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TABLE II Validation Required at Each Stage of the Product Development Cycle [Pg.212]

Pre-clinical (Prior to human studies) Specificity, linearity [Pg.212]

Initiation of phase 1 clinical studies Specificity, linearity, range, accuracy, precision, LOD, LOQ [Pg.212]

Boudreau SP, McElvain JS, Martin LD, Dowling T, Fields SM (2004) Method validation by phase of development an acceptable analytical practice. Pharm Technol 28, pp 54-66 Sixsmith DG (2001) Outsourcing resources third-party technology transfer. Pharm Tech, pp 58-62... [Pg.187]

See other pages where Validation by Phase of Development is mentioned: [Pg.211]