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As per available reports about 38 relevantJournals, 4 Conferences, 3 Workshops are presently dedicated exclusively to bioavailability and about 388 articles are being published on bioavailability.
Bioavailability focuses on the processes by which the active ingredients or moieties are released from an oral dosage form and move to the site of action. From a pharmacokinetic perspective, BA data for a given formulation provide an estimate of the relative fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the BA data for a solution, suspension, or intravenous dosage form. In addition, BA studies provide other useful 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.
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Scope and Importance:
Bioavailability Conference provides the scope for opportunities to learn progressed by international scientists and academicians. Bioequivalence can be considered to be one aspect of product quality that provides a link to the performance of the drug product used in clinical trials and to the database containing evidence of safety and efficacy.
The United States Food and Drug Administration (FDA) has defined Bioavailability 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.
This definition focuses on the processes by which the active ingredients or moieties are released from an oral dosage form and move to the site of action. From a pharmacokinetic perspective, BA data for a given formulation provide an estimate of the relative fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the BA data for a solution, suspension, or intravenous dosage form. In addition, BA studies provide other useful 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. BA data can also provide information indirectly about the properties of a drug substance before entry into the systemic irculation, such as permeability and the influence of presystemic enzymes and/or transporters (e.g., p-glycoprotein).BA for orally administered drug products can be documented by developing a systemic exposure profile. A profile can be obtained by measuring the concentration of active ingredients and/or active moieties and, when appropriate, its active metabolites over time in samples collected from the systemic circulation. Systemic exposure patterns reflect both release of the drug substance from the drug product and a series of possible presystemic/systemic actions on the drug substance after its release from the drug product. We recommend that additional comparative studies be performed to understand the relative contribution of these processes to the systemic exposure pattern.
One regulatory objective is to assess, through appropriately designed BA studies, the performance of the formulations used in the clinical trials that provide evidence of safety and efficacy .Before marketing a drug product, the performance of the clinical trial dosage form can be optimized, in the context of demonstrating safety and efficacy. The systemic exposure profiles of clinical trial material can be used as a benchmark for subsequent formulation changes and can be useful as a reference for future BE studies. Although BA studies have many pharmacokinetic objectives beyond formulation performance as described above, we note that subsequent sections of this guidance focus on using relative BA (referred to as product quality BA) and, in particular, BE studies as a means to document product quality. In vivo performance, in terms of BA/BE, can be considered to be one aspect of product quality that provides a link to the performance of the drug product used in clinical trials and to the database containing evidence of safety and efficacy.
Market Analysis:
An overview of the global market of drugs, including coverage of therapeutics such as antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs sector is expected to grow to $38.8 billion in 2018, with a compound annual growth rate (CAGR) of 27.2% from 2013 to 2018.
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This page was last updated on November 22, 2024
