PMC/PubMed Indexed Articles
Indexed In
- Academic Journals Database
- Open J Gate
- Genamics JournalSeek
- Academic Keys
- JournalTOCs
- China National Knowledge Infrastructure (CNKI)
- CiteFactor
- Scimago
- Ulrich's Periodicals Directory
- Electronic Journals Library
- RefSeek
- Hamdard University
- EBSCO A-Z
- OCLC- WorldCat
- SWB online catalog
- Virtual Library of Biology (vifabio)
- Publons
- MIAR
- University Grants Commission
- Geneva Foundation for Medical Education and Research
- Euro Pub
- Google Scholar
Useful Links
Share This Page
Journal Flyer
Open Access Journals
- Agri and Aquaculture
- Biochemistry
- Bioinformatics & Systems Biology
- Business & Management
- Chemistry
- Clinical Sciences
- Engineering
- Food & Nutrition
- General Science
- Genetics & Molecular Biology
- Immunology & Microbiology
- Medical Sciences
- Neuroscience & Psychology
- Nursing & Health Care
- Pharmaceutical Sciences
Elambharathy Elangovan
Department of Bioequivalence, Research & Development, Jamjoom Pharmaceuticals, P.O. Box # 6267, Jeddah-21442, Kingdom of Saudi Arabia
Biography
Elambharathy Elangovan works in the Department of Bioequivalence, Research & Development, Jamjoom Pharmaceuticals, P.O. Box # 6267, Jeddah-21442, Kingdom of Saudi Arabia.His current review article mainly focuses on bioequivalence study requirements in the Gulf Cooperation Council countries, European union countries and the United States of America that needs to be fulfilled in order to successfully submit a generic application. This comparison includes the bioequivalence approaches such as study design, sample size, study condition, pharmacokinetic parameters, statistical analysis, narrow therapeutic index drugs, highly variable drug products and BCS based bio waiver requirements.
Publications
-
Mini Review
Bioequivalence Guidelines Requirements for Orally Administered Generics (IR Products) in Gulf Cooperation Council Countries, European Union and United States of America
Author(s): Elambharathy Elangovan*
The importance of the bioequivalence requirements is increasing in the GCC (Gulf Cooperation Council) region pertaining towards the growth of generic drug market. GCC bioequivalence guidelines describes the requirements for bioequivalence study as per this region regulatory requirements. This review article mainly focuses on bioequivalence study requirements in the Gulf Cooperation Council countries, European union countries and the United States of America that needs to be fulfilled in order to successfully submit a generic application. This comparison includes the bioequivalence approaches such as study design, sample size, study condition, pharmacokinetic parameters, statistical analysis, narrow therapeutic index drugs, highly variable drug products and BCS based bio waiver requirements. The rationale for this article is to give prompt overview on the bioequivalence requirements in.. View more»