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April 01, 2008 (Vol. 28, No. 7)

Regulations Still Driving Stability Testing

Scope of Characterization and Validation Level Should Match the Phase of Development

  • While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the standard and reliable (electrophoresis and chromatography), to the cutting edge (calorimetry), to the downright mysterious (atomic force microscopy). Stability testing is ...

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