Journal of Bioequivalence & Bioavailability

Sakuo Hoshi

Publications

• Research Article
  The Influence of Formula Concentration on the Absorption of Darbepoetin Alfa after Subcutaneous Administration
  Author(s): Tomonori Tayama, Kazuki Kawakami, Hirotaka Takama, Daisuke Nakashima, Hideji Tanaka, Takayuki Tsuji, Tatsuo Yamamoto, Sakuo Hoshi and Tadao AkizawaTomonori Tayama, Kazuki Kawakami, Hirotaka Takama, Daisuke Nakashima, Hideji Tanaka, Takayuki Tsuji, Tatsuo Yamamoto, Sakuo Hoshi and Tadao Akizawa
  
  Darbepoetin alfa (DA) is a hyperglycosylated analog of recombinant human erythropoietin (rHuEPO) that stim u- lates red blood cell production. The aim of this st udy is to investigate the influence of formula concentration on the absorption of DA after subcutaneous administration. Three separate studies were performed to assess the bioequivalence of four different formula concentrat ions of DA, 100 μ g/ml as reference concentration, comparing with 10, 30, 200 μ g/ml as test concentration, by the same dosage (60 μ g). The mean values of the pharmacokinetic parameters were similar after subcutaneous administ ra- tion in each study. The 90% confidence intervals fo r log- transformed C max and AUC 0 -t were within the bioequivalence criteria (0.8-1.25) in each study. I n previ- ous studies, the effect in absorption process of in sulin was correlated to the formula concentra.. View More»
  DOI: 10.4172/jbb.1000021

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