IGF::OT::IGF: ANALYTICAL CHEMISTRY AND STABILITY TESTING OF TREATMENT DRUGS FOR SUBSTANCE USE DISORDERS. N01DA-14-8918. PERIOD OF PERFORMANCE: AUGUST 4, 2014 TO AUGUST 3, 2015.

IGF::OT::IGF：药物使用障碍治疗药物的分析化学和稳定性测试。

• 批准号: 9119729
• 负责人: PETER SILINSKI
• 金额: $ 54.31万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-04 至 2016-08-03
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9119729
• 关键词: Analytical Chemistry; Databases; Detection; Documentation; Dosage Forms; Drug Formulations; Ensure; Equipment and supply inventories; Excipients; Government; Guidelines; International; Methods; National Institute of Drug Abuse; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Quality Control; Recovery; Research Personnel; Sampling; Secure; Site; Specificity; Stress Tests; Substance Use Disorder; Testing; analytical method; drug testing; improved; potency testing; stability testing; symposium

Develop or improve test methods for drug substances and drug products provided by the Government to ensure the purity, identify and strength, and to characterize them physically and chemically and to validate analytical methods developed for drug substances and finished dosage forms to include documentation, as needed, of method specificity, linearity, accuracy, precision, detection limit, quantitation limit, recovery, ruggedness, and sample stability in a format acceptable to the FDA.

开发或改进政府提供的原料药和药品的检测方法，以确保纯度、鉴定和强度，并对其进行物理和化学表征，并验证原料药和成品剂型开发的分析方法，以FDA可接受的格式，根据需要包括方法特异性、线性、准确性、精密度、检出限、定量限、回收率、坚固性和样品稳定性的文件。