Target Product Profile: A Planning Tool for the Drug Development

Abstract

Drug development is a very expensive and time consuming process. Industries develop a tool known as Target Product Profile (TPP), which is simply a planning tool for the development of a drug candidate from discovery to clinical development programs. This establishes safety, efficacy, and marketing suitability of the drug. FDA issued guidance on TPP for better communication between the sponsor and regulatory agencies, with an emphasis of drug development towards intended labeling content and promotional claims. It lacks insight towards marketing viability of the development program. To get marketing success, Industries incorporated strategies within the framework of FDA guidance. Such strategies having three components: a. Target market profile, the foundation of framework. b. Strategies target profile, the steps for reaching marketplace. c. Target product profile for market launching. This framework guides the clinical development decisions and builds the foundations for commercial success.