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PK-PD – Metabolism

PK-PD – Metabolism

To support preclinical and clinical development programs, ERBC conducts PK-PD and metabolism studies on pharmaceuticals and biotechnology based products.

Conducted in a broad range of administration routes, dosing regimens and animal species, these studies are managed by senior scientists with deep expertise in biology, pharmacology, data analytics and regulatory.

Pharmacokinetic – bioavailability

  • Species: rat, mouse, rabbit, dog, minipig, marmoset
  • All administration routes
  • Analysis of biological samples (plasma, urine, tissues…)

Pharmacodynamic in vivo and in vitro

  • Deep expertise in human recombinant proteins, notably GSCF, hGH and EPO (in vivo)

In vitro metabolism

  • Evaluation of metabolism using liver metabolic fractions (S9, microsomes)
  • Evaluation of metabolism using hepatocytes
  • Metabolite profiling, identification and quantification
  • CYP phenotyping assay
  • CYP induction in human hepatocytes
  • CYP inhibition in human liver microsomes
  • Time dependent CYP inhibition in human liver microsomes

Skin Penetration Study

  • In vitro Skin Absorption (OECD 428) 

Histochemical and immunohistochemical determinations in tissues

  • Cytochrome p450
  • Glutathion S-transferase
  • γ-Glutamyl transpeptidase
  • Cytochrome oxidase
  • Adenosine triphosphatase
  • Glucose-6-phosphate dehydrogenase