Bioanalytical methodologies plays an important role in the performance of toxicology studies conducted by RDDT. Our highly trained staff utilise an API 4000 Q Trap LC/MS/MS to develop quantitative, validated methods for traditional, small-molecule therapeutics, as well as novel biotechnology derived macromolecules. These methods are either developed de novo or implemented from existing procedure.
RDDT Bioanalytical Services include:
- GLP Bioanalytical Capability
- Method development
- Method validation
- Method transfer
- Pharmahokinetic / Toxicokinetic Analyses performed using Win Nonlin Pro Node 5.2™ software package (Pharsight Corporation, Mountain View, CA, USA).
RDDT Bioanalytical Services support the following investigations:
- Pharmacokinetic
- Nonclinical toxicokinetic (TK) studies
- Clinical pharnacokineic studies
- Drug-interaction studies
- Therapeutic drug monitoring studies
- Bioavailability
- Bioequivalence