Pharmacokinetic (PK) studies
Pharmacokinetics is the quantitative analysis of the metabolic processes of drug absorption, distribution, metabolism and excretion (ADME). In early preclinical development, PK studies provide essential data for determining a dosing schedule and the route of administration for in vivo efficacy testing.
EPO offers a broad variety of possible study designs to evaluate the pharmacological performance of new drug formulations. These include:
- Pharmacokinetics after single bolus or repeated application. Availability of several different application routes.
- Sampling of organs or blood with optional processing to serum or plasma for bioanalytical testing
- Bioanalysis of the samples with methods such LC-MS/MS for the detection of small molecules in collaboration with partner companies. ELISA for the detection of antibodies (in-house).
Toxicity testing including MTD (Maximum-Tolerated Dose) determination
The primary purpose of early in vivo preclinical toxicity testing of drug candidates is to assess if a compound is safe for use and to determine the highest dose (Maximum-Tolerated Dose; MTD) that promises the best antitumor efficacy but does not trigger any severe side effects.
EPO provides comprehensive guidance in the design of such studies based on the 3R principle and offers a broad variety of possible study designs, including:
- Evaluation of tolerability (body weights, health scoring, daily monitoring)
- Dose escalation studies to determine the Maximum-Tolerated Dose (MTD) and the No-observed-effect level (NOEL)
- Blood biochemistry and hematology (in collaboration with an external partner)
- Necropsy and histopathological evaluation of tissues (in-house)
- Specialized study designs such as bone marrow toxicology