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.

Abstract

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.

Citation

Lee, L. H. N., Choi, C., Gershkovich, P., Barr, A. M., Honer, W. G., & Procyshyn, R. 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), 659-664. https://doi.org/10.1007/s13318-016-0348-z

• Journal Article Type: Article
• Acceptance Date: May 12, 2016
• Online Publication Date: May 27, 2016
• Publication Date: Dec 1, 2016
• Deposit Date: May 16, 2017
• Journal: European Journal of Drug Metabolism and Pharmacokinetics
• Print ISSN: 0378-7966
• Electronic ISSN: 2107-0180
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 41
• Issue: 6
• Pages: 659-664
• DOI: https://doi.org/10.1007/s13318-016-0348-z
• Public URL: https://nottingham-repository.worktribe.com/output/971646
• Publisher URL: http://link.springer.com/article/10.1007%2Fs13318-016-0348-z
• Additional Information: The final publication is available at Springer via http://dx.doi.org/10.1007/s13318-016-0348-z.
• Contract Date: May 16, 2017