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Foreign particles testing in orally inhaled and nasal drug products.
Blanchard J, Coleman J, Hayling CD, Ghaderi R, Haeberlin B, Hart J, Jensen S, Malcolmson R, Mittelman S, Nagao LM, Sekulic S, Snodgrass-Pilla C, Sundahl M, Thompson G, Wolff R; International Pharmaceutical Aerosol Consortium on Regulation; Science Foreign Particles Working Group. Blanchard J, et al. Among authors: nagao lm. Pharm Res. 2004 Dec;21(12):2137-47. doi: 10.1007/s11095-004-7665-7. Pharm Res. 2004. PMID: 15648243 Review.
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.
Parris P, Martin EA, Stanard B, Glowienke S, Dolan DG, Li K, Binazon O, Giddings A, Whelan G, Masuda-Herrera M, Bercu J, Broschard T, Bruen U, Callis CM, Stults CLM, Erexson GL, Cruz MT, Nagao LM. Parris P, et al. Among authors: nagao lm. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429
13 results