Product development critical success factors

Cooper, R. G. and Kleinschmidt, E. J. 1995 Benchmarking the Finu s Critical Success Factors in New Product Development. Journal of Product Innovation Management, 12(5), 374-391. 

As pharmaceutical companies strive to increase productivity and decrease costs, they must improve their skills in dealing with CROs. This chapter examines the challenges of outsourcing clinical drug development activities and identifies critical success factors for working with CROs. 

Silva (2001) considers that for small and medium companies to be regarded as pioneers in product development, it is not a critical success factor. So, additional scrutiny is applied to the study of manufacture and assembly, the structured assessments of conditions and the productive resources, internally and externally available, as a means of reducing costs and optimizing deadlines for product launching. 

Amorphous solid dispersions can be successfully transformed into an appropriate solid form like a tablet or ahard gelatin capsuleby judiciously selecting the processing technologies. Critical process parameters must be identified and excipients carefully selected in order to obtain a final drug product with the desired quality attributes. Each of these factors plays a critical role in developing a successful commercial product from a solid amorphous dispersion. 

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