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Adaptation of the WHO guideline for residual DNA in parenteral vaccines produced on continuous cell lines to a limit for oral vaccines.
Lebron JA, Troilol PJ, Pacchione S, Griffiths TG, Harper LB, Mixson LA, Jackson BE, Michna L, Barnum AB, Denisova L, Johnson CN, Maurer KL, Morgan-Hoffman S, Niu Z, Roden DF, Wang Z, Wolf JJ, Hamilton TR, Laux KM, Soper KA, Ledwith BJ. Lebron JA, et al. Among authors: soper ka. Dev Biol (Basel). 2006;123:35-44; discussion 55-73. Dev Biol (Basel). 2006. PMID: 16566435
P53+/- hemizygous knockout mouse: overview of available data.
Storer RD, French JE, Haseman J, Hajian G, LeGrand EK, Long GG, Mixson LA, Ochoa R, Sagartz JE, Soper KA. Storer RD, et al. Among authors: soper ka. Toxicol Pathol. 2001;29 Suppl:30-50. doi: 10.1080/019262301753178465. Toxicol Pathol. 2001. PMID: 11695560 Review.
Antigen levels and antibody titers after DNA vaccination.
Chastain M, Simon AJ, Soper KA, Holder DJ, Montgomery DL, Sagar SL, Casimiro DR, Middaugh CR. Chastain M, et al. Among authors: soper ka. J Pharm Sci. 2001 Apr;90(4):474-84. doi: 10.1002/1520-6017(200104)90:4<474::aid-jps1005>3.0.co;2-6. J Pharm Sci. 2001. PMID: 11170037
An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.
Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, Storer RD, Reddy MV, Kraynak A, Trela B, Bienvenu JG, Bjurström S, Bosmans V, Brewster D, Colman K, Dominick M, Evans J, Hailey JR, Kinter L, Liu M, Mahrt C, Marien D, Myer J, Perry R, Potenta D, Roth A, Sherratt P, Singer T, Slim R, Soper K, Fransson-Steen R, Stoltz J, Turner O, Turnquist S, van Heerden M, Woicke J, DeGeorge JJ. Sistare FD, et al. Toxicol Pathol. 2011 Jun;39(4):716-44. doi: 10.1177/0192623311406935. Toxicol Pathol. 2011. PMID: 21666103
56 results