Description
- Reviews withdrawn draft guidance on analytical similarity assessment.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.
Book Information
ISBN 9781032071800
Author Sang Joon Lee
Format Paperback
Page Count 380
Imprint Chapman & Hall/CRC
Publisher Taylor & Francis Ltd