Development of Dosage Forms & Delivery Systems for Antitumor Agents

剂型的开发

• 批准号: 7693616
• 金额: $ 29.01万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7693616
• 关键词: Development; Dosage; Forms; Delivery; Systems

Suitability for intravenous injection will be evaluated for all candidate compounds. Some compounds exhibit adequate pharmaceutical properties per se. However, many others present significant solubility and stability problems that are not amenable to solvent approaches or pH adjustment. These compounds may require long range studies depending on program needs (potential of the compound) and judgment of the Project Officer. The new chemical entity is studied and its physicochemical characteristics elucidated. It may be necessary to conduct studies leading to non-traditional (alternate) dosage forms suitable for 'proof of concept' studies in animals and ultimately in human clinical trials. The Contractor is required to provide written final project reports which include recommendations for scale-up manufacturing. In some cases, the contractor provides pilot-scale batches of finished dosage forms for evaluation in efficacy models.

将评估所有候选化合物的静脉注射的适用性。一些化合物本身具有足够的药物特性。但是，许多其他人提出了明显的溶解度和稳定性问题，这些问题不适合溶剂方法或pH调节。这些化合物可能需要根据计划需求（潜在的化合物）和项目官员的判断而需要远程研究。研究了新的化学实体，并阐明了其理化特征。可能有必要进行研究，从而导致适用于动物的“概念证明”研究的非传统（替代）剂型，并最终在人类临床试验中进行。承包商必须提供书面最终项目报告，其中包括用于扩大制造的建议。在某些情况下，承包商提供了成品剂型的试验尺度批次，以在功效模型中进行评估。