iC42 provides a complete range of innovative capabilities to support the development of drug eluting stents including quantification of drugs, their metabolites and degradation products in blood, tissues and on stents.
iC42 has more than 15 years of experience in the development of drug eluting stents and provides a complete range of innovative capabilities to support their development:
- Quantification of drugs, their metabolites and degradation products in blood, tissues and on stents
- Drug stability testing in forced degradation studies and on stents (production process and aging) following ICH guidelines
- Structural identification of drug degradation products
- Matrix degradation profiling
- Elution testing from stents
- Lot release testing
- Drug development for new drugs including:
a. Drug metabolism studies including structural identification and activity testing of drug metabolites
b. Drug distribution studies
c. Drug-drug interaction studies
d. Animal toxicology
e. Phase I clinical trials (single ascending and multiple ascending dose studies)
f. Bioanalysis and pharmacokinetic analysis for clinical trials after stent implantation
- Consulting, interactions with regulatory agencies and strategy development
iC42 has extensive experience in the development and validation of LC/LC-MS/MS assays with ultra-high sensitivity for the quantification of drugs eluted from stents in a cGLP/ CAP-accredited environment. Depending on the drug, assays with lower limits of quantitation of less than 10 pg/mL in whole blood and lower limits of detection of less than 1 pg/mL have been developed and successfully been utilized for clinical trials.
For more background information on drug eluting stents, please click here to learn more.