Marika Kamberi
Santa Clara,USA
Title: Analytical Challenges in Method Development for Drug Eluting Stents Marika Kamberi PhD,
Biography
Biography: Marika Kamberi
Abstract
Drug eluting stents (DES) have become a standard of care for the treatment of symptomatic atherosclerotic coronary artery
disease. DES combine drug and device components, and are therefore combination products within the meaning of
section 503(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(g). Analytical methods used in drug eluting stents
analysis must be suffi ciently accurate, specifi c, sensitive and precise to ensure quality and reliability of the results, which in
turn are crucial for ensuring the quality, stability, safety and effi ciency of DES. Th ere are numerous challenges to overcome
when developing analytical methods for the DES products. Th e low levels of the active substance(s) loaded on the DES and
their poor water solubility, low levels of other analytes of interest (residual solvent, monomer content, lactic acid, oligomers,
and antioxidants) and the presence of polymer(s) in the sample matrix make the selection of sample pretreatment, detection
mode and the development of separation conditions extremely diffi cult. Limited guidance is available on how to achieve an
appropriate consideration of the analytical variability in analytical methods used to monitor the quality of the DES products
over the shelf-life and set the appropriate method validation acceptance criteria to maintain the method capability and
demonstrate its suitability for the intended purpose.