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ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability

Open Access
 
 
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About the Journal

Impact Factor: 1.88*

The Journal of Bioequivalence & Bioavailability (JBB) is an academic journal that encompasses a wide range of current research on FDA Bioequivalence, Bioequivalence antipsychotics, Bioequivalence anticancers, Bioequivalence antidiuretics, Bioequivalence antipsychotics, BA/BE Studies, Biosimilars, Advances in Bioavailability and offers a promising platform for the authors to make their valuable contributions towards the journal.

Journal of Bioequivalence & Bioavailability is the best open access journal that aims to publish most complete and reliable source of information on the discoveries and advanced developments in this field in the form of original articles, review articles, case reports, short communications, etc. and provide free online access to it without any restrictions or any other subscriptions to researchers worldwide. Journal of Bioequivalence & Bioavailability is one of the best Open Access journals of Scholarly publishing.

The Bioequivalence Peer Reviewed Journal is proficiently supported by universally prominent Editorial Board members. Bioequivalence journal impact factor is mainly calculated based on the number of articles that undergo a double blind peer review process by competent Editorial Board so as to ensure excellence, essence of the work and number of citations received for the same published articles.

Submit manuscript at http://editorialmanager.com/jbiobio/ or send as an e-mail attachment to the Editorial Office at editor.jbiobio@omicsonline.org

FDA Bioequivalence

Bioequivalence is 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.

“The FDA guidance is generally applicable to dosage forms intended for oral administration and to non-orally administered drug products in which reliance on systemic exposure measures is suitable for documenting BE.” FDA explains in the guidance ""We believe that the guidance will also be useful when planning BE studies intended to be conducted during the post-approval period for certain changes in an abbreviated new drug application (ANDA).

(1) Under the Federal Food, Drug and Cosmetic Act (FD&C Act, Section 505(j)), generic drug applications must be essentially identical to the drug which they reference, also known as the reference-listed drug (RLD).

(2) Section 505(j)(2)(iv) outlines the basic requirements for conducting bioequivalence studies, and requires ""information to show that the new drug is bioequivalent to the listed drug""-except in cases of a suitability petition-as well as information showing the drug to be of the same pharmacological or therapeutic class, and that it will have the same ""therapeutic effect"" as the RLD. "

Bioequivalence Study Design

It includes randomized, two-period, two-sequence, single dose cross-over design, parallel design and replicate designs. Absolute and Relative bioavailabilty are discussed. Pharmacokinetics and Pharmacodynamics of the study designs make an important role.

Europian Bioequivalence

According to regulations applicable in the European Economic Area [EEA] two medical products are bioequivalent if they are pharmaceutically identical or pharmaceutical options and if their bioavailabilities after administration in the same molar dose are equivalent to such a degree or extent that their effects, with respect to efficacy and safety, will be essentially the same. This is considered demonstrated if the 90% confidence intervals (90% CI) of the ratios for AUC0-t and Cmax between the two preparations lie in the range 80.00 – 125.00%.

Bioequivalence Study Protocols

Both bioavailability and bioequivalence focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation.

Bioavailability and Bioequivalence studies are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product.

Several in vivo and in vitro methods are used to measure product quality.

(1) In vivo studies:

a) Oral immediate release drug formulations with systemic action
b) Non-oral and non-parenteral drug formulations designed to act by systemic absorption
c) Fixed-dose combination products with systemic action.

(2) In vitro studies:

a) Different strengths of the drug manufactured by the same manufacturer.

Anvisa Bioequivalence

The Law no 9787/99, which establishes the generic drug in Brazil, states that the bioequivalence is the demonstration of therapeutical equivalence between two drugs holding a comparable bioavailability that are tried under the same experimental design, thus being an indication of the absorption speed and extension of the drug in its dose form. Since 2001, ANVISA has been publishing several Resolutions to establish criteria and requirements to conduct a bioequivalence Trial to register drugs that have been updated along the development of science.

Bioequivalence Cardiovascular Products

Cardiovascular disease is the leading cause of death and disability in Europe. Several large, population-based trials and their meta-analyses have shown the beneficial effects of statins in reducing mortality and cardiovascular morbidity both primary and secondary prevention. Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending.

Bioequivalence Antidiabetics

Anti-diabetics  are medicines developed to stabilize and control blood glucose levels amongst people with diabetes. Therapeutic drug monitoring necessitates the measurement of their plasma concentration for studying the pharmacokinetics of these drugs, assessment of bioequivalence of commercially available tablet formulation and for optimization of dosing in combination therapy.

