What's the Regulatory Value of a Target Product Profile?
Sign Up to like & getrecommendations! Published in 2017 at "Trends in biotechnology"
DOI: 10.1016/j.tibtech.2017.02.011
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… read more here.
Keywords: value target; regulatory value; product profile; target ... See more keywords
Modelling population-level impact to inform target product profiles for childhood malaria vaccines
Sign Up to like & getrecommendations! Published in 2018 at "BMC Medicine"
DOI: 10.1186/s12916-018-1095-6
Abstract: BackgroundThe RTS,S/AS01 vaccine for Plasmodium falciparum malaria demonstrated moderate efficacy in 5–17-month-old children in phase 3 trials, and from 2018, the vaccine will be evaluated through a large-scale pilot implementation program. Work is ongoing to… read more here.
Keywords: impact; efficacy; initial efficacy; vaccine ... See more keywords
Target product profile for a test for the early assessment of treatment efficacy in Chagas disease patients: An expert consensus
Sign Up to like & getrecommendations! Published in 2020 at "PLoS Neglected Tropical Diseases"
DOI: 10.1371/journal.pntd.0008035
Abstract: ISGlobal work is supported by the Departament d’Universitats i Recerca de la Generalitat de Catalunya, Spain (AGAUR; 017SGR00924) and by the Instituto de Salud Carlos III (ISCIII) RICET Network for Cooperative Research in Tropical Diseases… read more here.
Keywords: test early; product profile; health; dndi ... See more keywords
Diagnostics to support the eradication of yaws—Development of two target product profiles
Sign Up to like & getrecommendations! Published in 2022 at "PLoS Neglected Tropical Diseases"
DOI: 10.1371/journal.pntd.0010554
Abstract: Background: Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however,… read more here.
Keywords: product profiles; test; product; eradication ... See more keywords
Diagnostics to support the control of scabies–Development of two target product profiles
Sign Up to like & getrecommendations! Published in 2022 at "PLoS Neglected Tropical Diseases"
DOI: 10.1371/journal.pntd.0010556
Abstract: Background: Scabies was added to the WHO NTD portfolio in 2017 and targets for the control of scabies were included in the 2021-2030 WHO NTD roadmap. A major component of scabies control efforts a strategy… read more here.
Keywords: product profiles; control scabies; control; group ... See more keywords
Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions
Sign Up to like & getrecommendations! Published in 2022 at "PLoS Neglected Tropical Diseases"
DOI: 10.1371/journal.pntd.0010682
Abstract: In June 2021, the World Health Organization (WHO), recognizing the need for new diagnostics to support the control and elimination of onchocerciasis, published the target product profiles (TPPs) of new tests that would support the… read more here.
Keywords: product profiles; mass drug; onchocerciasis; support ... See more keywords
Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance
Sign Up to like & getrecommendations! Published in 2020 at "PLoS ONE"
DOI: 10.1371/journal.pone.0228311
Abstract: The essential role of rapid diagnostic tests (RDTs) in disease control is compromised every time a test is not performed correctly or its result is not reported accurately and promptly. A mobile app that utilizes… read more here.
Keywords: product profile; rapid diagnostic; app; target product ... See more keywords
WHO target product profiles to shape global research and development
Sign Up to like & getrecommendations! Published in 2023 at "Bulletin of the World Health Organization"
DOI: 10.2471/blt.22.289521
Abstract: Abstract Research and development leading to new and improved health products is essential for achieving healthier lives for populations worldwide. However, new products in development do not always match the global need for products for… read more here.
Keywords: target product; health; product; research development ... See more keywords
Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Pharmacology"
DOI: 10.3389/fphar.2022.948161
Abstract: Background: The target product profile (TPP) outlines the desired profile of a target product aimed at a particular disease and is used by companies to plan clinical development. Considering the increasing importance of health technology… read more here.
Keywords: target product; development; tpp; hta ... See more keywords