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
[email protected]
919-595-6626
www.rhoworld.com
@rhoworld