Early Stage
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Eurofins ADME BIOANALYSES services span the complete drug development cycle for new chemical entities (NCE), biologics and generics.
Early Stage
It is in the early stages of development that reliable information is required with a quick response time and at a competitive price.
Eurofins ADME Bioanalyses offers a range of services in-house to aid in the decision making process from first “in-life” studies to compare products and formulations to in-vivo and in-vitro metabolism studies.
We have the capacity to manage studies on large, molecules, small molecules and ADC with all conventional and novel delivery systems.
Small molecule bioanalysis
- Any biological matrix (fluids and tissues)
- Supporting screening, pre-clinical exploratory/safety and clinical studies
- Small molecules (LC-MS/MS)
- Method development, transfer and/or optimization
- Fit for purpose method qualification & validation
- More than 1000 in-house validated methods
- GLP and GcLP compliant
Large molecule bioanalysis
- Diverse biological matrix (fluids and tissues)
- Supporting early, pre-clinical exploratory/safety and clinical studies
- Large molecules - ELISA / ECL (Mesoscale)
- Method development, transfer and/or optimization
- Fit for purpose method qualification & validation
- GLP and GcLP compliant
Topical product development
- IVRT/IVPT for generic product development
- In vitro / In vivo application of topical products
- Franz diffusion cells, Bronaugh diffusion cells, PhoenixTM Dry Heat system
- Skin distribution with radiolabelled (14C/3H) or cold compound
- Clinical dermal absorption, tape stripping, PK and Bioequivalence
- Bioanalytical method, development and validation for skin matrices
- Cosmetics, Pharmaceuticals, Safety Testing, formulations comparisons
- GLP compliant, OECD 428, SCCS guidelines
Screening studies
- Non-GLP, all phases in-house, adaptable study design for lead selection
- Exploratory PK blood-brain barrier, tissue distribution, CSF
- Calculation of Cmax, Tmax, AUC, t½ , Cl, Vd, Bioavailability (F%), tissue exposure etc.
- Different rodent species, single or cassette dosing, all administration routes
- Microsampling:PK profile on the same animal
- Only a small quantity of compound is required
- Standardised LC-MS/MS analytical development
- Rapid response: <2 weeks from agreement to study start
- Rapid turn-around: <2 weeks from reception of product to table of results
- Aggressive pricing policy to keep down development costs
