The estimation and use of measurement uncertainty for a drug substance test procedure validated according to USP <1225>

Author:

Weitzel M. L. Jane

Publisher

Springer Science and Business Media LLC

Subject

Safety, Risk, Reliability and Quality,Instrumentation,General Chemical Engineering,General Chemistry

Reference8 articles.

1. Hauck WW, Koch W, Abernethy D, Williams RL, USP (2008) Making sense of trueness, precision, accuracy, and uncertainty. USP Pharm Forum 34(3):838

2. Byrialsen K, Soerensen EM, Riber UM, Redder T, Jespersen AM, Zeuthen N (2008) Novo Nordisk A/S, Krogshøjvej 51, KD-2880 Bagsværd, Denmark. Uncertainty statement regarding USP reference standards. USP Pharm Forum 34(2):477

3. Small Molecules Collaborative Group, Williams RL, Abernethy DR, Koch WF, Hauck WW, Cecil TL (2009) Performance-based monographs. USP Pharm Forum 35(3) May-June 2009

4. Pappa HN (2011) General chapter <1225> validation of compendial methods. USP34-NF29, p 778

5. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use (2005) Validation of analytical procedures: text and methodology Q2(R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf

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