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COPD: Journal of Chronic Obstructive Pulmonary Disease Volume 14, 2017 - Issue 6
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Original Research

Bioequivalence of a Liquid Formulation of Alpha1-Proteinase Inhibitor Compared with Prolastin®-C (Lyophilized Alpha1-PI) in Alpha1-Antitrypsin Deficiency

Alan F BarkerDepartment of Medicine, Oregon Health and Science University, Portland, Oregon, USA
,
Michael A CamposDepartment of Medicine, University of Miami School of Medicine, Miami, Florida, USA
,
Mark L BrantlyDepartment of Medicine, University of Florida School of Medicine, Gainesville, Florida, USA
,
James M StocksDepartment of Medicine, University of Texas Health Science Center at Tyler, Tyler, Texas, USA
,
Robert A SandhausDivision of Pulmonary, Critical Care Medicine and Sleep, National Jewish Health, Denver, Colorado, USA
,
Douglas LeeDivision of Pulmonary, Allergy, and Sleep Medicine, Wilmington Health, Wilmington, North Carolina, USA
,
Kimberly SteinmannClinical Development, Grifols Therapeutics Inc., Research Triangle Park, North Carolina, USA
,
Jiang LinClinical Development, Grifols Therapeutics Inc., Research Triangle Park, North Carolina, USA
&
Susan SorrellsClinical Development, Grifols Therapeutics Inc., Research Triangle Park, North Carolina, USACorrespondence[email protected]
 show all
Pages 590-596 | Received 26 Jun 2017, Accepted 31 Aug 2017, Published online: 06 Oct 2017

References

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  • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Guidance for industry – statistical approaches to establishing bioequivalence. Rockville (MD): Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services; 2001. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070244.pdf.
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  • Campos MA, Kueppers F, Stocks JM, Strange C, Chen J, Griffin R, et al. Safety and pharmacokinetics of 120 mg/kg versus 60 mg/kg weekly intravenous infusions of alpha-1 proteinase inhibitor in alpha-1 antitrypsin deficiency: a multicenter, randomized, double-blind, crossover study (SPARK). COPD. 2013;10(6):687–95. Epub 2013/07/19. https://doi.org/10.3109/15412555.2013.800852 PMID:23862647

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