TK/PK試験・生物分析試験

TK/PK試験・生物分析試験

分析バリデーション、動物試験からTK・PK分析まで一貫して対応いたします。

各種特殊分析につきましても測定系の立ち上げから、測定のみの試験までお客様のニーズに合わせた試験デザイン・納期のご提案を行います。お気軽にお問い合わせください。

 

試験一覧

薬物分析

  • 投与液の濃度分析バリデーション試験
  • 投与液の濃度測定、安定性試験
  • 生体試料中の薬物濃度分析バリデーション試験
  • 生体試料中の薬物濃度分析
  • 原薬、製剤中の含量、類縁物質の分析法バリデーション試験
  • 原薬、製剤中の含量測定、安定性試験
  • 投与液の均一性、吸着性試験(含量測定)

生物分析

  • 抗体医薬品・タンパク製剤など、通常の機器分析では困難な被験物質の測定
    抗薬物抗体価の測定
  • サイトカイン・ケモカイン・酵素など、一般的な血液生化学検査では測定困難な生体内成分の測定
  • 食品中の特定保健用食品(トクホ)成分の測定
  • フローサイトメーター (FACS) を用いた血球成分の詳細な解析
  • 各動物種のミクロソームを用いたin vitroでの薬物代謝安定性の評価
  • 薬物の血清タンパク結合率の評価

技術情報

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