Methodologies in Biosimilar Product Development

Name: Methodologies in Biosimilar Product Development
Brand: Taylor & Francis Ltd
SKU: 9781032071800
Price: 288.94 PLN
Availability: InStock

Autor: Sang Joon Lee, Shein-Chung Chow

Język:

Oprawa: Miękka

Wydawca: Taylor & Francis Ltd

Dostępność: Dostępna u dostawcy

Wysyłamy za 9-15 dni

288.94 zł

Methodologies for Biosimilar Product Development covers the practical and challenging issues that ar...

Informacje o książce

Autor

Sang Joon Lee, Shein-Chung Chow

Język

Angielski

Oprawa

Książka - Miękka

Data wydania

2023

strony

380

EAN

9781032071800

Enbook ID

43908221

Wydawca

Taylor & Francis Ltd

Waga

453

Wymiary

156 x 234

Pełny opis

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Reviews withdrawn draft guidance on analytical similarity assessment.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.

Możesz być zainteresowany

Klienci, którzy kupili tę książkę, kupili również

Najczęściej wyszukiwane

Categories

Authors

Publishers

Produkty

Produkty

Najczęściej wyszukiwane

Categories

Authors

Publishers

Produkty

Produkty

Methodologies in Biosimilar Product Development

Informacje o książce

Pełny opis

Możesz być zainteresowany

Structures in Science

Hawaiian Honeycreepers

Industrial Transformation of Subarctic Canada

Abroad

Diamond's Reign

Bee Clever Series: Phonics - Book 1

Alison's Adventures: Your Passport to the World

Klienci, którzy kupili tę książkę, kupili również

Gestión de inventario en la empresa de transporte por carretera