alexa BCS: A Scientific And Regulatory Tool In Drug Development Process | 22415
ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
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)

3rd International Conference and Exhibition on Biowaivers, Biologics & Biosimilars

Sunita Dahiya
Keynote: J Bioanal Biomed
DOI: 10.4172/1948-593X.S1.012
Abstract
The introduction of the Biopharmaceutics Classification System (BCS) in 1995 was the result of continuous efforts on mathematical analysis for the elucidation of the kinetics and dynamics of the drug process in the gastrointestinal (GI) tract. Since the BCS was introduced, it has been used as a regulatory tool for the replacement of certain bioequivalence (BE) studies with accurate in vitro dissolution tests. This step certainly reduces timelines in the drug development process, both directly and indirectly, and reduces unnecessary drug exposure in healthy volunteers, which is the normal study population in BE studies. BCS also plays a very significant role for the formulation pharmacist in the task of developing a new dissolution method during early investigational stages of formulation design and optimization. Furthermore, BCS based biowaiver can be requested by the sponsor during ANDAs, INDs/NDAs or for significant post approval changes. The BCS enables pharma manufacturers to reduce the cost of approving scale-up and post approval changes (SUPAC) to certain oral drug products and also replacing certain BE studies with accurate in vitro dissolution tests during the process of generic drug development and thus favoring the drug development process by reducing regulatory burden. In this context, BCS seems to be a systematic scientific and regulatory tool that definitely seeking attention in developing the optimal strategies from drug discovery to development.
Biography
Sunita Dahiya completed PhD in Pharmacy from UP Technical University, Lucknow. Presently, she is General Secretary, Association of Pharmacy Professionals (APP) and working as Associate Professor and HOD, Department of Pharmaceutics, Globus College of Pharmacy, Bhopal, MP, India. She has 13 years of experience in academics and guided 30 M.Pharmacy projects. She has published 25 papers in peer reviewed international and national journals and delivered lectures in workshops, conferences and staff development programs. She is reviewer in many international journals including AAPS Pharm SciTech and Clinical Therapeutics, executive editor of APP journal ?Bulletin of Pharmaceutical Research? and Editor-in-Chief of scientific newsmagazine ?APP Scientific Updates?. She has been honored with ?Young Teacher Award? by SPER Women Forum for the year 2014.
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
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- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
Leave Your Message 24x7