Escaping the cohort of concern: in vitro experimental evidence supports non-mutagenicity of N-nitroso-hydrochlorothiazide.

Autor: Gandhi, R. D., Hickert, S., Hoevelmann, Y., Mee, C. D., Schlingemann, J., Adams, A., Blanazs, A., Simon, S., Elloway, J., Rigger, L., Teasdale, A., Beaumont, C. V., Wright, L., Doherty, A.

Publikováno v: Archives of Toxicology; Dec2024, Vol. 98 Issue 12, p4159-4172, 14p

Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of stoichiometric DNA damage.

Autor: Fine J; Merck & Co., Inc., Rahway, NJ, USA., Allain L; Merck & Co., Inc., Rahway, NJ, USA., Schlingemann J; Merck KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany. Electronic address: joerg.schlingemann@merckgroup.com., Ponting DJ; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, UK., Thomas R; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, UK., Johnson GE; Institute of Life Science, Swansea University Medical School, Swansea, UK.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Dec; Vol. 145, pp. 105505. Date of Electronic Publication: 2023 Oct 05.

A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products.

Autor: Boetzel R; Pfizer R&D UK Limited, Sandwich CT13 9NJ, UK. Electronic address: ruth.boetzel@pfizer.com., Schlingemann J; Merck KGaA, Frankfurter Str. 250, Darmstadt 64293, Germany., Hickert S; Merck KGaA, Frankfurter Str. 250, Darmstadt 64293, Germany., Korn C; Sanofi-Aventis Deutschland GmsbH, Industriepark Höchst, 65926 Frankfurt am Main, Germany., Kocks G; Lhasa Limited, Leeds LS11 5PS, UK., Luck B; Takeda Pharma Austria, Industriestraße 67, 1220 Vienna, Austria., Blom G; Chemical Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield, UK., Harrison M; Chemical Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield, UK., François M; Technologie Servier, Center of Pharmaceutical Development, 45000 Orléans, France., Allain L; Analytical R&D, Merck & Co., Inc., Rahway, NJ 07065, USA., Wu Y; Drug Product Development, Bristol-Myers Squibb Company, New Brunswick, NJ 08901, USA., Bousraf Y; Technologie Servier, Center of Pharmaceutical Development, 45000 Orléans, France.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2023 Jun; Vol. 112 (6), pp. 1615-1624. Date of Electronic Publication: 2022 Apr 29.

The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals.

Autor: Schlingemann J; Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany. Electronic address: joerg.schlingemann@merckgroup.com., Burns MJ; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, United Kingdom., Ponting DJ; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, United Kingdom., Martins Avila C; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, United Kingdom; Current affiliation: Sai Life Sciences Limited, Basement A, Block 33, Alderley Park, Macclesfield, United Kingdom., Romero NE; U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD, USA., Jaywant MA; U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD, USA., Smith GF; AstraZeneca, Data Science and AI, Clinical Pharmacology and Safety Sciences, R&D, Cambridge, United Kingdom., Ashworth IW; Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, United Kingdom., Simon S; Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany., Saal C; Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany., Wilk A; U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD, USA.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2023 May; Vol. 112 (5), pp. 1287-1304. Date of Electronic Publication: 2022 Nov 17.

Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation Heliyon. 2021; 77: e06179.

Autor: Schlingemann J; Merck KGaA, Frankfurter Str. 250, Darmstadt, 64293, Germany., Hickert S; Merck KGaA, Frankfurter Str. 250, Darmstadt, 64293, Germany., Blom G; Chemical Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, Macclesfield, UK., Kocks G; Lhasa Limited, Leeds, UK., Allain L; Analytical R&D, Merck & Co., Inc., Rahway, NJ, 07065, USA.

Publikováno v: Heliyon [Heliyon] 2022 Jun 14; Vol. 8 (6), pp. e09607. Date of Electronic Publication: 2022 Jun 14 (Print Publication: 2022).