alexa A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.
Infectious Diseases

Infectious Diseases

Journal of Tropical Diseases & Public Health

Author(s): Chow SC, Hsieh TC, Chi E, Yang J

Abstract Share this page

Abstract For approval of generic drugs, the U.S. Food and Drug Administration (FDA) requires the evidence of bioequivalence in average bioavailability from the bioavailability/bioequivalence studies. The criterion for assessment of bioequivalence adopted by the FDA is a moment-based criterion evaluating log-transformed pharmacokinetic responses such as area under the blood or plasma concentration-time curve (AUC) or maximum concentration (Cmax). Unlike traditional small molecule drug products, the characteristics and development of biologic products are more complicated and sensitive to many factors. Thus, it is of concern to know whether the current bioequivalence criterion is applicable to the assessment of biosimilarity between biologic products. In this article, we compare the moment-based criterion with a probability-based criterion proposed by Tse et al. (2006) for assessment of bioequivalence or biosimilarity between two drug products in terms of consistency/inconsistency for correctly concluding bioequivalence or biosimilarity. A simulation study was conducted to study relative performance of the two criteria. The feasibility and applicability of the proposed criteria for assessment of biosimilarity of follow-on biologics are discussed. This article was published in J Biopharm Stat and referenced in Journal of Tropical Diseases & Public Health

Relevant Expert PPTs

Relevant Topics

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

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

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