Development of Dosage Forms & Delivery Systems for Antitumor Agents

将对所有候选化合物进行静脉注射适宜性评估。有些化合物本身就表现出足够的药用性能。然而，许多其他的存在着严重的溶解性和稳定性问题，不适用于溶剂法或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。对新的化学实体进行了研究，并阐明了其物理化学性质。可能有必要进行研究，使非传统(替代)剂型适合在动物身上进行“概念验证”研究，并最终在人类临床试验中使用。承包商必须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，承包商提供成品剂型的中试批次，以便在疗效模型中进行评估。

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.