Switch: Bringing Innovation to a Well-Established Category
Chapter 9: Intranasal Corticosteroids for Allergy OTC Switch: A US Case Study
Chapter 10: EU and RoW Switches
Chapter 11: Conclusion
Robert Falcone, PhD, FRAPS, editor
About the Book
Available formats: print and e-book
The increased relevance of over-the-counter (OTC) and self-care products to consumers and patients was the impetus for the development of Lifecycle Management Through the Rx-to-OTC Switch, the new, practical reference manual from RAPS.
The availability of OTC medicine provides significant value to the US healthcare system relative to prescription alternatives. The market is expected to grow exponentially over the next several years creating new commercial opportunities for pharmaceutical manufacturers and exposing a need for an easy to understand, practical resource for regulatory professionals who need to plan, manage, and execute a successful switch program.
Through a series of case studies, Lifecycle Management Through the Rx-to-OTC Switch will guide readers through the basic requirements for implementing a switch to increase availability of, access to, and adoption of OTC medications. This comprehensive manual is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Who will benefit from this book?
Lifecycle Management Through the Rx-to-OTC Switch was developed for regulatory professionals of all levels, including newcomers and seasoned professionals, ranging from those working in product development and marketing to those in regulatory affairs. This book is a valuable resource for any regulatory professional interested in learning about or pursuing a switch.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2021. Paperback. 202 pages. ISBN (print): 978-1-947493-71-1. ISBN (digital): 978-1-947493-72-8.
