Joan M Korth Bradley
Affiliation: Pfizer Global Research and Development
Korth Bradley J, Rendo P, Smith L, Altisent C. Pharmacokinetics, Efficacy, and Safety of Nonacog Alfa in Previously Treated Patients with Moderately Severe to Severe Hemophilia B. Clin Ther. 2016;38:936-44 pubmed publisher
..PK parameters are consistent with nonacog alfa use for FIX replacement in on-demand treatment, routine prophylaxis, and surgical prophylaxis in patients with hemophilia B. ..
Rudek M, Korth Bradley J. Don't Do Different Things…Do Things Differently! Drug Development in Rare Diseases. Clin Pharmacol Ther. 2016;100:333-5 pubmed publisher
..Regulatory guidances for rare diseases are available, as well as ones for specific rare diseases. Maintaining drug supply for rare diseases also demands innovative approaches. ..
Suzuki A, Tomono Y, Korth Bradley J. Population pharmacokinetic modelling of factor IX activity after administration of recombinant factor IX in patients with haemophilia B. Haemophilia. 2016;22:e359-66 pubmed publisher
..FIX is appropriately modelled as a two-compartment model after rFIX administration. When weight is included, no additional effect of age is observed. Longer times of observation after dosing may be helpful in refining the model. ..
Korth Bradley J, Parks V, Chalon S, Gourley I, Matschke K, Gossart S, et al
. Excretion of moxidectin into breast milk and pharmacokinetics in healthy lactating women. Antimicrob Agents Chemother. 2011;55:5200-4 pubmed publisher
..The most frequently reported adverse events were headache and nausea (n = 4), oropharyngeal pain (n = 2), rhinitis, viral pharyngitis, and viral upper respiratory tract infection (n = 2). ..
Hua B, Wu R, Sun F, Luo B, Alvey C, Labadie R, et al
. Confirmation of longer FIX activity half-life with prolonged sample collection after single doses of nonacog alfa in patients with haemophilia B. Thromb Haemost. 2017;117:1052-1057 pubmed publisher
..6 ± 5.5 h (truncated at 72 h) and 27.2 ± 7.0 h (truncated at 50 h). To accurately assess an adult patient's t½, sampling should be continued for at least 96 h. ..
Liu H, Wu R, Hu P, Sun F, Xu L, Liang Y, et al
. An Open-label, Single-dose, Pharmacokinetic Study of Factor VIII Activity After Administration of Moroctocog Alfa (AF-CC) in Male Chinese Patients With Hemophilia A. Clin Ther. 2017;39:1313-1319 pubmed publisher
..The single doses of moroctocog alfa (AF-CC) were well tolerated; 2 cases of transient, low-titer FVIII inhibitor development were observed. ClinicalTrials.gov identifier: NCT02461992. ..