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 Evaluation of Nitrosamine Impurities using Human TK6 Cells Transduced with Cytochrome P450s

  Li, Xilin; He, Xiaobo; Le, Yuan; Guo, Xiaoqing; Bryant, Matthew; Atrakchi, Aisar; Mcgovern, Timothy; Davis Bruno, Karen; Keire, David; Heflich, Robert; Mei, Nan

• FDA Nitrosamine Guidance 2024: Implementation of Control Strategies and Bioequivalence Approaches

  Zuk, Susan; Lu, Dongmei

• Bioequivalence Risk Assessment for Nitrosamine Reducing Reformulations

  Zhao, Liang

• Managing Bioequivalence Risks for Nitrosamine Impacted Drug Products Containing BCS IV Drug Substances

  Zhang, Qi

• Effects of Antioxidants in Drugs Products on Intestinal Drug Transporters

  Yee, SW

• Performance Characteristics of Mass Spectrometry Based Methods for Quantitation of Nitrosamines: Insight from an Inter-laboratory Study

  Yang, Jingyue

• Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS-Based Waiver of In Vivo Bioequivalence Studies

  Wu, Fang

• Physiologically Based Pharmacokinetic (PBPK) Absorption Modeling to Evaluate the Impact of Excipients on Bioequivalence of BCS Class III Drug Products

  Wu, Fang

• Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients

  Van Gessel, Sander

• Assessment of a Diverse Array of Nitrite Scavengers in Solution and Solid State: A Study of Inhibitory Effect on the Formation of Alkyl-Aryl and Dialkyl N-Nitrosamine Derivatives

  Trampuz, M