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Page 1
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids.
Jolly RA, Bandara S, Bercu J, Callis CM, Dolan DG, Graham J, HaMai D, Barle EL, Maier A, Masuda-Herrera M, Moudgal C, Parker JA, Reichard J, Sandhu R, Fung ES. Jolly RA, et al. Among authors: barle el. Regul Toxicol Pharmacol. 2022 Oct;134:105242. doi: 10.1016/j.yrtph.2022.105242. Epub 2022 Aug 11. Regul Toxicol Pharmacol. 2022. PMID: 35964842
A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.
Hayes EP, Jolly RA, Faria EC, Barle EL, Bercu JP, Molnar LR, Naumann BD, Olson MJ, Pecquet AM, Sandhu R, Shipp BK, Sussman RG, Weideman PA. Hayes EP, et al. Among authors: barle el. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S39-47. doi: 10.1016/j.yrtph.2016.06.001. Epub 2016 Jun 3. Regul Toxicol Pharmacol. 2016. PMID: 27267172 Review.
Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning.
Olson MJ, Faria EC, Hayes EP, Jolly RA, Barle EL, Molnar LR, Naumann BD, Pecquet AM, Shipp BK, Sussman RG, Weideman PA. Olson MJ, et al. Among authors: barle el. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S19-27. doi: 10.1016/j.yrtph.2016.05.024. Epub 2016 May 24. Regul Toxicol Pharmacol. 2016. PMID: 27233923 Review.
Cancer risk of immunosuppressants in manufacturing.
Barle EL, Winkler GC, Ulrich P, Perino C, Kuster M, Probst A, Thielen S, Bechter R. Barle EL, et al. Regul Toxicol Pharmacol. 2014 Oct;70(1):122-4. doi: 10.1016/j.yrtph.2014.06.025. Epub 2014 Jul 2. Regul Toxicol Pharmacol. 2014. PMID: 24997232
11 results