Joel P Bercu
Overview
Explore the profile of Joel P Bercu including associated specialties, affiliations and a list of published articles.
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Articles
25
Citations
67
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Recent Articles
1.
Kostal J, Voutchkova-Kostal A, Bercu J, Graham J, Hillegass J, Masuda-Herrera M, et al.
Chem Res Toxicol
. 2024 Jul;
37(8):1404-1414.
PMID: 39069667
Skin sensitization is a critical end point in occupational toxicology that necessitates the use of fast, accurate, and affordable models to aid in establishing handling guidance for worker protection. While...
2.
Johnson C, Kiehl D, Christiaens P, Jodar F, Cuyvers R, Bassan A, et al.
PDA J Pharm Sci Technol
. 2024 Jun;
78(3):214-236.
PMID: 38942477
Leachables in pharmaceutical products may react with biomolecule active pharmaceutical ingredients (APIs), for example, monoclonal antibodies (mAb), peptides, and ribonucleic acids (RNA), potentially compromising product safety and efficacy or impacting...
3.
Bercu J, Ponting D, Ripp S, Dobo K, Totah R, Bolleddula J
Clin Pharmacol Ther
. 2024 Mar;
116(1):34-37.
PMID: 38494918
No abstract available.
4.
Bercu J, Zhang S, Sobol Z, Escobar P, Van P, Schuler M
Mutat Res Genet Toxicol Environ Mutagen
. 2023 Sep;
891:503685.
PMID: 37770142
N-Nitrosodiethylamine (NDEA), a well-studied N-nitrosamine, was tested in rats to compare the dose-response relationship of three genotoxicity endpoints. Mutant / mutation frequencies were determined using the transgenic rodent (TGR) gene...
5.
Bercu J, Masuda-Herrera M, Trejo-Martin A, Sura P, Jolly R, Kenyon M, et al.
Regul Toxicol Pharmacol
. 2023 May;
142:105415.
PMID: 37257751
Low levels of N-nitrosamines (NAs) were detected in pharmaceuticals and, as a result, health authorities (HAs) have published acceptable intakes (AIs) in pharmaceuticals to limit potential carcinogenic risk. The rationales...
6.
Trejo-Martin A, Bercu J, Thresher A, Tennant R, Thomas R, Cross K, et al.
Regul Toxicol Pharmacol
. 2022 Aug;
135:105247.
PMID: 35998738
Under ICH M7, impurities are assessed using the bacterial reverse mutation assay (i.e., Ames test) when predicted positive using in silico methodologies followed by expert review. N-Nitrosamines (NAs) have been...
7.
Masuda-Herrera M, Bercu J, Broschard T, Burild A, Hasselgren C, Parris P, et al.
PDA J Pharm Sci Technol
. 2022 Jan;
76(5):369-383.
PMID: 35031541
The threshold of toxicological concern (TTC), i.e., the dose of a compound lacking sufficient experimental toxicity data that is unlikely to result in an adverse health effect in humans, is...
8.
Bercu J, Masuda-Herrera M, Johnson G, Czich A, Glowienke S, Kenyon M, et al.
Regul Toxicol Pharmacol
. 2021 Apr;
123:104926.
PMID: 33862169
The ICH M7(R1) guideline describes a framework to assess the carcinogenic risk of mutagenic and carcinogenic pharmaceutical impurities following less-than-lifetime (LTL) exposures. This LTL framework is important as many pharmaceuticals...
9.
Mitra M, Datta K, Hutchinson R, Nicolette J, Pettersen J, Wegesser T, et al.
Regul Toxicol Pharmacol
. 2021 Feb;
122:104895.
PMID: 33610610
As per the ICH Q3A(R2) and Q3B(R2) regulatory guidelines, safety studies may be needed when an impurity in new drug substances or products is above the qualification threshold, and such...
10.
Drewe W, Dobo K, Sobol Z, Bercu J, Parris P, Nicolette J
Int J Toxicol
. 2021 Feb;
40(3):285-298.
PMID: 33525949
A workshop entitled "Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis" was held at the 2018 Genetic Toxicology Association annual meeting. The objectives of the workshop were to...