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Introduction to the proposals from the global bioanalysis consortium harmonization team.
Timmerman P, Arnold M, DeSilva B, Garofolo F, Golob M, van Amsterdam P, Kudoh S, Singhal P, Tang D, Riccio MF, Barrientos R, Savale S, Kurokawa T. Timmerman P, et al. Among authors: garofolo f. AAPS J. 2014 Nov;16(6):1159-61. doi: 10.1208/s12248-014-9609-4. Epub 2014 Oct 2. AAPS J. 2014. PMID: 25274604 Free PMC article. No abstract available.
International harmonization of bioanalytical guidance.
Bansal SK, Arnold M, Garofolo F. Bansal SK, et al. Among authors: garofolo f. Bioanalysis. 2010 Apr;2(4):685-7. doi: 10.4155/bio.10.39. Bioanalysis. 2010. PMID: 21083262 No abstract available.
2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Savoie N, Garofolo F, van Amsterdam P, Bansal S, Beaver C, Bedford P, Booth BP, Evans C, Jemal M, Lefebvre M, Lopes de Silva AL, Lowes S, Marini JC, Massé R, Mawer L, Ormsby E, Rocci ML Jr, Viswanathan C, Wakelin-Smith J, Welink J, White JT, Woolf E. Savoie N, et al. Among authors: garofolo f. Bioanalysis. 2010 Dec;2(12):1945-60. doi: 10.4155/bio.10.164. Bioanalysis. 2010. PMID: 21110739
2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
Garofolo F, Rocci ML Jr, Dumont I, Martinez S, Lowes S, Woolf E, van Amsterdam P, Bansal S, Barra AC, Bauer R, Booth BP, Carrasco-Triguero M, DeSilva B, Dunn J, Gallicano K, Gouty D, Ho S, Hucker R, Jemal M, Katori N, Le Blaye O, Lee J, Li W, Michael S, Nehls C, Nicholson R, Ormsby E, Tang D, Viswanathan CT, Weiner R, Young G. Garofolo F, et al. Bioanalysis. 2011 Sep;3(18):2081-96. doi: 10.4155/bio.11.192. Bioanalysis. 2011. PMID: 21942519
2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
DeSilva B, Garofolo F, Rocci M, Martinez S, Dumont I, Landry F, Dicaire C, Szekely-Klepser G, Weiner R, Arnold M, Bansal S, Bateman K, Bauer R, Booth B, Davis S, Dudal S, Gouty D, Grundy J, Haidar S, Hayes R, Jemal M, Kaur S, Kelley M, Knutsson M, Le Blaye O, Lee J, Lowes S, Ma M, Mitsuoka T, Neto JT, Nicholson R, Ormsby E, Sailstad J, Stevenson L, Tang D, Welink J, Viswanathan CT, Wang L, Woolf E, Yang E. DeSilva B, et al. Among authors: garofolo f. Bioanalysis. 2012 Sep;4(18):2213-26. doi: 10.4155/bio.12.205. Bioanalysis. 2012. PMID: 23046264
108 results