Our experienced scientists work closely with you to ensure appropriate bioanalytical techniques are used to maximize data generation and ensure your timelines are met.
We deliver rapid turnaround of PK and distribution studies, including both non-regulatory and regulatory (GLP) Toxicokinetics (TK) support.
Bioanalytical requirements are tailored to support studies depending on what data is required, such as limit of quantification, potential distribution into tissues, or a requirement for retrospective metabolite profiling (use of High-Resolution Accurate Mass).
If required, method feasibility studies can be performed quickly to provide an indication of how complex a bioanalytical method may need to be to support in vivo study. Alternatively, said feasibility study can help drive the in vivo design to ensure all necessary data can be collected without bioanalytical limitations.
Common microsampling techniques such as dried blood spots (DBS), capillary microsampling (CMS), Volumetric Adsorptive Microsampling (VAMS) and blood/water can be supported if required if part of in vivo study design. WinNonLin is used to determine PK parameters in all studies.
A single point of contact directs clients through the study and all elements are performed to the highest quality to assure our clients of data integrity.
Our services
Discovery bioanalytical services
- Rapid PK studies
- ‘Cold’ Tissue Distribution support
- Method Feasibility if required
- Application of High-Resolution Accurate Mass technology for retrospective data mining.
- PK data analysis (WinNonlin) available
- Microsampling techniques (DBS, CMS, VAMS and Blood/Water) fully supported
GLP bioanalytical services
- LC-MS/MS Method Feasibility and Development
- LC-MS/MS Method Validation in accordance with current industry guidelines and to GLP when required
- Full support for all pre-clinical studies in all species
- TK data analysis (WinNonlin) available
- Microsampling techniques (DBS, CMS, VAMS and Blood/Water) fully supported
We continue to work closely with you to ensure a smooth transition from rapid, discovery PK support through non-regulatory preclinical TK assessments (such as dose range finding and maximum tolerated dose studies) into formal GLP bioanalysis that underpins TK safety assessments.
Bioanalytical requirements are tailored to support studies depending on their position in either discovery or development. If required, method feasibility studies can be performed quickly to provide an indication of how complex method development may be.
Methods are then developed and if necessary validated to an appropriate level. This ranges from scientific validations that are suitable for early-stage non-regulatory studies (such as MTD and DRF), through to full regulatory validations required to support TK safety studies. Current industry guidelines are followed, and all regulatory work is performed in accordance with GLP.
A single Concept Life Sciences point of contact directs you through the various studies within a project (method development to sample analysis) and all elements of the project are performed to the highest quality to ensure data integrity.
Each study is performed in accordance with a plan and is documented clearly for ease of any inspection. We provide standardized and tailored formal reports for method validation studies and sample analysis projects. TK data analysis can be performed if required.
Concept Life Sciences prides itself on high quality, transparency, and data integrity, assuring the compliance of regulatory submissions for our clients.