bokomslag Methodologies in Biosimilar Product Development
Kropp & själ

Methodologies in Biosimilar Product Development

Sang Joon Lee Shein-Chung Chow

Pocket

939:-

Funktionen begränsas av dina webbläsarinställningar (t.ex. privat läge).

Uppskattad leveranstid 10-15 arbetsdagar

Fri frakt för medlemmar vid köp för minst 249:-

Andra format:

  • 380 sidor
  • 2023
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 Key Features: Reviews withdrawn draft guidance on analytical similarity assessment.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 FDAs 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.
  • Författare: Sang Joon Lee, Shein-Chung Chow
  • Illustratör: black and white 91 Illustrations 100 Tables, black and white 91 Line drawings black and white
  • Format: Pocket/Paperback
  • ISBN: 9781032071800
  • Språk: Engelska
  • Antal sidor: 380
  • Utgivningsdatum: 2023-09-25
  • Förlag: Chapman & Hall/CRC