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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. Among authors: rocci ml jr. Bioanalysis. 2011 Sep;3(18):2081-96. doi: 10.4155/bio.11.192. Bioanalysis. 2011. PMID: 21942519 Free article.
Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.
Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L. Chen ML, et al. Among authors: rocci ml jr. Clin Ther. 2010 Sep;32(10):1704-12. doi: 10.1016/j.clinthera.2010.09.014. Clin Ther. 2010. PMID: 21194592
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: rocci ml jr. Bioanalysis. 2010 Dec;2(12):1945-60. doi: 10.4155/bio.10.164. Bioanalysis. 2010. PMID: 21110739 Free article.
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L. Chen ML, et al. Among authors: rocci ml jr. AAPS J. 2010 Sep;12(3):371-7. doi: 10.1208/s12248-010-9201-5. Epub 2010 May 4. AAPS J. 2010. PMID: 20440588 Free PMC article.
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L. Chen ML, et al. Among authors: rocci ml jr. Eur J Pharm Sci. 2010 May 12;40(2):148-53. doi: 10.1016/j.ejps.2010.03.017. Epub 2010 Mar 27. Eur J Pharm Sci. 2010. PMID: 20347972
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