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Biosimilar Drug Product Development

Bag om Biosimilar Drug Product Development

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9781498718790
  • Indbinding:
  • Hardback
  • Sideantal:
  • 496
  • Udgivet:
  • 7. marts 2017
  • Størrelse:
  • 247x165x32 mm.
  • Vægt:
  • 908 g.
  • 8-11 hverdage.
  • 21. november 2024
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Beskrivelse af Biosimilar Drug Product Development

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

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