Are you looking for bioanalytical/preclinical expertise for complex liposomal formulations?  

Eurofins Advinus has developed sensitive LC-MS/MS based bioanalytical methods for estimation of free, bound / encapsulated and total drug as per FDA and EMA compliance 
 

Choose Eurofins Advinus as your preferred service provider :

• To quantify free, bound and total drug levels in biological matrices post administration of liposomal formulations
• To carry out preclinical in vivo studies
• For tissue distribution data post IV administration of liposomal formulation from preclinical studies
• To determine free drug concentration at very low level
• For potassium leakage and in vitro free drug leakage studies

• Single dose comparative pharmacokinetics and tissue distribution study for liposomal doxorubicin formulation on fibrosarcoma tumor bearing mice
• LC-MS/MS based bioanalytical methods developed and validated for the determination of free doxorubicin, doxorubicinol, encapsulated and total doxorubicin in mice plasma
• Total doxorubicin and Doxorubicinol in mice heart, liver, spleen, skin and tumor
• We also offers comparative in vitro leakage study of Doxorubicin liposomal formulation by LC-MS
• Regulatory compliance – FDA and EMA

• In addition to all the above studies, we offer Comparative in vitro potassium leakage study from human / rat RBC

• Single dose comparative pharmacokinetics and tissue distribution study in SD rats for
  • Iron sucrose formulation
  • Ferric  carboxymaltose formulation
• ICP-MS based Bioanalytical methods developed and validated for determination of total and transferrin bound iron in rat serum
• Total iron estimation in the following rat matrices – RBC, Bone marrow, Liver, Heart, Lung, Kidney and Spleen

• We have developed a robust LC-MS method for simultaneous determination of Insulin Glargine and its active metabolite M1 and M2 in rat plasma
• The precision and accuracy of the developed method has been demonstrated, with sensitivity down to a lower level of 3.0 ng/mL with >5 S/N ratio, and linearity up to 120 ng/mL
• The method can be adapted for the analysis of human clinical samples