Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)

ISBN 10: 103207180X ISBN 13: 9781032071800

Verlag: Chapman and Hall/CRC, 2023

Sprache: Englisch

Neu Zustand: New Softcover

F�r sp�ter vormerken

Verk�ufer Ria Christie Collections, Uxbridge, Vereinigtes K�nigreich

Verk�uferbewertung 5 von 5 Sternen

AbeBooks-Verk�ufer seit 25. M�rz 2015

Alle Artikel dieses Verk�ufers anzeigen

Alle Exemplare dieses Buches anzeigen

Neu - Softcover

Preis: EUR 69,97 W�hrung umrechnen

EUR 5,85 f�r den Versand von Vereinigtes K�nigreich nach Deutschland Versandziele, Kosten & Dauer

Anzahl: Mehr als 20 verf�gbar

In den Warenkorb legen

F�r sp�ter vormerken

Beschreibung

In. Bestandsnummer des Verk�ufers ria9781032071800_new

Verk�ufer kontaktieren

Diesen Artikel melden

Bibliografische Details

Titel: Methodologies in Biosimilar Product ...

Verlag: Chapman and Hall/CRC

Erscheinungsdatum: 2023

Einband: Softcover

Zustand: New

�ber diesen Titel

Inhaltsangabe:

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Reviews withdrawn draft guidance on analytical similarity assessment.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.

�ber die Autorin bzw. den Autor:

Sang Joon Lee, Ph.D., is a Senior Executive Vice President at Celltrion, inc. Dr. Lee was previously an assistant Professor at the University of New Mexico School of Medicine, and a Research Associate and Statistical Analyst at The University of Texas, M.D. Anderson Cancer Center. He received the B.S. degree in Statistics from Inha University, the M.S. degree in Statistics from the Seoul National University, and the Ph.D. degree in Statistics from Texas A&M University. Dr. Lee has authored or co-authored over 100 research papers and invited papers.

Shein-Chung Chow, Ph.D., is a Professor at Duke University School of Medicine. Dr. Chow was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Executive Director at Covance, and Director and Department Head at Bristol-Myers Squibb. He received the B.S. degree in mathematics from East China Normal University, and the Ph.D. degree in Statistics from the University of Wisconsin-Madison. Dr. Chow has authored or co-authored over 310 methodology papers and 31 books.

��ber diesen Titel� kann sich auf eine andere Ausgabe dieses Titels beziehen.

Anbieterinformationen

Hello! Ria Christie Collections is an online venture that was initially set up in 2012 to sell books. We do not have a physical high street store. We are professional online booksellers. We only sell brand new books in perfect condition that we source from various suppliers and the publishers. Primarily, our aim is to provide an excellent service to all our customers. We always work as a team to achieve this. Our other objectives are to: 1. Ensure that all our products reach their destination quickly in a safe and secure manner 2. Answer to all our customer queries within 24 hours 3. Ensure that our customers are happy with their purchases 4. Provide all the items at a competitive price 5. Always listen to our customers Ria Christie Collections is not a registered company. It is a Sole Trader venture. Other key information is shown below: Contact Person Name: Rakesh Luchmun (Mr) Storefront Name: Ria Christie Collections Place of Establishment Address: Suite B; ARUN House; ARUN Building Arundel Road Uxbridge UB8 2RR United Kingdom E-Mail Address: riachristie@hotmail.co.uk VAT Number: GB 160 5650 25 We always work hard and aim to comply with all of Abebooks Policies. If you have any issues, please do not hesitate to write to us whether before or after a purchase. We promise to reply to you promptly and, in any case, within 24 hours. Thank you kindly! Yours sincerely Mr Rakesh Luchmun (Founder) and the Ria Christie Collections Team

Zur Homepage des Verk�ufers

Unternehmensdaten des Verk�ufers

Ryefield Investments Limited
175 Pield Heath Road, Uxbridge, UB8 3NL, United Kingdom

Gesch�ftsbedingungen:

All Returns and Refund are as per Abebooks policies.

Versandinformationen:

Orders usually ship within 2 business days. If your book order is heavy or oversized, we may contact you to let you know extra shipping is required. Thank you!

Zahlungsarten
akzeptiert von diesem Verk�ufer

Zu Kaufgesuchen hinzuf�gen

Verwandte Artikel zu Methodologies in Biosimilar Product Development (Chapman...

Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)

Neu - Softcover

Unternehmensdaten des Verk�ufers