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.
