Nuvisan DMPK services

Our laboratory in Grafing, Germany is a long-established center of excellence in regulatory drug metabolism and pharmacokinetics (DMPK) testing and consultancy. With over 50 years of continuous DMPK expertise, our experienced team delivers a comprehensive range of regulatory in vitro and in vivo studies. We are committed to scientific rigor, customized solutions and expert guidance to support our clients’ development strategies.

Complete DMPK workflows. One Location.

In vitro ADME In vivo ADME Drug–drug interaction studies Isotope chemistry DMPK consultancy

Leverage our expertise to simplify your DMPK journey 

Full ADME/DMPK support – from discovery through IND-enabling studies 
Single point of contact - eliminate the need to manage multiple CROs 
Direct access to scientists – speak directly with the experts running your studies. 
Regulatory-compliant – studies designed to meet guideline requirements, such as ICH M12 to ensure IND acceptance 
Tailored designs – customized studies based on your compound’s unique characteristics, not one-size-fits-all 
Project-focused execution – rooted in big pharma heritage, offering understanding of your overall project needs and help delivering on your full development milestones, not just individual assays.

In vitro ADME

In vitro ADME/DMPK assays are critical for the characterisation of a compound’s pharmacokinetic profile. These studies enable essential insights into absorption, distribution, metabolism and elimination properties, helping you anticipate clinical behavior and support successful IND submissions and downstream drug development. 

Core in vitro ADME/DMPK assay portfolio: 

Permeability and transporter (P-gp, BCRP) phenotyping in Caco-2 cells  
Plasma protein binding 
Plasma protein identification (binding partners) 
Tissue (e.g., brain) binding 
Whole blood distribution (blood/plasma ratio)  
Intrinsic clearance (microsomes, hepatocytes and S9 fractions) 
Interspecies comparison/metabolite identification (MetID) - unlabeled, 14C-, or 3H-labeled test item 
Covalent binding (14C- or 3H-labeled test item).

In vivo ADME

In vivo ADME/DMPK studies are essential to provide quantitative, system-level pharmacokinetic data that translate in vitro findings, support human PK prediction, guide dose selection, and enable regulatory submissions to health authorities (IND/IMPD).

Key in vivo ADME/DMPK studies with radiolabeled or unlabeled drug candidates comprise: 

Pharmacokinetics (PK) in rodent and dogs (basic PK parameters, bioavailability and tissue/plasma ratios) 
Mass balance including biliary excretion and investigation of volatile radioactivity 
Metabolite profiling and identification in rodents, dogs and humans (plasma, urine, feces, bile and tissues) 
Relative exposure of metabolites (human vs. toxicology species; mixed-matrix approach) 
 Quantitative estimation of human metabolites using samples from first-in-human trials and radioactive calibrator 
Tissue distribution by quantitative whole-body autoradiography (QWBA) 
Placental transfer and exposure in fetus 
Investigation of melanin binding.

Drug–drug interaction (DDI) studies

Drug–drug interaction (DDI) studies are a critical component of development, assessing the potential for a drug candidate to affect or be affected by concomitant medications. These studies help to predict clinical interactions and inform labelling. They are required by regulatory agencies such as the EMA and FDA to help ensure patient safety and therapeutic efficacy.

CYP inhibition (direct, time- and metabolism-dependent) 
UGT inhibition 
CYP induction (mRNA and enzyme activity-based) 
CYP and non-CYP (e.g., UGT) phenotyping (identifying drug metabolizing enzymes) 
ABC and SLC transporter inhibition (e.g., P-gp, BCRP, OATP, OAT, OCT and MATE) 
ABC and SLC transporter phenotyping (e.g., P-gp, BCRP, OATP, OAT, OCT and MATE) 
DDI risk assessment using basic and mechanistic static models.ch

Isotope chemistry

Radiolabeling enables precise tracking of drug-related material in biological systems, making it indispensable for definitive ADME characterisation. Performing radiosynthesis and downstream studies all at one site helps ensure compound integrity, reduce logistical complexity and accelerate timelines, all of which offer critical advantages in regulated environments.

Our isotope chemistry capabilities include: 

14C- and 3H-radiosynthesis 
Stable isotope labeling (e.g., 2H, 13C, 15N) 
Analysis and re-purification 
Stability investigations of radiolabeled compounds and drug formulations 
Manufacturing and characterisation of radioactive lipid nanoparticle (LNP) formulations 
Storage of radiolabeled compounds and world-wide shipment.

Studies benefiting from on-site radiolabeling include:

Mass balance studies 
Quantitative whole-body autoradiography (QWBA) 
Metabolite profiling and identification 
Covalent binding.

We are very happy to have your support always at the highest professional level. […] Your comprehensive analysis of the available data, coupled with your insightful recommendations, have been extremely valuable. I deeply appreciate the effort and attention to detail you put into preparing for our discussion. As always, your expertise has helped us better understand compound-related concerns, and we received good advice on what to do next.

Head of DMPK – Associate Director

Molecure SA, Poland

DMPK consultancy

Expert DMPK consultancy offers strategic value across all stages of drug R&D. From early study planning to regulatory submission, experienced DMPK scientists help design efficient, compliant programs tailored to each compound’s profile.

Strategic study planning from discovery to development 
Data review, evaluation and integration 
Support of drug candidate selection 
Human PK prediction (e.g., allometric scaling, IVIVE) 
Human dose prediction 
Evaluation of drug-drug interaction risks (DDI) 
Due diligence 
Gap analysis 
Support of clinical trial design 
Scientific writing: DMPK sections of briefing book, IND, IMPD, IB 
Centralized project management and coordination 
Independent DMPK representation as an extra scientific perspective.