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
Anomeric Selectivity and Product Profile of a Processive Cellulase.
Sign Up to like & getrecommendations! Published in 2017 at "Biochemistry"
DOI: 10.1021/acs.biochem.6b00636
Abstract: Cellobiohydrolases (CBHs) make up an important group of enzymes for both natural carbon cycling and industrial deconstruction of lignocellulosic biomass. The consecutive hydrolysis of one cellulose strand relies on an intricate pattern of enzyme-substrate interactions… read more here.
Keywords: profile processive; product; product profile; selectivity product ... 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
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
Target product profile for readers of rapid diagnostic tests
Sign Up to like & getrecommendations! Published in 2023 at "Bulletin of the World Health Organization"
DOI: 10.2471/blt.23.289728
Abstract: Abstract While equipment-free visual interpretation is a benefit of lateral-flow assays, automating the reading of rapid diagnostic tests promotes proper test performance, interpretation and reporting of the results. We have created a target product profile… read more here.
Keywords: rapid diagnostic; health; test; product profile ... See more keywords