{"product_id":"analytical-similarity-assessment-in-biosimilar-product-development","title":"Analytical Similarity Assessment in Biosimilar Product Development","description":"\u003cp\u003eThis book 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 covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models\/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Default Title","offer_id":45589336981742,"sku":"9780367733834","price":84.0,"currency_code":"AUD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0630\/9612\/7726\/files\/9780367733834_c91f041b-0888-4c48-9fed-50bc8c5d45ad.jpg?v=1721221910","url":"https:\/\/bookland.com.au\/products\/analytical-similarity-assessment-in-biosimilar-product-development","provider":"Book Land AU","version":"1.0","type":"link"}