IGF::OT::IGF : Analytical Services Center for Medications Development Program. September 15, 2013 - September 14, 2018. N01DA-13-8920.PURPOSE: To obligate funds to fully fund performance under T

承包商应使用有效的分析方法对从临床前和临床研究中收集的生物样本中的各种化合物进行定性和/或定量分析。生物标本包括但不限于血浆/血清、尿液、唾液、头发和组织。分析包括但不限于新药和/或其代谢物、滥用药物/代谢物、潜在伴随药物/化合物、替代结果指标和/或分子生物标记物(小分子、多肽、蛋白质、酶等)。承包商还应开发和验证未建立既定检测方法的药物/化合物的新检测方法。

The Contractor shall carry out qualitative and/or quantitative assays for a variety of compounds in biological specimens collected from preclinical and clinical studies using validated analytical methods. The biological specimens include, but are not limited to, plasma/serum, urine, saliva, hair and tissues. The analytes include, but are not limited to, new medications and/or their metabolites, abused drugs/metabolites, potential concomitant medications/compounds, and surrogate outcome measures and/molecular biomarkers (small molecules, peptides, proteins, enzymes, etc). The Contractor shall also develop and validate new assay methods for medications/compounds for which established assays do not exist.