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)

• Hydrochlorothiazide – a twist in the tail

  Teasdale, Andrew

• Effects of Antioxidants in Drugs Products on Intestinal Drug Transporters

  Yee, S

• Effectiveness of Antioxidants in Selected Model Drugs: Mitigation Strategy and Impact of Reformulation in their Stability

  Shakleya, Diaa

• Why Do Nitrosamine Potencies Vary So Widely? Mechanistic Rationales for the Effects of Structural Features on Activity

  Ponting, David

• Position Papers for Classes of NDSRIs

  Nudelman, Raphael

• Distilling a Complex Problem into Quantitative Tools and Approaches to Address N-nitrosamine Formation Risk in Drug Products

  Moser, Justin

• FDA Guidance – Control of Nitrosamines in Human Drugs

  Lu, Dongmei

• Using Structure-Activity Relationships to Inform Setting Acceptable Intakes for Nitrosamine Impurities

  Kruhlak, Naomi

• Nitrosamine Drug Impurities and Nitrosamine Drug Substance Related Impurities: Optimizing Mutagenicity Testing

  Heflich, Robert

• FDA/NCTR activities: Ames optimization effort and in vitro alternatives

  Heflich, Robert