Abstract B22: IT-141, a stabilized polymer micelle formulation, prolongs the pharmacodynamic effect of SN-38

Author(s):  
Jyothi Sethuraman ◽  
Tara Lee Costich ◽  
Adam Carie ◽  
Taylor Buley ◽  
Tyler Ellis ◽  
...  
2021 ◽  
Author(s):  
Adam J. Schwarz

AbstractImaging biomarkers play a wide-ranging role in clinical trials for neurological disorders. This includes selecting the appropriate trial participants, establishing target engagement and mechanism-related pharmacodynamic effect, monitoring safety, and providing evidence of disease modification. In the early stages of clinical drug development, evidence of target engagement and/or downstream pharmacodynamic effect—especially with a clear relationship to dose—can provide confidence that the therapeutic candidate should be advanced to larger and more expensive trials, and can inform the selection of the dose(s) to be further tested, i.e., to “de-risk” the drug development program. In these later-phase trials, evidence that the therapeutic candidate is altering disease-related biomarkers can provide important evidence that the clinical benefit of the compound (if observed) is grounded in meaningful biological changes. The interpretation of disease-related imaging markers, and comparability across different trials and imaging tools, is greatly improved when standardized outcome measures are defined. This standardization should not impinge on scientific advances in the imaging tools per se but provides a common language in which the results generated by these tools are expressed. PET markers of pathological protein aggregates and structural imaging of brain atrophy are common disease-related elements across many neurological disorders. However, PET tracers for pathologies beyond amyloid β and tau are needed, and the interpretability of structural imaging can be enhanced by some simple considerations to guard against the possible confound of pseudo-atrophy. Learnings from much-studied conditions such as Alzheimer’s disease and multiple sclerosis will be beneficial as the field embraces rarer diseases.


1993 ◽  
Vol 22 (2) ◽  
pp. 85-92 ◽  
Author(s):  
Josephine C. Brackman ◽  
Jan B. F. N. Engberts

2008 ◽  
Vol 22 (2) ◽  
pp. 149-158 ◽  
Author(s):  
Sascha Kreuer ◽  
Jörgen Bruhn ◽  
Richard Ellerkmann ◽  
Stephan Ziegeler ◽  
Darius Kubulus ◽  
...  

RSC Advances ◽  
2020 ◽  
Vol 10 (31) ◽  
pp. 18305-18314
Author(s):  
Dan Liu ◽  
Zhuoling An ◽  
Pengfei Li ◽  
Yanhua Chen ◽  
Ruiping Zhang ◽  
...  

We developed a method that would provide novel insights for revealing the pharmacodynamic effect and mechanism of antipsychotic drugs (olanzapine).


2013 ◽  
Vol 1 (34) ◽  
pp. 4273 ◽  
Author(s):  
Jun Yue ◽  
Shi Liu ◽  
Zhigang Xie ◽  
Ying Xing ◽  
Xiabin Jing

Sign in / Sign up

Export Citation Format

Share Document