Methodologies in Biosimilar Product Development is popular PDF and ePub book, written by Sang Joon Lee in 2021-09-30, it is a fantastic choice for those who relish reading online the Mathematics genre. Let's immerse ourselves in this engaging Mathematics book by exploring the summary and details provided below. Remember, Methodologies in Biosimilar Product Development can be Read Online from any device for your convenience.
Methodologies in Biosimilar Product Development Book PDF Summary
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 risk/benefit assessment for non-inferiority/similarity margin, PK/PD 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 Key Features: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.
Detail Book of Methodologies in Biosimilar Product Development PDF
- Author : Sang Joon Lee
- Release : 30 September 2021
- Publisher : CRC Press
- ISBN : 9781000451948
- Genre : Mathematics
- Total Page : 329 pages
- Language : English
- PDF File Size : 17,8 Mb
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