favourable physicochemical characteristics, enabling formulations may not be necessary to achieve desired clinical outcomes. In this instance simple dosing strategies may be employed in the clinical without the need for extensive formulation development activities to support early clinical evaluation. • Short term clinical focus: Where the strategy of a company is to achieve limited early clinical data (such as safety/tolerability and dose escalation) prior to selling an asset or requiring such data to support further funding requirements, extensive formulation development may not be appropriate. In general, formulation development activities should be performed as early as possible in the drug development process to optimize the efficacy, safety, and stability of the drug product. However, in certain situations where companies need to reach end of Phase I milestones quickly for commercial reasons the strategy adopted for clinical dosing should be considered carefully to marry cost/time/risk against milestone aims.
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