Methodologies In Biosimilar Product Development - Taylor & Francis Ltd

Methodologies For Biosimilar Product Development Covers The Practical And Challenging Issues That Are Commonly Encountered During The Development, Review, And Approval Of A Proposed Biosimilar Product. These Practical And Challenging Issues Include, But Are Not Limited To The Mix-up Use Of Interval Hypotheses Testing (i.e., The Use Of Tost) And Confidence Interval Approach, A Riskbenefit Assessment For Non-inferioritysimilarity Margin, Pkpd Bridging Studies With Multiple References, The Detection Of Possible Reference Product Change Over Time, Design And Analysis Of Biosimilar Switching Studies, The Assessment Of Sensitivity Index For Assessment Of Extrapolation Across Indications Without Collecting Data From Those Indications Not Under Study, And The Feasibility And Validation Of Non-medical Switch Post-approval. Key Features: Reviews Withdrawn Draft Guidance On Analytical Similarity Assessment.