Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins.

@article{Rosenberg2012ManagingUA,
  title={Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins.},
  author={Amy S. Rosenberg and Daniela Verthelyi and Barry W. Cherney},
  journal={Journal of pharmaceutical sciences},
  year={2012},
  volume={101 10},
  pages={3560-7}
}
The critical question addressed in this paper regards how industry and regulatory agencies should manage the risk of adverse events to patients posed by product quality attributes for which a preponderance of evidence from clinical and/or non-clinical studies supports it as a risk, but for which the probability of clinical adverse events arising from the attribute is uncertain. We here provide our perspective on the principles that can be applied to determine the need for and the manner in… CONTINUE READING

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Nutropin depot and immunogenicity

V Quarmby
2010

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