Combination Medical Device Drug Development Contract Services
Whether you are developing a drug eluting Stent, Balloon, Catheter, Patch, Biologic Matrix or other drug eluting or drug coated combination medical device, we can help. BASi®'s analytical groups have extensive experience determining drug levels associated with combination medical devices.
Maintaining a superior quality record has always been foremost for BASi®, and auditors are quick to compliment the processes we have implemented. We are responsive to client's specific needs; flexibility is key. We take extra effort to respond quickly to all inquiries and to complete studies on time, every time. BASi®'s leadership and partnership with clients around the world has helped successfully bring numerous combination products to market.
Medical Device Bioanalytical Services
- GLP compliant analysis of preclinical and clinical study tissues, blood, plasma and urine samples using LC-MS/MS
- Extensive validated assay list of compounds commonly applied to drug coated medical devices
- Development and validation of bioanalytical methods for novel API / matrices
Medical Device Pharmaceutical Analysis Services
- Product testing including drug concentration, uniformity and other physical tests (cGMP)
- Explant determinations of residual device drug concentrations (GLP)
- Early stage drug Method Development and GMP Validation thru Post-commercialization Product Testing
- Device stability storage (ICH conditions) and testing (cGMP)
Validated Combination Medical Device Bioanalytical Assays and Matrices*
| Drugs | --------- Matrices --------- | Species | |
| Dexamethasone | Adipose | Lung | Dog |
| Donepezil | Arterial Wall | Muscle | Human |
| Everolimus | Coronary Artery & Vein | Myocardium | Mouse |
| Minocycline | CSF | Plasma | Pig |
| Paclitaxel | Dura | Serum | Rabbit |
| Rapamycin (Sirolimus) | Endocardium | Skin | Rat |
| Rifampin | Kidney | Spleen | |
| Tacrolimus | Liver | Whole Blood | |
* Validated assays not currently available for all drug/matrix/species combinations. Others can be validated upon request. Ask your BASi® representative or contact BASi for details. View the publicly available BASi® Assay List.
Pharmaceutical Analysis Combination Medical Device Assays
As big as the USP, and then some!
Other BASi® Services
- Preclinical Pharmaceutical Toxicology
- PK/TK, Acute, Sub-chronic, Chronic, Carcinogenicity Studies
- Mice, Rats, Swine, Dogs, Monkeys, Rabbits (Ask about additional species)
- AAALAC, NIH DEA, USDA, FDA Credentials
- In Vivo PK sampling using BASi® patented BASi Culex ® minimal stress automated technology
- GLP and Non-GLP studies
