Our Approach/Services
With a wealth of knowledge in the field of GLP bioanalysis, Tepnel Pharmaceutical Services offers a tailored bioanalytical testing service to meet your specific study requirements.
As an experienced provider of bioanalytical testing services, we pride ourself on developing and promoting a successful partnership with our sponsors so we become an extension of your facility. With every new bioanalysis project we undertake, the sponsor will be allocated a Project manager to facilitate your GLP bioanalysis requirements in a timely manner from start to finish.
Our comprehensive Bioanalysis and Bioanalytical Testing Services can support your Pre-Clinical and Clinical study requirements:
- Drug Substance Analysis
- Bioequivalence
- Animal Study Support
- Assay Development & Validation
- Custom ELISA
- PI-III human
- Pharmacokinetics
- DNA Extraction
- GLP Bioanalysis
- Genotyping
- Stability
Summarised below is what we believe to be key to building a successful relationship:
- Bioanalytical testing support for cell culture and single/cassette dosing studies
- Generic sample preparation/chromatography for early stage development
- Pharmacokinetic and Toxicokinetic studies
- Full method development, feasibility and validation covering NCEs, pre clinical and Phase I-III clinical trials
- Experience with complex matrices from all major species
- Where reliable and robust bioanalysis methods are in place we offer a rapid, quality assured method transfer service
- Study plans based on current regulatory guidelines
- Extensive range of pre-validated methods for generics
- Sample bioanalysis for a full range of mammalian species
- Clinical support from PI through to bioequivalence
- Large volume high throughput drug analysis capabilities
- Rapid turn around of data and Sample logistics and support
- Multi-purpose semi-automated liquid handling systems
- Long-term stability studies in matrix and solution analyte
- Identical system configuration permitting redundancy for critical assays
- Efficient delivery fo QA audited reports tailored to sponsors specification
- Preparation of expert reports including the PK statistical analysis
Non-proprietary assay portfolio
We have developed and validated more than 50 generic drug substances using the FDA and GLP guidelines of the time and successfully applied them to preclinical and clinical trials on a range of sample types. We have listed some of our key assays below. For a more comprehensive list of GLP bioanalysis assays please contact us at:
pharmaservices@gen-probe.com
| Alprazolam |
Lisinopril |
Clenbuterol |
| Fentanyl |
Ifenprodil |
Alfentanyl |
| Bromhexine |
Losartan |
Lansoprazol |
| Hydrochlorthiazide |
Morphine |
Morphine-3-glucuronide Morphine-6-glucuronide |
| Codeine |
Codeine6-glucuronide5-ASA |
Venlafaxine |
| Tramadolalproic acid |
Nifendipine |
Propranolol |
| Captopril |
Thiocyanate |
Phenytoin |
| Prednisolone |
Loratidine |
Midazolam |
Contact Us:
For further information on our GLP Bioanalysis and Bioanalytical Testing Services please contact:
Gen-Probe Life Sciences Ltd.
Tepnel Pharmaceutical Services
Appleton Place
Appleton Parkway
Livingston
West Lothian. EH54 7EZ
Tel: +44 (0)1506 424270
Email: pharmaservices@gen-probe.com
