Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics

The maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between...

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Main Authors: Lee, Lik Hang N., Choi, Charles, Gershkovich, Pavel, Barr, Alasdair M., Honer, William G., Procyshyn, Ric M.
Format: Article
Published: Springer 2016
Online Access:https://eprints.nottingham.ac.uk/42880/
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author Lee, Lik Hang N.
Choi, Charles
Gershkovich, Pavel
Barr, Alasdair M.
Honer, William G.
Procyshyn, Ric M.
author_facet Lee, Lik Hang N.
Choi, Charles
Gershkovich, Pavel
Barr, Alasdair M.
Honer, William G.
Procyshyn, Ric M.
author_sort Lee, Lik Hang N.
building Nottingham Research Data Repository
collection Online Access
description The maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics.
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spelling nottingham-428802020-05-04T19:59:46Z https://eprints.nottingham.ac.uk/42880/ Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics Lee, Lik Hang N. Choi, Charles Gershkovich, Pavel Barr, Alasdair M. Honer, William G. Procyshyn, Ric M. The maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics. Springer 2016-12 Article PeerReviewed Lee, Lik Hang N., Choi, Charles, Gershkovich, Pavel, Barr, Alasdair M., Honer, William G. and Procyshyn, Ric M. (2016) Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics. European Journal of Drug Metabolism and Pharmacokinetics, 41 (6). pp. 659-664. ISSN 2107-0180 http://link.springer.com/article/10.1007%2Fs13318-016-0348-z doi:10.1007/s13318-016-0348-z doi:10.1007/s13318-016-0348-z
spellingShingle Lee, Lik Hang N.
Choi, Charles
Gershkovich, Pavel
Barr, Alasdair M.
Honer, William G.
Procyshyn, Ric M.
Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
title Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
title_full Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
title_fullStr Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
title_full_unstemmed Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
title_short Proposing the use of partial AUC as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
title_sort proposing the use of partial auc as an adjunctive measure in establishing bioequivalence between deltoid and gluteal administration of long-acting injectable antipsychotics
url https://eprints.nottingham.ac.uk/42880/
https://eprints.nottingham.ac.uk/42880/
https://eprints.nottingham.ac.uk/42880/