pharmacokinetic comparability of prolastin?-c to prolastin? in alpha1-antitrypsin deficiency a randomized study药代动力学的可比性prolastin - c prolastin alpha1-antitrypsin缺乏随机研究.pdfVIP

pharmacokinetic comparability of prolastin?-c to prolastin? in alpha1-antitrypsin deficiency a randomized study药代动力学的可比性prolastin - c prolastin alpha1-antitrypsin缺乏随机研究.pdf

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pharmacokinetic comparability of prolastin?-c to prolastin? in alpha1-antitrypsin deficiency a randomized study药代动力学的可比性prolastin - c prolastin alpha1-antitrypsin缺乏随机研究

Stocks et al. BMC Clinical Pharmacology 2010, 10:13 /1472-6904/10/13 RESEARCH ARTICLE Open Access Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha1-antitrypsin deficiency: a randomized study 1* 2 3 4 5 James M Stocks , Mark L Brantly , Laurene Wang-Smith , Michael A Campos , Kenneth R Chapman , Friedrich Kueppers6 7 8 9 , Robert A Sandhaus , Charlie Strange , Gerard Turino Abstract Background: Alpha -antitrypsin (AAT) deficiency is characterized by low blood levels of alpha -proteinase inhibitor 1 1 (alpha -PI) and may lead to emphysema. Alpha -PI protects pulmonary tissue from damage caused by the action 1 1 of proteolytic enzymes. Augmentation therapy with Prolastin® (Alpha1-Proteinase Inhibitor [Human]) to increase the levels of alpha1-PI has been used to treat individuals with AAT deficiency for over 20 years. Modifications to the Prolastin manufacturing process, incorporating additional purification and pathogen-reduction steps, have led to the development of an alpha -PI product, designated Prolastin®-C (Alpha -Proteinase inhibitor [Human]). The 1 1 pharmacokinetic comparability of Prolastin-C to Prolastin was assessed in subjects with AAT deficiency. Methods: In total, 24 subjects were randomized to receive 60 mg/kg of functionally active Prolastin-C or Prolastin by weekly intravenous infusion for 8 weeks before crossover to the

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