Safety evaluation of biotechnology-derived pharmaceuticals

バイオ医薬品では，薬理作用に種特異性が高い場合が多く，安全性評価には薬理作用が認められる動物種を用いることが望まれる．毒性の特徴として，医薬品自体に対する免疫反応の誘導，抗体医薬の一部に認められるサイトカイン放出などがあり，ヒト細胞を用いたin vitro評価法などが検討されている．DDSによるバイオ医薬品の毒性への影響の例として，PEG化による免疫原性の改善，PEG化リポソームにおけるABC現象，徐放性製剤における皮膚刺激性について解説する．

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