RESEARCH PHARMACY

研究药房

• 批准号: 8602871
• 负责人: MARK G KLANG
• 金额: $ 20.39万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-20 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8602871
• 关键词: Antibodies; Biological Assay; Cancer Center Support Grant; Clinical; Clinical Trials; Cyclic GMP; Development; Devices; Drug Formulations; Equipment; Evaluation; Excipients; FDA approved; Fluorescence; Growth; High Pressure Liquid Chromatography; Injectable; Injection of therapeutic agent; Investigational Drugs; Life; Memorial Sloan-Kettering Cancer Center; Oral; Pharmaceutical Preparations; Pharmacy facility; Preparation; Process; Research; Services; Sterility; Ultraviolet Rays; Vaccines; Validation; Visible Radiation; capsule; clinical practice; detector; improved; microbial; placebo controlled study; small molecule

The Research Pharmacy provides a mechanism to develop, procure and validate the preparation and packaging of investigational drugs for clinical use. Aims include: - Development and validation of stability indicating assays - Verifying the accuracy of compounded medications - Determine the extended stability to improve medication shelf life - Validated packaging of medications where MSKCC holds the IND. Services include, but are not limited to, formulation analysis, selection of excipients, evaluation of release rates, prediction of interactions and determination of compatibility and stability of medications used in clinical practice. Specific equipment is available to package medications in capsules which is ideal for placebo controlled trials, as well as a Class 10,000 cleanroom for aseptic packaging of sterile injectables (vaccines, antibodies, small molecule injectables and opthalmics). The cleanroom is also helpful in reducing contamination in packaging of oral products which are prone to microbial growth - such as sugarbased formulations. This facility approaches cGMP standards and is fully compliant with the stipulations of USP 29 specifically chapters 795, 797, 1163 and 1075. All processes are thoroughly validated in accordance with all compendial standards. This facility also makes ample use of High Performance Liquid chromatography (HPLC) and is equipped with a Photodiode array for both UV and visible light and a fluorescence detector. This device has been used to validate the accuracy of all medications compounded within the facility. The fluorescence detector is useful to tract minute elutions from depot injection. The HPLC device has been used to determine extended stability of FDA approved drugs in clinical use here at MSKCC.

研究药房提供了一种开发、采购和验证制剂的机制， 临床使用的研究药物的包装。 目标包括： - 稳定性指示试验的开发和验证 - 保证复合药物的准确性 - 确定延长稳定性以延长药物有效期 - MSKCC持有IND的药物的经验证包装。 服务包括但不限于配方分析、辅料选择、释放度评估 使用的药物的相互作用的预测和相容性和稳定性的确定 临床实践专用设备可用于将药物包装在胶囊中， 安慰剂对照试验，以及用于无菌注射剂无菌包装的10，000级洁净室 （疫苗、抗体、小分子注射剂和眼科治疗剂）。洁净室也很有帮助， 减少易于微生物生长的口腔产品包装中的污染-例如糖基 制剂。该设施接近cGMP标准，完全符合 USP 29特别是第795、797、1163和1075章。所有工艺均经过全面验证， 符合所有药典标准。该设施还充分利用高性能液体 该仪器配备有用于UV和可见光的光电二极管阵列和用于UV和可见光的光电二极管阵列。 荧光检测器该设备已用于验证所有药物混合的准确性 在设施内。荧光检测器可用于追踪贮库注射液的微量洗脱液。的 HPLC装置已用于测定FDA批准的临床使用药物的延长稳定性， MSKCC。