Reviews withdrawn draft guidance on analytical similarity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.
General
| Imprint: |
Taylor & Francis
|
| Country of origin: |
United Kingdom |
| Series: |
Chapman & Hall/CRC Biostatistics Series |
| Release date: |
September 2023 |
| Editors: |
Sangjoon Lee
• Shein-Chung Chow
|
| Dimensions: |
234 x 156mm (L x W) |
| Pages: |
380 |
| ISBN-13: |
978-1-03-207180-0 |
| Categories: |
Books
|
| LSN: |
1-03-207180-X |
| Barcode: |
9781032071800 |
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