Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US-licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE-3 (Recombinant Human INsulin Equivalence-3) study.

AIM: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30; Eli Lilly and Company, IN). MATERIALS AND METHODS: In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin-70/30 and HUMULIN-70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 24 hours - AUCins.0-24h - and maximum insulin concentration - Cins.max . Primary PD endpoints were area under the GIR time curve from 0 to 24 hours - AUCGIR.0-24h - and maximum GIR - GIRmax . RESULTS: Equivalence was shown between Biocon's Insulin-70/30 and HUMULIN-70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%-125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported. CONCLUSION: PK/PD equivalence was demonstrated between Biocon's Insulin-70/30 and HUMULIN-70/30 in healthy subjects. Treatment with Biocon's Insulin-70/30 and HUMULIN-70/30 was well tolerated.

Functionalised Graphene Quantum Dots for Cholesterol Detection in Human Blood Serum.

The varied applications of nanotechnology have paved way for several breakthroughs in the realm of biomedical technology. In this challenging era when illness multiplies, timely and accurate disease diagnosis is very important. Thus, well founded novel approaches matter very much in areas like disease diagnosis and monitoring. Nanomedicine has tremendous implications in the given context. An elevated cholesterol concentration in blood is risky and is associated with cardiovascular diseases (CVD). CVD remains the No. 1 global cause of death and hence there is an urge to understand cholesterol level and take preventive measures. Highly fluorescent graphene quantum dots (GQs) are well known for their biocompatibility, non toxicity and aqueous solubility. Here in we report an easy and sensitive non enzymatic based cholesterol detection using digitonin conjugated graphene quantum dots (GDG). Selectivity studies and the cholesterol detection in human blood serum suggests the probe to be reliable and selective for blood cholesterol monitoring. Digitonin conjugated fluorescent graphene quantumdots, an efficient probe for cholesterol sensing.