Studies on tissue specific carcinogenicity and on metabolism of N-nitrosamines (SC05 to FWC EMA/2020/46/TDA/L1.02 – ROC38))

Study type

• Study topic:
  Other
• Study topic, other:
  Evaluate tissue specific carcinogenicity and on metabolism of N-nitrosamines
• Study type:
  Not applicable
• Scope of the study:
  Method development or testing
• If ‘other’, further details on the scope of the study:
  Research project to better define threshold for nitrosamine impurities

Study drug and medical condition

• Medicinal product name, other:
  Several model compounds with nitrosmine substructure

Population studied

• Short description of the study population:
  none
• Special population of interest:
  Other
• Special population of interest, other:
  no patients involved
• Estimated number of subjects:
  0