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Editorial - (2009) Volume 1, Issue 1

Journal of Bioequivalence & Bioavailability

Huixiao Hong1, George Perry2, Fritz Sörgel3, Srinubabu Gedela4 and Sudhakar Akulapalli5
1Division of Systems Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, US
2Dean and Professor College of Sciences, University of Texas at San Antonio, United States
3IBMP - Institute for Biomedical and Pharmaceutical Research, Paul-Ehrlich-Straße 19, 90562 Nürnberg-Heroldsberg, Germany
4Institute of Glycoproteomics & Systems Biology, India, Stanford University School of Medicine, USA
5Cell Signaling and Tumor Angiogenesis Laboratory, Boys Town National Research Hospital, USA

What is the Journal of Bioequivalence & Bioavailability (JBB)?

Journal of Bioequivalence & Bioavailability (JBB) open access is a peer reviewed, international, interdisciplinary scholarly open access journal of its field. JBB is one and only the open access journal in bioequivalence and bioavailability with academic support from leading research institutes and industries. JBB aims to be an evidence-based force for the advancement of bioequivalence and bioavailability studies. An Open access online version of JBB is published by the OMICS Publishing Group, an international open access publisher for the advancement of Science & Technology.

JBB publishes, but is not limited to, ethical issues involved in bioequivalence study, sample preparation for analysis, bioequivalence study and data interpretation, sample preparation techniques for bioanalysis, analytical methodology development for quantification drugs, HPLC and LC-MS/MS methodologies for quantification of drugs and pharmaceuticals in different body fluids, bioanalytical method validation and validation parameters, bioavailability reports in humans and animals, microdialysis and its applications in bioavailability, drug delivery and kinetic studies, pharmacokinetics, pharmacodynamics, systems clinical and toxicological analysis.

What is Bioequivalence & Bioavailability?

Bioavailability is defined in the US FDA’s Guidance for Industry as: the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. Bioequivalence is defined as: the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

Bioavailability studies assess the relative fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the bioavailability data for a solution, suspension, or intravenous dosage form and provide pharmacokinetic information related to distribution, elimination, the effects of nutrients on absorption of the drug, dose proportionality, linearity in pharmacokinetics of the active moieties and, where appropriate, inactive moieties. The purpose of bioequivalence studies is to demonstrate bioequivalence between a pharmaceutically equivalent generic drug product and the corresponding reference listed drug. Together with the determination of pharmaceutical equivalence, establishing bioequivalence allows a regulatory conclusion of therapeutic equivalence. Bioequivalence studies compare the systemic exposure profile of a test drug product to that of a reference drug product.

Why a New Journal?

JBB has been founded to meet the demand and phenomenal growth of bioequivalence and bioavailability studies, and no journal is available under the titles of bioequivalence and bioavailability particularly under open access category. The main motto for the journal is to bring all scattered bioequivalence reports under one open access platform. Open access publication is the best solution for dissemination of significant output of human endeavors. Under open access platform, JBB is an adventurous venue to the scientists of its field and will become a treasure trove for the bioequivalence and bioavailability reports. To better serve readers, authors, reviewers, and editors, JBB strives to ensure and publish the best possible scientific outputs. Published articles reach thousands of readers by E-mail immediately upon publication. In today's wired world, information is available at the click of the button, courtesy the Internet. JBB -Open Access gives a worldwide audience larger than that of any subscription-based journal in the field of life sciences, no matter how prestigious or popular, and provably increases the visibility and impact of published work. JBB - Open Access gives barrier-free access to the literature for research. It increases convenience, reach, and retrieval power. Free online literature is available online for data software that facilitates full-text searching, indexing, mining, summarizing, translating, querying, linking, recommending, alerting, "mash-ups" and other forms of processing and analysis. JBB - Open Access puts rich and poor on an equal footing for these key resources and eliminates the need for permissions to reproduce and distribute content.



Copyright: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.