A review of the currently available technologies, as well as recommendations for the evaluation of new, is provided. A comprehensive review of the design, procurement and proper use of various types of control materials, including blood samples, residual patient samples, products of whole genome amplification, synthetic oligonucleotide simplex and multiplex controls, and plasmids is provided. Current assay formats can be used to ensure proper verification and validation protocols and corresponding data analysis and result reporting for multiplex assays described illustrate.
RhITF is an oral spray in development for the prevention of chemotherapy-induced oral mucositis. The phase II trial was conducted at the poster presentation titled, featured Recombinant human intestinal trefoil factor oral spray for prophylaxis of chemotherapy-induced oral mucositis. The presented data show that in addition to meeting the primary World Health Organization scale endpoint, the study also met its secondary endpoint OMAS score. The OMAS and WHO score systems complement, OMAS is to enable a new, objective, validated quantification tool doctors mucosal tissue to quantify the damages and a multidisciplinary team a multidisciplinary team to assess the benefits of new drugs for oral mucositis in clinical trials (Sonis.. Michael A. Zoccoli, General Manager, IVD Business, Celera, and Co – Chair of the CLSI committee , the sections onoped MM17 MM17 – as as ‘the best information available in this field at the present time for laboratories in developing and offering these complex assays interest for diagnostic purposes., the sections on reference materials and data analysis will be particularly useful for the laboratory percent this releaseand quality control materials, – analytical verification and validation; – Data Analysis and – reporting of results.
The GI Company Reports Additional Phase II clinical data of Intestinal Trefoil Factor oral spray for oral mucositis/ At the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology 2008 International Symposium on Supportive Care in Cancer last week in Houston, reported the businesses GI secondary endpoints relating to oral Mucositis assessment Scale scores from the Company’s phase II clinical trial to assess the safety and efficacy of its lead clinical compound, Intestinal Trefoil Factor evaluate Oral Spray, in the development for oral mucositis. Continue reading