Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies.

@article{Borchard2012NanoparticleIM,
  title={Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies.},
  author={Gerrit Borchard and Beat Fl{\"u}hmann and Stefan F M{\"u}hlebach},
  journal={Regulatory toxicology and pharmacology : RTP},
  year={2012},
  volume={64 2},
  pages={
          324-8
        }
}
Currently, most countries apply the standard generic approach for the approval of intended copies of originator nanoparticle iron medicinal products, requiring only demonstration of bioequivalence to a reference medicinal product by bioavailability studies. However, growing evidence suggests that this regulatory approach is not appropriate. Clinical and non-clinical studies have shown that intended copy preparations of nanoparticle iron medicinal products can differ substantially from the… CONTINUE READING
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