但是,我们所讨论的内部TPP并不是与食品和药物管理局(FDA)共享的TPP。术语“TPP”已被FDA采纳,主要指的是包装说明书(PI)大纲草案。(参见 fda.gov 上的指南草案,“Target Product Profile–A Strategic Development Tool”。) 该TPP本质...
Target product profile: A renaissance for its definition and use - Tebbey, Rink () Citation Context .../11 $58.00+.00 漏 2011 Bentham Science Publishers Ltd.1276 Current Topics in Medicinal Chemistry, 2011, Vol. 11, No. 10 Wyatt et al. The TPP is an important strategic planning and ...
Regardless of the drug development strategy used, or whether an oral or long-acting injectable formulation is developed, the revised TPP provides guidance to the desired attributes of the next-generation chemoprevention drugs (Table 1). Table 1 Target product profile for malaria chemoprevention Full...
DEVELOPMENT PLANGursharan SinghLife Sciences, SmartAnalyst India Private Limited, Gurgaon, Haryana, IndiaTARGET PRODUCT PROFILE5.1 INTRODUCTIONAs the name suggests, “Target Product Profile,” also known as the TPP, refers to the targeted orintended profile a pharmaceutical/biotechnology product or ...
We then further defined hits as those compounds that along with these in vitro hit criteria (⩾0.5 logs inhibition of Wolbachia 16S and ⩽30% cytotoxicity) are also available in an oral formulation in order to align our hit picking strategy to the Target Product Profile (TPP) criteria. ...
This review aims to provide a novel TPP for ICT and presents promising tried and untried combinatorial approaches that could be used to achieve the target product profile. We also highlight regulatory barriers to the development and adoption of ICT, particularly in the United States, where ICT ...
A SEC medicine would optimally be a combination of two compounds, with minimal acceptable profile of causal liver stage activity, plus potential benefit from activity against asexual blood stages, which need not be fast-onset. The definition of this TPP, TPP-2, was conceptually built around atova...
b Structures of some previously reported activity-based probes of natural medicines Another example is ferroptocide,76 a small molecule chemically derived from the diterpene natural product pleuromutilin that rapidly and robustly induces ferroptotic death of cancer cells. After biological evaluation, Lla...
In such a context, there is an urgent need for convenient, well-tolerated and efficacious alternative drugs addressing the limitations of current interventions and meeting the needs of a broader target population. A revised target product profile (TPP) outlining both the minimal acceptable and ideal...
TPP: target product profile WHO: World Health Organization References WHO. World Malaria Report 2015. Geneva, World Health Organization, 2015.http://www.whoint/malaria/publications/world-malaria-report-2015/report/en/. 2015. malERA Consultative Group on Drugs. A research agenda for malaria eradicat...