Pharmacokinetic analysis and ADME


At Biotest Facility we offer service in planning and conducting initial animal tests, including toxicity testing, pharmacokinetic (PK), biodistribution, and metabolism (ADME). Our services cover a range of solutions, from small standard studies to large collaborative research projects. We aspire to remain cost-effective, and to adhere to the 3R principles.

The studies are planned with careful inclusion of in vitro results and other available information, to mimic intended therapy in efficacy models and humans. Several points are discussed in advance of the study, namely the quality of the drug product, the formulation of drug for in vivo testing, administration routes and doses, treatment groups and group sizes, time point for dosing and sampling, monitoring of animals, and bioanalyses of samples, results, and statistics.


At Biotest Facility we formulate and administer a wide range of drug classes; from small chemical entities to large biologics, and hazardous drug classes such as radiotherapeutics and cytotoxic anti-cancer agents. Compatibility with in vivo administration is ensured and quality of formulation is analysed.


The administration routes selected for a PK-study are the intended RoA for therapy in humans, combined with RoA that contribute to the investigation of the in vivo availability of the drug product; intravenous administration is combined with peroral administered drug product to gain information about bioavailability. Various RoA and administration techniques are available, e.g. peroral, intravenous, topical, subcutaneous, intranasal, intrapulmonary, intrarectal, or intramuscular. In accordance with a specific rationale, special routes such as intratumoral and intraduodenal administration can be applied.


The study parameters such as RoA, sampling time points, sample volume, bioanalyses, and statistics, all affect study design, including group sizes and number of groups in the study. Advancements such as microsampling techniques and increased sensitivity of bioanalytical techniques contribute to refinement and reduction of the number of animals needed in the study. Biotest Facility supports most sampling techniques for collecting blood, urine, faeces, and tissues for PK and ADME / Mass Balance analyses.


Biotest Facility offers various levels of analytic services, such as in-house services or work carried out in collaborations with trusted technical partners. Simple PK data analyses to determine elimination rates and bioavailability, e.g. non-compartmental modelling, is typically conducted in-house. Advanced mathematical simulations and analyses of ADME data is conducted in close collaboration with our skilled partners.


Biotest Facility is an independent privately held CRO that services pharma and biotech companies, as well as academic institutions. Pharmacokinetic studies are taken on as short lead-up tasks, and we maintain a constant high readiness when it comes to these.

Visualisation of typical data from a pharmacokinetic dosing experiment.
Example of a typical pharmacokinetics graph. A PK-study will give information about the elimination half-life (t½), volume of distribution (Vd), and peak plasma concentration (Cmax), for a test substance, along with a range of other valuable metrics.