OUR STUDIES SUPPORT ALL PHASES OF DEVELOPMENT
When ADME properties of a drug candidate are being investigated, we look for the following information:
- Absorption (rate and extent)
- Distribution (time course and sites of distribution in organs, tissues and body fluids, with special emphasis on accumulation)
- Metabolism (rate of metabolism, metabolic pathways, tentative metabolite identification, assessment of potential pharmacological activity or toxic effect)
- Elimination (rate and routes of elimination)
The results of the above investigations form a significant part of regulatory submissions. The data obtained allow us to estimate the overall and local drug exposure of the active substance, interpret the presence, the onset and persistence of pharmacological or toxic effects.
The studies are performed in compliance with the current guidelines (FDA, EMA, ICH and OECD) and in accordance with GLP regulations if requested.
In vivo experiments can be performed in the required rodent and non-rodent species. The route of administration can be selected as requested (incl. transdermal, osmotic minipump).
Our studies can support all phases of development through:
- pharmacokinetics, bioavailability studies in rodent and non-rodent species and in humans
- tissue distribution, protein-binding and excretion balance studies
- toxicokinetics in toxicity studies and safety pharmacology
- In vitro and in vivo metabolism studies, with proﬁling and metabolite identiﬁcation
- biopharmaceutical assessment (pre-formulation and formulation studies).
The bioanalysis is performed using a wide range of analytical platforms:
- LC-MS/MS, ELISA, flow-cytometry, Luminex
- Metabolite identiﬁcation (triple quad, ion-trap)
Study results are evaluated by experts:
- Pharmacokinetics, toxicokinetics with an acknowledged and validated tool (WinNonLin)
- First-in-man dose prediction
- Dosimetery calculation for human metabolism studies
For further information please feel free to start a conversation.