What's the Regulatory Value of a Target Product Profile?

Christopher D. Breder; Wenny Du; Adria Tyndall

doi:10.1016/j.tibtech.2017.02.011

What's the Regulatory Value of a Target Product Profile?

Christopher D. Breder, Wenny Du, Adria Tyndall

School of Medicine

Research output: Contribution to journal › Comment/debate › peer-review

8 Scopus citations

Abstract

Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog.

Original language	English (US)
Pages (from-to)	576-579
Number of pages	4
Journal	Trends in Biotechnology
Volume	35
Issue number	7
DOIs	https://doi.org/10.1016/j.tibtech.2017.02.011
State	Published - Jul 2017

Keywords

product development
target product profile
time to market

ASJC Scopus subject areas

Biotechnology
Bioengineering

Access to Document

10.1016/j.tibtech.2017.02.011

Cite this

@article{f68af9fdc7914edab2f3e4c681abd578,

title = "What's the Regulatory Value of a Target Product Profile?",

abstract = "Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog.",

keywords = "product development, target product profile, time to market",

author = "Breder, {Christopher D.} and Wenny Du and Adria Tyndall",

note = "Publisher Copyright: {\textcopyright} 2017",

year = "2017",

month = jul,

doi = "10.1016/j.tibtech.2017.02.011",

language = "English (US)",

volume = "35",

pages = "576--579",

journal = "Trends in Biotechnology",

issn = "0167-7799",