Our services for in vivo DMPK research
Our in vivo drug metabolism and pharmacokinetic (DMPK) services cover a complete range of different animal studies in several species. The in vivo DMPK services are available for all drug modalities, e.g., small molecules, peptides, oligonucleotides, antibodies and ADCs.
We have AAALAC-accredited in-house animal facilities housing mice and rats, and studies with other species are performed together with chosen European in-life partners. The partner for each study is chosen based on the study requirements (animal species, sample type, radiolabeled vs non-labeled compound). We manage the whole process for you; from study planning to bioanalytical tasks (LC/MS/MS, LC/HR-MS, LC/radiodetection), pharmacokinetic evaluation and reporting.
Samples for bioanalytics and pharmacokinetic evaluation from animal work performed by the customer or other in-life-site are also accepted. These studies often include identification of circulating or excreted metabolites, analyzing known biomarkers, as well as evaluation of metabolites’ pharmacokinetics with respect to the parent drug or multispecies metabolite profiling.
From a drug safety perspective, we offer correlation of metabolite exposure between human and preclinical species and thus identification of metabolites disproportionate or unique in human. This can be done by comparing the in vivo metabolite profiles from animal species to in vitro human models and characterizing in vivo human metabolites from FIM, SAD, MAD or human ADME studies with cold or radiolabeled compounds against the preclinical animal samples. More detailed description of this service can be found on our Safety Metabolism page.
- In-house AAALAC accredited animal facilities to house mice and rats
- Studies with other species are conducted with AAALAC accredited/GLP partner companies
- Single or repeated dosing (i.p., i.v., p.o., s.c., i.m.)
- Single compound or cassette dosing
- Studies with small molecules, peptides and proteins
- Plasma sampling, tissue and CSF collection
- Metabolic cages
- Metabolite identification and profiling
- Bioanalysis by LC/MS/MS or UPLC/High-resolution-MS analysis
- On-line and off-line radiodetection
- Full pharmacokinetic evaluation using Phoenix® WinNonlin®
In in vivo DMPK studies, compounds are administered to rodents and samples collected over a pre-defined time period. The dosing regimen and sampling are designed according to the project needs and prior information available on the study compounds, and the concentration-time data can be summarized using non-compartmental analysis (NCA) or compartmental modelling. Several options are available for bioanalytics, and the methods are always optimized for the study compounds instead of using generic methods. Furthermore, when LC/HR-MS is used, the same data can be used later for metabolite identification and profiling.
The experiments can be designed e.g., for initial PK screening of multiple compounds, in vivo BBB permeability or for more advanced PK profiling. Metabolic cages are available for investigating the excretion of the compound to urine and feces. Also radiolabeled compounds can be used. Reach out to us to discuss how we could help you.