alexa
Reach Us +1-217-403-9671
Some Statistical Issues On The Evaluation Of The Similarity And Interchangeability Of Biologics | 8161
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

Like us on:

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)
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Some statistical issues on the evaluation of the similarity and interchangeability of biologics

International Conference and Exhibition on Biowaivers & Biosimilars

Laszlo Endrenyi

ScientificTracks Abstracts: J Bioequiv Availab

DOI: 10.4172/0975-0851.S1.002

Abstract
With the expiry of many patents for biological drugs, biosimilar generic formulations gain increasing interest from regulatory authorities as well as from the biotechnology industry. Unlike small-molecule drugs which can be chemically synthesized, biological drugs are produced by living organisms or cell cultures. They are generally sensitive to environmental factors. New biological products can not be reproduced but only imitated. Consequently, the issues and problems of assessing biosimilarity are much more difficult than those of evaluating the bioequivalence of small-molecule drug products. Similarities of several factors (including complicated structural and functional features, manufacturing conditions, clinical responses) must be taken into account. Statistical assessment is complicated by the usually high variability. An additional issue involves the interchangeability of biologicals which is a distinct concept from their biosimilarity. Study conditions and statistical evaluation will be discussed for comparing drug products of small molecules by bioequivalence and of biologics by biosimilarity. A procedure for the statistical evaluation of biosimilarity will be presented. The interchangeability of small-molecule drugs and of biologics will also be considered.
Biography
Endrenyi is Professor Emeritus of pharmacology and biostatistics in the University of Toronto. He has served the university in various positions including on its Governing Council and as Associate Dean of Graduate Studies. Externally, he has served on grant review committees and editorial boards of research journals including the Amer. J. Physiol, J. Pharmacokin. Pharmacodyn., J. Pharm. Pharm. Sci., Biosimilars, and J. Pharm. Sci. He has received several recognitions, including an honorary doctorate from Semmelweis University. He published a book on Kinetic Data Analysis and over 160 research papers
Top