Toxicokinetics/Pharmacokinetics (TK/PK) measures drug concentrations in body fluids during clinical trials (Phases I to III), except viral or DNA vaccines or Gene Therapy (see Biodistribution section). Texcell offers validation of TK/PK assays according to the bioanalytical validation guidelines (ICHQ2(R1), EMA, FDA).

Sample testing is performed under GLP or GCLP (including multisite GLP).

Main Guidelines:

  • ICH S3A: Note for Guidance on Toxicokinetics: the Assessment of Systemic Exposure in Toxicity Studies
  • ICH S6(R1) Addendum and ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
  • EMA (2007). “Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins” EMEA/CHMP/EWP/89249/2004.

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