We can support your discovery in vitro metabolism with the following studies
In-vitro clearance in microsomes, hepatocytes
Early X species in-vitro metabolism investigations, soft spot analysis
Plasma protein binding and whole blood distribution
CYP inhibition
Permeability in Caco-2 cells
Metabolite profiling and identification (MetID) across species (microsomes, hepatocytes, S9 fractions) using radiolabeled or unlabeled (cold) material
MET ID in rodent/non-rodent species and humans (clinical samples)
Quantitative estimation of human metabolites,
Relative exposure to human metabolites, MiST assessment
hAME (human mass balance), formulation and in life by partner CRO
Plasma protein binding & identification of binding partners
Whole blood distribution (blood/plasma ratio)
Hepatocyte uptake
Intrinsic clearance (microsomes, hepatocytes, S9 fraction)
Cytochrome P450 (CYP) inhibition
CYP induction
CYP and non-CYP reaction phenotyping
ABC-transporter substrate in Caco-2 (P-gp and BCRP)
ABC-transporter inhibition in Caco-2 (P-gp and BCRP)
SLC-transporter substrate in HEK cells (OATP1B1/3, OAT1/3, OCT1/2, MATE1/2-K) by partner CRO
SLC-transporter inhibitor in HEK cells (OATP1B1/3, OAT1/3, OCT1/2, MATE1/2-K) by partner CRO
Support with candidate selection and human PK and (first) dose predictions
DMPK data evaluation and integration, gap analyses
Evaluation of drug-drug interaction potential
Writing of DMPK sections in essential documentation, such as IND, IMPD, and IB
All studies will be performed in compliance with FDA and EMA requirements as described in the respective guidelines.
Over 400 In-vitro PK and In-vivo ADME Studies, including met ID completed since 2016
Top-notch equipment and technologies for quantitative bioanalysis, metabolite profiling and structure elucidation
Big and mid-size pharmaceutical companies, biotech companies and universities
Our experts guide pharmaceutical clients throughout all R&D phases starting from discovery into clinical development and marketing authorization.
In helping you to generate PK data to enable the safe administration of NCEs at the right dose and regimen to maximize the benefit for patients
Standardized or tailor-made high quality DMPK studies and complete packages enabling IND/ IMPD, start of first in human and/ or large clinical trials