Bioequivalence Anticancers

Bioequivalence studies are required to be conducted using cancer patients for biosimilar drugs. Both pharmacokinetic and pharmacodynamic endpoints need to be generally investigated in biosimilar clinical trials. The test and innovative drugs are called bioequivalent if the two drugs have the same bioavailability. A phase I trial should select pharmacodynamic markers that demonstrate the therapeutic efficacy of the drug, and should compare the pharmacodynamic effect of the test and innovative drugs in a population where the possible differences can best be observed.

Bioequivalence Antipsychotics

Antipsychotics (also known as neuroleptics or major tranquilizers) are a class of psychiatric medication primarily used to manage psychosis (including delusions, hallucinations, or disordered thought), in particular in schizophrenia and bipolar disorder. In clinical trials of dopamine-blocking antipsychotics, significant adverse events may occur in healthy volunteers at dose levels that are well tolerated by schizophrenic patients. Because of these differences in tolerability, bioequivalence and pharmacokinetic studies of antipsychotics should be performed in schizophrenic patients rather than in healthy volunteers.

Bioequivalence Antidiuretics

An antidiuretic is an agent or drug that, when administered to an organism, helps control body water balance by reducing urination, opposing diuresis. Antidiuretics are the drugs that reduce urine volume, particularly in diabetes insipidus (DI) which is their primary indication. Bioequivalence was assessed for the primary criterion AUCosm by a calculated mean ratio (test/reference) of 100.9% (90% confidence interval ranging from 88.0% to 115.6%).

In vitro Bioequivalence

The purpose of bioequivalence studies is to reduce toxicological studies and full-scale clinical trials to prove that the product is of good quality, safe and effective. Bioequivalence studies are typically performed after minor changes of a marketed product or by manufacturers of generic drugs. A statistical test is proposed for in vitro bioequivalence testing between drug products. The proposed test generalizes the one recommended in the FDA 1999 guidance to the situation where replicated observations obtained from each sampled canister or bottle of the drug product are available.

Regulatory Requirements in Bioequivalence

The FDA considers two products bioequivalent if the 90% CI of the relative mean Cmax, AUC(0-t) and AUC(0-∞) of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80.00% to 125.00% in the fasting state. Although there are a few exceptions, generally a bioequivalent comparison of Test to Reference formulations also requires administration after an appropriate meal at a specified time before taking the drug, a so-called "fed" or "food-effect" study. A food-effect study requires the same statistical evaluation as the fasting study,

Advances in Bioavailability

In pharmacology, bioavailability (BA) is a subcategory of ingestion and is the part of a managed measurement of unaltered medication that achieves the systemic flow, one of the important pharmacokinetic properties of medications. By definition, when a medicine is directed intravenously, its bioavailability is 100%. Be that as it may, when a medicine is controlled through different courses, (for example, orally), its bioavailability by and large abatements (because of inadequate assimilation and first-pass digestion system) or may fluctuate from patient to patient. Bioavailability is one of the crucial apparatuses in pharmacokinetics, as bioavailability must be considered when computing doses for non-intravenous courses of organization.

BA/BE Studies

BA/BE studies are needed by regulations to guarantee remedial proportionality between a pharmaceutically comparable test item and a reference item. BA/BE studies are finished Early and late clinical trial definitions, Formulations utilized as a part of clinical trial and steadiness studies. Everybody has more heaped on their plate than any time in recent remembrance, and numerous consultant discover themselves always re-organizing their work exercises.

Biosimilars

A biosimilar is a biologic therapeutic item which is duplicate of a unique item that is produced by an alternate organization. Biosimilars are authoritatively sanction forms of unique "discoverer" items, and can be produced when the first item's patent terminates. Reference to the pioneer item is a fundamental part of the approbation.

BABE-2015 The Bioavailability Bioequivalence Research Center aims to become a regional center of excellence for assuring the safety and efficacy of generic pharmaceutical products for human use. It plays a key role in the drug development period for both new drug products and their generic equivalents. These studies are also important in the post approval period in the presence of certain manufacturing changes. Information in the overall set of data that ensure the availability of safe and effective medicines to patients and practitioners.

6th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit The most awaited event would be staged during August 17-19, 2015 Chicago, USA.

*Unofficial 2014 Impact Factor was established by dividing the number of articles published in 2012 and 2013 with the number of times they are cited in 2014 based on Google search and the Scholar Citation Index database. If ‘X’ is the total number of articles published in 2012 and 2013, and ‘Y’ is the number of times these articles were cited in indexed journals during 2014 than, impact factor = Y/X

 

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