DOWNLOAD YOUR ESSENTIAL GUIDE IN BIOSIMILAR DEVELOPMENT FOR FREE

Everything You Need to Know About Biosimilar Study Design and Analysis

3-part SCIENTIFIC COURSE presentation
by Prof. Shein-Chung Chow, PhD

Professor at Duke University School of Medicine
The lectures are available only for members who are signed-up by 22th of SEPTEMBER. Courtesy of Annual Biosimilars Forum event series.


START TO LEARN FROM A RENOWED EXPERT OF BIOSIMILARS

Inside you will find the presentation materials of the lectures from the 3-part scientific course entitled The Design and Analysis of Biosimilar Studies, instructed by Professor Shein-Chung Chow at the 1st Biosimilars Forum in Budapest.

This lecture series provide a detailed overview of hot development issues of follow-on biologics and guidance for their handling, including

US FDA’s regulatory requirements
Scientific key factors for assessing biosimilarity
Development of biosimilarity index
Statistical methods, issues, designs for assessing interchangeability
Guides of analytical similarity assessment in Biosimilar Studies

Sign up for the Lecture series now by filling out this form! We will email you your copies of the lectures within 1 business day.

Lecture 1 (67-page):
Assessing Biosimilarity: Issues and Recent Development

Lecture 2 (62-page):
Assessing Interchangeability: Issues, Designs, and Statistical methods

Lecture 3 (65-page):
Analytical Similarity Assessment in Biosimilar Studies

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About Prof. Shein-Chung Chow, PhD

Professor, Biostatistics and Bioinformatics, Duke University School of Medicine, USA
Special Government Employee and statistical consultant of the US FDA;
Editor-in-Chief of the: Journal of Biosimilars; the Journal of Biopharmaceutical Statistics and the Drug Designing,
More than 30 years of experience in pharmaceutical/clinical development
• Author or co-author of over 280 methodology papers and 24 books including Biosimilars: Design and Analysis of Follow-on Biologics (Chapman and Hall/CRCPress, New York, 2013)

The above 3-part scientific lecture series entitled Design and analysis of biosimilar studies was instructed by Prof. Chow at the 1st Biosimilars Forum on 6 October, 2016 in Budapest. The materials of the course are developed based on

• the book entitled “Biosimilars: Design and Analysis of Follow-on Biologics” by Chow SC published in 2013 by Chapman and Hall/CRCPress, Taylor & Francis, New York,
• and the 3rd edition of the book entitled “Design and Analysis of Bioavailability and Bioequivalence Studies” by Chow SC and Liu JP published in 2008 by Chapman and Hall/CRC Press, Taylor & Francis, New York.

About the goal of the Annual Biosimilars Forum event series


The Annual Biosimilars Forum event series was founded in 2016 by two prestigious Central European scientific societies, the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics in cooperation with the Accelsiors CRO Ltd.. The organizers aimed at increasing effectiveness of clinical research and in order to provide even more effective support in sharing of recent scientific and practical knowledge for biosimilar development professionals. The Annual Biosimilar Forum provides an opportunity for a constructive and open dialogue between regulatory professionals, clinical researchers, medical statisticians and pharmaceutical developers.

This special offer regarding to the free download of the course materials of the Design and analysis of biosimilar studies by Professor Shein-Chung Chow is available for all professionals who are interested in the biosimilar development topic except for the employees of professional CRO companies.

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