Evolution of the CANDA at Roche.
Computer-assisted NDAs (CANDAs) have evolved from an instrument that provides information to regulators to also providing information to internal researchers. They are still not as useful internally during the NDA process as they will be in the future. The portion of CANDA that allows summary, display, and query of the raw data is the most complicated part of the CANDA. Roche's current CANDA system, as well as the challenges in using, documenting, and validating such a system, is described, stressing the features that make it usable in-house. Roche's vision of the future is outlined, covering the strategies, targets, and expected savings.
Rutman
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Hoffmann-La Roche Inc., Nutley, New Jersey 07110, USA.
Givens
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D003628:Database Management Systems; D016208:Databases, Factual; D017277:Drug Approval; D016903:Drug Monitoring; D017387:Investigational New Drug Application