References
- . Buckley RH. Primary immunodeficiency diseases due to defects in lymphocytes. N Engl J Med. 2000;343(18):1313–1324
- . Notarangelo L, Casanova JL, Fischer A, . Primary immunodeficiency diseases: an update. J Allergy Clin Immunol. 2004;114(3):677–687
- . Hagan JB, Fasano MB, Spector S, . Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration. IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010;30(5):734–745
- . Jolies S, Bernatowska E, de Gracia J, . Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011;141(1):90–102
- . Bonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin North Am. 2008;28(4):803–19, ix
- . Ochs HD, Gupta S, Kiessling P, . Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26(3):265–273
- . Pfister M, D'Argenio DZ. The emerging scientific discipline of pharmacometrics. J Clin Pharmacol. 2010;50( 9 Suppl):6S
- . US Food and Drug Administration. Challenges and opportunity on the critical path to new medical products; 2004. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathlnitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Accessed September 16, 2013
- . Lee JY, Garnett CE, Gobburu JV, . Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet. 2011;50(10):627–635
- . Duan JZ. Applications of population pharmacokinetics in current drug labelling. J Clin Pharm Ther. 2007;32(1):57–79
- . Yim DS, Zhou H, Buckwalter M, . Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol. 2005;45(3):246–256
- . Wasserman RL, Irani AM, Tracy J, . Pharmacokinetics and safety of subcutaneous immune globulin (human), 10% caprylate/chromatography purified in patients with primary immunodeficiency disease. Clin Exp Immunol. 2010;161(3):518–526
- . Tornoe CW, Tworzyanski JJ, Imoisili MA, . Optimising piperacillin/tazobactam dosing in paediatrics. Int J Antimicrob Agents. 2007;30(4):320–324
- . Madabushi R, Cox DS, Hossain M, . Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics. J Clin Pharmacol. 2011;51(1):19–28
- . Aydogan M, Eifan AO, Gocmen I, . Clinical and immunologic features of pediatric patients with common variable immunodeficiency and respiratory complications. J Investig Allergol Clin Immunol. 2008;18(4):260–265
- . Borte M, Quinti I, Soresina A, . Efficacy and safety of subcutaneous Vivaglobin replacement therapy in previously untreated patients with primary immunodeficiency: a prospective, multicenter study. J Clin Immunol. 2011;31(6):952–961
- . Bonate PL. Pharmacokinetic-Pharmacodynamic Modeling and Simulation. New York, NY: Springer; 2011
- . Gustafson R, Gardulf A, Hansen S, . Rapid subcutaneous immunoglobulin administration every second week results in high and stable serum immunoglobulin G levels in patients with primary antibody deficiencies. Clin Exp Immunol. 2008;152(2):274–279
- . Hizentra [product information (EU SPC)]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002127/WC500107057pdf. Accessed June 27, 2013
- . Privigen [product information (EU SPC)]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/00083l/WC500043077pdf. Accessed June 27, 2013
- . Hizentra [package insert]. http://www.fda.gov/downloads/AboutFDA/CentersOffice/OfficeofMedicalProductsandTobacco/CBERUCM308554.pdf. Accessed June 27, 2013
- . Privigen [package insert]. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM303092.pdf. Accessed June 27, 2013
- . EMA-EFPIA Modelling and Simulation Workshop. BOS 3 Report—M&S as a tool to bridge efficacy and safety data in special populations. 30 Nov—1 Dec 2011, London. http://www.ema.europa.eu/docs/en_GB/documentJibrary/Report/2012/05/WC500127121.pdf. Accessed June 27, 2013
- . Lu JF, Bruno R, Eppler S, . Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol. 2008;62(5):779–786
- . Bruno R, Washington CB, Lu JF, . Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol. 2005;56(4):361–369
- . Berger M, Rojavin M, Kiessling P, . Pharmacokinetics of subcutaneous immunoglobulin and their use in dosing of replacement therapy in patients with primary immunodeficiencies. Clin Immunol. 2011;139(2):133–141
- . Wasserman RL, Melamed I, Kobrynski L, . Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAM-MAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol. 2011;31(3):323–331
- . Berger M, Jolies S, Orange JS, . Bioavailability of IgG administered by the subcutaneous route. J Clin Immunol. 2013;33(5):984–990
- . Gregory R, Malcolmson C, Patel C, . Experience with a 20% subcutaneous immunoglobulin (Hizentra®) in children with primary immunodeficiency diseases—a single-center review. J Allergy Clin Immunol. 2013;131(2):AB154
- . Malcolmson C, Gregory R, Patel C, . Patient satisfaction with 20% subcutaneous immunoglobulin (Hizentra®) treatment: results from a single-center study in children with immunodeficiencies. J Allergy Clin Immunol. 2013;131(2):AB155
- . Wasserman RL, Zidik J. Clinical utility of biweekly dosing with high-concentration subcutaneous immunoglobulin in patients with primary immunodeficiency: retrospective case series. Ann Allergy Asthma Immunol. 2013;111( Suppl 5):Oral abstract 31