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FDA Draft guidance Quality Metrics Data Guidance for Industry 2016.11
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Nuala Calnan, Kevin O’Donnell and Anne Greene Enabling ICH Q10 Implementation–Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9 PDA J Pharm Sci and Tech 2013, 67 581-600
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Ikujiro Nonaka. A Dynamic Theory of Organizational Knowledge Creation. Organization Science, Vol. 5, No.1 (Feb., 1994), pp. 14-37
