Publications by authors named "Sarmistha Sanyal"
Evaluating the Use of KIM-1 in Drug Development and Research Following FDA Qualification.
Clin Pharmacol Ther
December 2018
Article Synopsis
- - The Biomarker Qualification Program was created by the FDA's CDER to speed up the use of promising biomarkers in drug development, starting with the qualification of seven safety biomarkers in 2008, including KIM-1 for detecting kidney damage in rats.
- - This article reviews the application of KIM-1 in drug development and research, examining data from various sources such as FDA databases, ClinicalTrials.gov, and PubMed.
- - Findings show that after KIM-1 was qualified, its use significantly increased in drug development programs analyzed by CDER and in subsequent research on kidney injury detection.
The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU).
View Article and Find Full Text PDFMyoblast fusion into multinucleated myotubes is a crucial step in skeletal muscle development and regeneration. Here, we accumulated murine myoblasts at the ready-to-fuse stage by blocking formation of early fusion intermediates with lysophosphatidylcholine. Lifting the block allowed us to explore a largely synchronized fusion.
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