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Risk analysis by FMEA as an element of analytical validation.
van Leeuwen JF, Nauta MJ, de Kaste D, Odekerken-Rombouts YM, Oldenhof MT, Vredenbregt MJ, Barends DM. van Leeuwen JF, et al. Among authors: barends dm. J Pharm Biomed Anal. 2009 Dec 5;50(5):1085-7. doi: 10.1016/j.jpba.2009.06.049. Epub 2009 Jul 7. J Pharm Biomed Anal. 2009. PMID: 19640668
Consistency of FMEA used in the validation of analytical procedures.
Oldenhof MT, van Leeuwen JF, Nauta MJ, de Kaste D, Odekerken-Rombouts YM, Vredenbregt MJ, Weda M, Barends DM. Oldenhof MT, et al. Among authors: barends dm. J Pharm Biomed Anal. 2011 Feb 20;54(3):592-5. doi: 10.1016/j.jpba.2010.09.024. Epub 2010 Oct 20. J Pharm Biomed Anal. 2011. PMID: 20970277
Choice and validation of a near infrared spectroscopic application for the identity control of starting materials. practical experience with the EU draft Note for Guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization.
Vredenbregt MJ, Caspers PW, Hoogerbrugge R, Barends DM. Vredenbregt MJ, et al. Among authors: barends dm. Eur J Pharm Biopharm. 2003 Nov;56(3):489-99. doi: 10.1016/s0939-6411(03)00119-x. Eur J Pharm Biopharm. 2003. PMID: 14602194
63 results