Development of Dosage Forms & Delivery Systems for Antitumor Agents

将评价所有候选化合物的静脉注射适用性。一些化合物本身表现出足够的药物性质。然而，许多其他的存在显著的溶解度和稳定性问题，其不适合于溶剂方法或pH调节。根据项目需求（化合物的潜力）和项目官员的判断，这些化合物可能需要进行长期研究。研究了新化学实体并阐明了其物理化学特征。可能有必要进行研究，以获得适用于动物“概念验证”研究并最终适用于人体临床试验的非传统（替代）剂型。要求承包商提供书面的最终项目报告，其中包括扩大生产的建议。在某些情况下，承包商提供中试规模批次的成品剂型，用于疗效模型评价。

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.