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Microbial Risk in Pharmaceutical Manufacturing and ICH Q9.
Guilfoyle DE, Friedman RL, Hughes PF, Hussong D, Rosenberg AS, Brorson K. Guilfoyle DE, et al. PDA J Pharm Sci Technol. 2013 Mar-Apr;67(2):79-80. doi: 10.5731/pdajpst.2013.00915. PDA J Pharm Sci Technol. 2013. PMID: 23569069 No abstract available.
Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
Zamiri C, Leiske DL, Hughes PF, Kirwan JP, Der E, Cox E, Warburton R, Goss M, Weiser S, Perez-Brown J, Gopalrathnam G, Liu J, Mehta SB, Shereefa S, Specht S, Aedo SJ, Goldbach P, Jia F, Kuehnle B, Page S, Voeten L, Yi L, Zhu C. Zamiri C, et al. Among authors: hughes pf. PDA J Pharm Sci Technol. 2023 Oct 17:pdajpst.2022.012806. doi: 10.5731/pdajpst.2022.012806. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37848203
FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.
Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P. Amiri-Kordestani L, et al. Among authors: hughes p. Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30. Clin Cancer Res. 2014. PMID: 24879797 Clinical Trial.
Genetic Causes and Genomic Consequences of Breakdown of Distyly in Linum trigynum.
Gutiérrez-Valencia J, Zervakis PI, Postel Z, Fracassetti M, Losvik A, Mehrabi S, Bunikis I, Soler L, Hughes PW, Désamoré A, Laenen B, Abdelaziz M, Pettersson OV, Arroyo J, Slotte T. Gutiérrez-Valencia J, et al. Among authors: hughes pw. Mol Biol Evol. 2024 May 3;41(5):msae087. doi: 10.1093/molbev/msae087. Mol Biol Evol. 2024. PMID: 38709782 Free PMC article.
1,612 results