| This week's FierceBiotech is brought to you by RHO. |
This presentation will review help you understand the Target Product Profile and the Integrated Product Development Plan.
| | | |
Hi Reader, Do you think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step? Two documents you need at an early stage are the Target Product Profile (TPP), which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP), which describes the activities required through approval of your marketing application.
Why engage in these early stage activities when only 10-20% of products in clinical development make it to the market? By providing a framework of go/no go decision points that allow you to use accumulating data to assess the likelihood of product success, these documents make it possible to make key development decisions. This presentation reviews the content of both the TPP and the IPDP, demonstrates how they are written, and provides specific examples of decisions that are made as a result of the use of these documents. We hope you find this presentation helpful, and please contact us if you'd like to speak to one of our regulatory experts. Sincerely, Joan Parks
Joan_Parks@rhoworld.com
919-595-6626
www.rhoworld.com
@rhoworld
|
| | | | |
|
| | |
|
| Want to reach 160,000+ FierceBiotech subscribers with your own message?
Contact aalcover@fiercemarkets.com or call 202-824-5074.
About this email: In order to receive FierceBiotech for free, we ask that you accept an occasional email promotion from our sponsors. We carefully screen each promotion and never sell or give away your personal information. If you do not want to receive these messages, you can unsubscribe entirely from FierceBiotech.
Click here to unsubscribe.
FierceMarkets 1900 L St. NW Suite we 400 Washington, DC 20036 |
.
