Method validation
Pre-clinical studies
Clinical Studies
METHOD VALIDATION
Since its establishment in 1987, ADME BIOANALYSES has developed, transferred and validated more than 200 analytical methods relating to animal and human biological fluid and tissues.
All method validations for unchanged drugs and metabolites are conducted in compliance with international requirements.
The validation could be partial or complete according to your need.
List of Bioanalytical methods validated.pdf
PRE-CLINICAL STUDIES
ADME
ADME studies are conducted to examine the absorption, distribution, metabolism, and excretion of new entities with either 14C and 3H molecules
- Balance of Excretion.
- Pulmonary Excretion.
- Blood and Plasma Kinetics.
- Biliary Excretion.
- Enterohepatic Recirculation.
- Tissue Distribution.
- Protein Binding.
ADME BIOANALYSES have experienced on many different administration routes in single or multiple dosing.
Toxicokinetics
Toxicokinetics studies measure animal exposure during toxicological studies:
- Assays method development and validation according to the May 2001 FDA guidance.
- Sample analysis.
- Toxicokinetic parameters calculations and interpretation using a fully validated softwares.
For such projects, we act either as study director or as principal investigator.
CLINICAL STUDIES
Clinical trials on healthy volunteers and patients are performed in close collaboration with recognized European Clinical Units. One of them is Eurofins Optimed Clinical Research Center
These include:
- Methodology and study design advice.
- Single and repeated dose.
- Fist administration in man.
- Dose ranging.
- Food effect.
- Drug interactions.
- Bioequivalence.
- Specific populations.
The samples collected during clinical trials (phases I, II, III) are analysed and pharmacokinetic parameters are calculated with a fully validated softwares.
