Optimization of Romiplostim Biosimilar Efficacy Trial Using In Silico Clinical Trial Approach for Patients With Immune Thrombocytopenia.

During biosimilar drug development, conducting a clinical trial of biosimilar efficacy in patients may become necessary in the presence of residual uncertainty regarding the biosimilarity of the drugs. In the development of the biosimilar romiplostim GP40141, we aimed to use a model-based in silico clinical trial (ISCT) approach to optimize the planned biosimilar efficacy trial in patients with immune thrombocytopenia. The population pharmacokinetic/pharmacodynamic model for healthy volunteers was modified and validated to describe platelet dynamics in patients with immune thrombocytopenia.

[Assessment of real myocardial energy demand using indirect calorimetry in early postoperative period after cardiac surgery].

Objective: To evaluate actual myocardial energy requirements using indirect calorimetry, oxygen delivery (DO), oxygen extraction ratio (OER), cardiac output (CO) and their components, as well as to study the impact of positive inotropic agent (dobutamine) on myocardial metabolism in early postoperative period after cardiac surgery.

Material And Methods: We measured the main metabolic parameters using indirect calorimetry in 20 patients after on-pump cardiac surgery with cardioplegia. To evaluate the impact of metabolic load on CO, VO and DO, we administered dobutamine 3 µg/kg/min at the second phase of the study.

Switchable 3D Photonic Crystals Based on the Insulator-to-Metal Transition in VO.

Photonic crystals (PhCs) are optical structures characterized by the spatial modulation of the dielectric function, which results in the formation of a photonic band gap (PBG) in the frequency spectrum. This PBG blocks the propagation of light, enabling filtering, confinement, and manipulation of light. Most of the research in this field has concentrated on static PhCs, which have fixed structural and material parameters, leading to a constant PBG.