ISBN-13: 9781138307339 / Angielski / Twarda / 2018 / 354 str.
ISBN-13: 9781138307339 / Angielski / Twarda / 2018 / 354 str.
Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment.