title: Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.
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.
authors.affiliation: Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Lik Hang N
authors.initials: LH
authors.lastname: Lee
authors.affiliation: Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Charles
authors.initials: C
authors.lastname: Choi
authors.affiliation: School of Pharmacy, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Pavel
authors.initials: P
authors.lastname: Gershkovich
authors.affiliation: Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Alasdair M
authors.initials: AM
authors.lastname: Barr
authors.affiliation: Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.|Provincial Health Services Authority, Vancouver, BC, Canada.
authors.forename: William G
authors.initials: WG
authors.lastname: Honer
authors.affiliation: Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada. rprocyshyn@bcmhs.bc.ca.|Provincial Health Services Authority, Vancouver, BC, Canada. rprocyshyn@bcmhs.bc.ca.
authors.forename: Ric M
authors.initials: RM
authors.lastname: Procyshyn
mesh_terms: D065567:Absorption, Physiological; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D019540:Area Under Curve; D001682:Biological Availability; D002081:Buttocks; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000032:analysis / Q000493:pharmacokinetics / Q000627:therapeutic use; D057645:Deltoid Muscle; D005062:European Union; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D001523:Mental Disorders / Q000097:blood / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018687:Antidepressive Agents, Second-Generation; D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations