Methodologies in Biosimilar Product Development
Download or Read eBook Methodologies in Biosimilar Product Development PDF written by Sang Joon Lee and published by CRC Press. This book was released on 2021-09-30 with total page 393 pages. Available in PDF, EPUB and Kindle.
| Author | : Sang Joon Lee |
| Publisher | : CRC Press |
| Total Pages | : 393 |
| Release | : 2021-09-30 |
| ISBN-10 | : 9781000451917 |
| ISBN-13 | : 1000451917 |
| Rating | : 4/5 (17 Downloads) |
Book Synopsis Methodologies in Biosimilar Product Development by : Sang Joon Lee
Book excerpt: Reviews withdrawn draft guidance on analytical similarity assessment.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.
