Drug Designing: Open Access
Open Access

Holen KD

Publications

• Research Article
  Exposure Adjusted Continuous Reassessment Method (EACRM) - an Adaptive Design Incorporating Time to Toxicity Event for Phase I Dose Finding Studies.
  Author(s): Qi X, Munasinghe W, Hosmane B, Chiu Y and Qi X, Munasinghe W, Hosmane B, Chiu Y and
  
  Finding the maximum tolerated dose (MTD) is the most important primary objective for Phase I oncology studies. The drug exposure and the toxicity event are the two components required for characterization of the MTD. Phase I trials currently require multiple subjects treated at numerous dose levels, with many of these subjects receiving doses of drug at less than predicted efficacious exposures. Further, these studies employ predefined, step-wise increments in doses that can result in inaccurate predictions of the MTD. Improvements to conventional adaptive dose finding designs to attain more accurate information on the extent of exposure and the time to event, with a more dynamic enrollment to facility better decision making are needed and have been the focus of previous published efforts. The EACRM dynamically extends the conventional adaptive dose finding designs by incorporating do.. View More»
  DOI: 10.4172/2169-0138.1000122

  Abstract PDF

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