Non-Clinical

IN VITRO PK & BIOTRANSFORMATION

Supporting Pharmaceutical Clients with
DMPK Studies and scientific Consultancy
along the entire R&D Value Chain

In vitro studies during discovery

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

In vitro studies during development


Absorption

Permeability in Caco-2 cells

Biotransformation

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

Distribution

Plasma protein binding & identification of binding partners

Whole blood distribution (blood/plasma ratio)

Hepatocyte uptake

Metabolism

Intrinsic clearance (microsomes, hepatocytes, S9 fraction)

Cytochrome P450 (CYP) inhibition

CYP induction

CYP and non-CYP reaction phenotyping

Transporter phenotyping and inhibition

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

DMPK consultancy

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

Quality

All studies will be performed in compliance with FDA and EMA requirements as described in the respective guidelines.

WHY WORKING WITH NUVISAN?

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

OUR CLIENTS IN THIS SECTION

Big and mid-size pharmaceutical companies, biotech companies and universities

Summary

Our experts guide pharmaceutical clients throughout all R&D phases starting from discovery into clinical development and marketing authorization.

Our Mission:

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

CORRESPONDING SITES

Grafing / Germany