Developing Treatment, Treatment Validation & Treatment Scope in the Setting of an Autism Clinical Trial
Abstract
We obtained IRB approval on December 7th ., 2009.. We applied for and received a COC from the NIH as required and received final approval from our IRB on March 25th 2010. The test material DHA and the placebo were acquired from Martek with a significant and unforeseen delay August 20th 2010 (please see Partnering project W81XWH-08-1-0730, Task #2). The Data Safety Monitoring Board and all other requirements for subject recruitment have been completed. Additional sources of subjects are being arranged to make up for delays occurring in obtaining IRB approval and issues obtaining the material from Martek (please see Partnering project W81XWH-08-1-0730, Tasks #1 and #2). We have established a set of LC-MSMS conditions appropriate for looking the presence of LXA4, RvD1, RvE1 and Maresin in urine. The necessary standards in natural and deuterated form have been prepared by total organic synthesis. We have established a set of LC-MSMS conditions appropriate for looking the presence of LXA4, RvD1, RvE1 and Maresin in urine. . Due to our late start we applied for and received a no-cost extension for this project. The SOW was updated on March 22nd 2010. and has been updated for the no-cost extension. Tasks remain the same only the timeframes in which they will be completed has changed. Please see initiating project W81XWH-08-1-0728 and partnering project W81XWH-08-1-0730
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2011
- Accession Number
- ADA556026
Entities
People
- T. P. Stein
Organizations
- University of Medicine and Dentistry of New Jersey