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Biosimilar Drug Product Development (Drugs and the Pharmaceutical Sciences, 216, Band 216) - Hardcover

Buch 62 von 80: Drugs and the Pharmaceutical Sciences
 
9781498718790: Biosimilar Drug Product Development (Drugs and the Pharmaceutical Sciences, 216, Band 216)

Inhaltsangabe

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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Über die Autorin bzw. den Autor

Laszlo Endrenyi, Professor Emeritus, University of Toronto

Von der hinteren Coverseite

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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