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薬理と治療
- Authors: Kumiko Miyata1, Kiyohiko Nakai1, Hidenobu Aso1, Haruki Kinoshita1, Takehiko Kawanishi1
Abstract
Background Epoetinβ is the recombinant human form of the mass−produced glycoproteinerythropoietin and is produced by Chugai Pharmaceutical Co., Ltd.(Tokyo, Japan)usingrecombinant technology. Recent advances in biotechnology have made it possible to manufacturebiologics without using animal by−products. This approach is assumed to be desirable,since it avoids unknown biorisks. Therefore, we changed to a new manufacturing processusing serum−free culture media without addition of animal by−products, and manufactured anew formulation of serum−free EPOCH(sf−EPOCH).Objectives The aim of this clinical trial was to confirm the comparability of the newEpoetinβ formulation sf−EPOCH, to the established EPOCH formulation and to confirm thesafety of sf−EPOCH.Methods Thirty two healthy adult male volunteers were divided randomly into two groups,and 6000 IU sf−EPOCH or EPOCH was given by subcutaneous administration. This studyincorporated a crossover design, where a 14−21 day washout period was inserted betweenthe first and second treatment periods. In pharmacokinetic analysis, bioequivalence wasassessed using Cmax, AUClast and MRT of serum erythropoietin, while pharmacodynamicanalysis comprised comparability assessment using reticulocyte counts.Results sf−EPOCH was determined to be bioequivalent and comparable to EPOCH. Inaddition, no safety difference was observed between sf−EPOCH and EPOCH.Conclusions As a result of this comparability study, sf−EPOCH, assumed to be desirablefrom the aspect of avoiding biorisks, was confirmed to be comparable to EPOCH used in currentclinical practice. It will be possible to use sf−EPOCH in clinical practice with the samedosage regimen as that currently used for EPOCH.(Jpn Pharmacol Ther 2009;37:95−107)KEY WORDS Comparability study, Bioequivalence study, Serum−free, Epoetinβ, Changein the manufacturing process of biotechnological/biological products
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