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Abstract:
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Innovation and conservative behavior are contradictory paradigms surrounding the development phase of the pharma industry, where regulated data processing and computing is a mission-critical aspect. Open-source software has the potential to provide both and neither. In the context of pharmaceutical development, the "free as in beer" aspect of open source is a quality that might seem attractive, though it is the "free as in speech" aspect where the actual benefit to the business can arise. We present issues that arise in the actual computer systems validation process and how they can be addressed. Both R, a general statistical programming language, and SPK, a tool for pharmacological modeling and simulation, will be used as case studies. We will conclude with possible strategies for incorporation and a sense of the cost/benefits that might arise.
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