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Following on from the NorthStar Report which analysed the first 121 Centralised Products approved by EMA, Kinesys has produced a database of all approved Oncology products by EMA since 1995. This includes all of the Orphan Medicinal Products in this therapeutic area. Detailed analyses of products include:

  • Timings of approvals
  • Rapporteur assessors
  • Variations / line extensions
  • Toxicology and Pharmacokinetics: a review of studies conducted and key features and issues
  • Clinical: a review of studies conducted with design features, sample sizes key results, total patient numbers for approval, numbers of phase 3 and other studies

Bespoke analyses can be done:

  • On specific products and their development programmes
  • Across therapeutic groups for any component of the database
  • Comparisons of timings, trends of Rapporteurs by product type
  • Preclinical study requirements by product type / therapeutic area
  • Clinical study trends and requirements for approval – sample sizes, design features

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