Biosimilar Development: Principles and Pitfalls

Making a biosimilar requires gifted researchers to lead ventures in a lab that require an abnormal state of accuracy. Advanced scientific instruments and strategies are utilized to contrast the biosimilar with the reference item on the fine subtle elements of the particle. Much of the time, a hearty expository information bundle is inadequate for endorsement without non– clinical and clinical information. The explanatory information with the non– clinical and clinical information together contain the "totality of confirmation" for which the level of similitude can be surveyed

  • Flexible and Cost-Effective Manufacture of High Quality Biosimilars
  • Key Aspects in Technical Development
  • Designing and conducting clinical trials for Biosimilars
  • Biosimilars Development and Impact on Clinical Practice
  • The analytical strategies of protein characterisation of Biosimilars
  • Key Aspects in Technical Development
  • Biomanufacturing Capacity for Biosimilars: Is There Enough?
  • Biosimilars Uptake & Patient Safety
  • Pharmacovigilance & Safety of Biosimilars
  • Clinical Trials in Biosimilars

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