RESEARCH PHARMACY

研究药房

• 批准号: 8375204
• 负责人: MARK G KLANG
• 金额: $ 9.26万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8375204
• 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、采购和验证制剂和药物的机制。 临床使用的研究药物的包装。 目标包括： - 稳定性指示分析的开发和验证 - 验证复合药物的准确性 - 确定延长稳定性以延长药物保质期 - MSKCC 持有 IND 的药物包装经过验证。 服务包括但不限于配方分析、辅料选择、释放评估 率、相互作用的预测以及所用药物的相容性和稳定性的确定 临床实践。有专门的设备可将药物包装在胶囊中，这非常适合 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药物）。洁净室也有帮助 减少易于微生物生长的口腔产品（例如糖基产品）包装中的污染 配方。该设施接近cGMP标准，完全符合cGMP的规定 USP 29 特别是第 795、797、1163 和 1075 章。所有流程均经过彻底验证 符合所有药典标准。该设施还充分利用高性能液体 色谱法 (HPLC)，并配备了用于紫外光和可见光的光电二极管阵列以及 荧光检测器。该设备已用于验证所有药物配制的准确性 设施内。荧光检测器可用于追踪来自储库注射的微小洗脱物。这 HPLC 设备已用于确定 FDA 批准的药物在临床使用中的延长稳定性，网址为 MSKCC。