Developing Treatment, Treatment Validation, and 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 LCMSMS conditions appropriate for looking the presence of LXA4, RvD1, RvE1 and Maresin in urine. The SOW was updated on March 22nd 2010.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2010
- Accession Number
- ADA540353
Entities
People
- Peter Stein
Organizations
- Robert Wood Johnson Medical School