GDUFA Research Outcomes

Nitrosamines

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to impurities such as nitrosamine drug substance related impurities (NDSRIs) that may arise in drug products, including generic products.

• All(33)
• Posters(0)
• Presentations(22)
• Papers(11)

• Genotoxicity Assessment of Eight Nitrosamines using 2D and 3D HepaRG Cell Models

  Seo, Ji-Eun; Yu, Joshua Z; Xu, Hannah; Li, Xilin; Atrakchi, Aisar; Mcgovern, Timothy; Bruno, KLD; Mei, Nan; Heflich, RH; Guo, Xiaoqing

• Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters

  Kulkarni, Chetan P; Yang, Jia; Koleske, Megan L; Lara, Giovanni; Khondoker, Alam; Raw, Andre; Rege, Bhagwant; Zhao, Liang; Lu, Dongmei; Zhang, Lei; Yu, Lawrence X; Lionberger, Robert; Giacomini, K M; Kroetz, DL; Yee, SW

• Lack of Effect of Antioxidants on Biopharmaceutics Classification System (BCS) Class III Drug Permeability

  Chiang Yu, Yuly; Lu, Dongmei; Rege, Bhagwant; Polli, James E

• Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure

  Zhang, Jinhui; Raghavachari, Ramesh; Kirkpatrick, Douglas; Keire, David A; Xu, Xiaoming; Faustino, Patrick J

• Optimizing the Detection of N-Nitrosamine Mutagenicity in the Ames Test

  Heflich, Robert; Bishop, Michelle; Mittelstaedt, Roberta; Yan, Jian; Guerrero, Sharon; Sims, Audrey; Mitchell, Kamela; Moore, Nyosha; Li, Xilin; Mei, Nan; Elespuru, Rosalie; King, Sruthi; Keire, David A; Kruhlak, Naomi; Dorsam, Robert; Raw, Andre; Davis Bruno, Karen; Mcgovern, Timothy; Atrakchi, Aisar

• Evaluating the Mutagenicity of N-Nitrosodimethylamine in 2D and 3D HepaRG Cell Cultures using Error-Corrected Next Generation Sequencing

  Seo, Ji-Eun; Le, Yuan; Revollo, Javier; Miranda-Colon, Jaime; Xu, Hannah; Mckinzie, Page; Mei, Nan; Chen, Tao; Heflich, RH; Zhou, Tong; Robinson, Timothy; Bonzo, Jessica; Guo, Xiaoqing

• Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances

  Lu, Dongmei; Rege, Bhagwant; Rawlings, Kimberly; Yang, Jingyue; Alam, Khondoker; Bode, C; Zhao, Liang; Faustino, Patrick; Wu, Fang; Shakleya, Diaa; Nickum, Elisa; Li, Bing; Wang, Rong; Stier, Ethan; Miezeiewski, Blair; Patel, Rachana; Boam, Ashley; Lionberger, Robert; Keire, D; Yu, Lawrence

• Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets

  Shakleya, Diaa; Asmelash, Bethel; Alayoubi, Alaadin; Abrigo, Nicholas; Mohammad, Adil; Wang, Jiang; Zhang, Jinhui; Yang, Jingyue; Marzan, Tim; Li, David; Shaklah, Maha; Alsharif, Fahd M; Desai, Saaniya; Faustino, Patrick J; Muhammad, Ashraf; O’connor, Thomas; Vera, Matthew; Raw, Andre; Sayeed, Vilayat; Keire, David

• Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study

  Yang, Jingyue; Kakarla, Raghavi; Marzan, Tim; Sherwin, Tim; George, Mark; Bennett, Justine; Basutto, Jose; Su, Yi; Ollerenshaw, Jason; Morin, Justin; Rebiere, Herve; Maggio, Annie Francoise; Kermaidic, Audrey; Gervela, Elodie; Breniew, Charlotte; Civade, Corinne; Chauvey, Denis; Duperray, Francoise; Wollein, Uwe; Conti, Massimiliano; Tromp, Jan; Meyer, Simon; Wanko, Richard; Wierer, Michael; Bertrand, Marie; Rodriguez, Jason; Sommers, Cynthia; Keire, David

• Revisiting the Mutagenicity and Genotoxicity of N-nitroso Propranolol in Bacterial and Human in Vitro Assays

  Li, Xilin; Le, Yuan; Seo, Ji Eun; Guo, Xiaoqing; Li, Yuxi; Chen, Si; Mittelstaedt, Roberta; Moore, Nyosha; Guerrero, Sharon; Sims, Audrey; King, Sruthi; Atrakchi, Aisar; Mcgovern, Timothy; Davis Bruno, Karen; Keire, David; Elespuru, Rosalie; Heflich, Robert; Mei, Nan