alexa
Reach Us +1-217-403-9671
Importance Of Metabolite Data In Bioequivalence Studies: Sample Size And Power | 19834
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)

5th World Congress on Bioavailability and Bioequivalence Pharmaceutical R&D Summit

Lara Tutunji and Maha Tutunji
Accepted Abstracts: J Bioequiv Availab
DOI: 10.4172/0975-0851.S1.019
Abstract
Purpose: To calculate the sample size and power for the parent compound, the metabolite, and the sum of the parent compound and metabolite in order to determine the role of the metabolite in the decisions made in bioequivalence studies Methods: Data presented were obtained from several bioequivalence studies under fasting conditions for drugs that have active metabolites. The analytical method used was a validated LC-MS/MS method. Bioequivalence criteria of 80-125 % were applied to the parent compound, the active metabolite, and the sum of the parent drug and the active metabolite. Pharmacokinetic data mainly AUC, Tmax, Cmax, and elimination half-life were reported. Results: Similar results were obtained for the parent drug, metabolite, and the sum of the parent drug and metabolite for AUC. In the case of Cmax, the intersubject variability for the metabolite and the sum of the parent and the metabolite was lower than that of the parent drug while the power of the bioequivalence decision was higher for the metabolite and the sum of the parent drug and the metabolite. Conclusions: The power of estimating Cmax using the metabolite data was higher than for the drug alone so a more accurate decision can be made using the metabolite data. As a result of the higher power, the sample size can be lowered accordingly
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 and 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