Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs.

@article{Szebeni2015ComplementAA,
  title={Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs.},
  author={J{\'a}nos G{\'a}bor Szebeni and Gert Storm},
  journal={Biochemical and biophysical research communications},
  year={2015},
  volume={468 3},
  pages={490-7}
}
Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered… CONTINUE READING
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