alexa Statistical Designs for Assessing Interchangeability of Biosimilar Products
ISSN: 2169-0138

Drug Designing: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Research Article

Statistical Designs for Assessing Interchangeability of Biosimilar Products

Lu Y1*, Chow SC2 and Zhang ZZ3
1College of Applied Sciences, Beijing University of Technology, Beijing, China
2Duke University School of Medicine, Durham, North Carolina, USA
3College of Applied Sciences, Communication University of China, Beijing, China
Corresponding Author : Lu Y
College of Applied Sciences
Beijing University of Technology
Beijing, China
E-mail: zhtongl@hotmail.com
Received July 22, 2013; Accepted September 20, 2013; Published October 01, 2013
Citation: Lu Y, Chow SC, Zhang ZZ (2013) Statistical Designs for Assessing Interchangeability of Biosimilar Products. Drug Des 3:109. doi:10.4172/2169-0138.1000109
Copyright: © 2013 Lu Y, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

More and more biopharmaceutical and/or biotech companies begin to concern regulatory approval of biosimilar products, due to some innovator products will expire in decades. Once more biological products are going off patient, the problem whether approving biosimilar products used interchangeably and safely will be considered. Using a biological product of the reference product interchangeably, the United States Food and Drug Administration (FDA) requires that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product, is not greater than the risk of using the reference product without such alternation or switch. For this purpose, based on the concept of switching and/or alternation several useful designs for assessing drug interchangeability are proposed. In addition, by developed biosimilarity index, a uni?ed approach is discussed. The proposed method is robust against biosimilarity criteria and is applicable under a valid and appropriate study design.

Share This Page

Additional Info

Loading
Loading Please wait..
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

agriaquaculture@omicsonline.com

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

biochemjournals@omicsonline.com

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

business@omicsonline.com

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

chemistryjournals@omicsonline.com

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

clinicaljournals@omicsonline.com

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

engineeringjournals@omicsonline.com

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

nutritionjournals@omicsonline.com

1-702-714-7001Extn: 9042

General Science

Andrea Jason

generalscience@omicsonline.com

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

geneticsmolbio@omicsonline.com

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

immunomicrobiol@omicsonline.com

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

materialsci@omicsonline.com

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

nursinghealthcare@omicsonline.com

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

medicaljournals@omicsonline.com

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

neuropsychology@omicsonline.com

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

pharmajournals@omicsonline.com

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

social_politicalsci@omicsonline.com

1-702-714-7001Extn: 9042

 
© 2008- 2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords