Bioequivalence evaluation of epinephrine autoinjectors with attention to rapid delivery

Figures & data

Table 1 Baseline corrected results for comparison of Auvi-Q™ (Sanofi, Bridgewater, NJ, USA) to EpiPen^® (Mylan Specialty LP, Basking Ridge, NJ, USA) autoinjectors

		90% confidence interval
PK parameters	Ratio	Lower	Upper	μT − μR	σWR^2	Upper 95% confidence limit for (μT − μR)^2 − 0.8 σWR^2	CVWR (%)	Criterion 1: confidence limit	Criterion 2: point estimate	Bioequivalent
Cmax	0.9446	0.8439	1.0844	−0.0570	0.1931	−0.1046	43.94	Pass	Pass	Yes
AUC0–t	1.1544	1.0575	1.2774	0.1436	0.1279	−0.0373	35.76	Pass	Pass	Yes
AUCinf	1.1747	1.0915	1.3693	0.1610	0.1250	−0.0179	35.36	Pass	Pass	Yes
R1ACOTMX	0.7635	0.6549	0.9219	−0.2698	0.3494	−0.0686	59.11	Pass	Fail	No
R2ACOTMX	0.7896	0.6585	0.9532	−0.2362	0.3154	−0.0670	56.16	Pass	Fail	No

Note: Adapted from Center for Drug Evaluation and Research. Application Number: 201739Orig1s000. Clinical Pharmacology and Biopharmaceutics Review(s). Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739Orig1s000ClinPharmR.pdf. Accessed February 1, 2013.⁷

Abbreviations: AUC_0–t, area under the concentration–time curve from baseline to last measurable concentration in ng · h/mL; AUC_inf, area under the concentration–time curve from baseline extrapolated to infinity in ng · h/mL; C_max, peak drug concentration in ng/μL; CV_WR, coefficient of variation for reference (EpiPen^®) in percent; PK, pharmacokinetic; R1ACOTMX, partial AUC based on zero to T_max after first administration in ng · h/mL; R2ACOTMX, partial AUC based on zero to T_max after second administration in ng · h/mL; T_max, time at maximum plasma concentration in hours; μ_R, mean of reference (EpiPen); μ_T, mean of test (Auvi-Q); σ_WR², intrasubject variability for reference.

Center for Drug Evaluation and ResearchApplication Number: 201739Orig1s000Clinical Pharmacology and Biopharmaceutics Review(s) Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739Orig1s000ClinPharmR.pdfAccessed February 1, 2013

 Google Scholar