This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1(GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight lossachieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabe-tes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinicalguidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients.

Purpose: Hepatitis B is a major prognostic factor after hematopoietic stem cell transplantation (HSCT). Currently, no consensus exists regarding the management of various scenarios that can lead to reverse seroconversion of the hepatitis B surface antigen (HBsAg-RS). This study focused on HBsAg-RS, which serves as an indicator of active hepatitis, and aimed to obtain exploratory information on the associated patient and treatment factors. Methods: This single-center retrospective study utilized clinical data extracted from the electronic medical records of Seoul St. Mary’s Hospital, Korea. Patients who underwent HSCT between January 2013 and December 2018 and tested negative for hepatitis B surface antigen (HBsAg) before undergoing HSCT were included. The associations between HBsAg-RS and demographic information, baseline hepatitis B serological markers, and vaccination status were statistically analyzed. Results: This study included 1,344 patients, of whom 83.3% tested positive for the hepatitis B surface antibody (HBsAb) during HSCT. HBsAg-RS occurred in 2.2% of HBsAb-negative patients and 3.0% of HBsAb-positive patients, indicating no significant difference in reactivation rates according to HBsAb status. However, positivity for hepatitis B core antibody (HBcAb) was significantly associated with hepatitis B reactivation (HBsAg-RS rate: 8.0%). The vaccination rates were highest in patients who were negative for both HBsAb and HBcAb and had a transient protective effect. Conclusion The sufficient patient population enabled the identification of an association between baseline HBcAb positivity and the development of HBsAg-RS. Further prospective studies are warranted to determine optimal vac‑ cination strategies for preventing HBsAg-RS.

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1(GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight lossachieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabe-tes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinicalguidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients.

Purpose: Hepatitis B is a major prognostic factor after hematopoietic stem cell transplantation (HSCT). Currently, no consensus exists regarding the management of various scenarios that can lead to reverse seroconversion of the hepatitis B surface antigen (HBsAg-RS). This study focused on HBsAg-RS, which serves as an indicator of active hepatitis, and aimed to obtain exploratory information on the associated patient and treatment factors. Methods: This single-center retrospective study utilized clinical data extracted from the electronic medical records of Seoul St. Mary’s Hospital, Korea. Patients who underwent HSCT between January 2013 and December 2018 and tested negative for hepatitis B surface antigen (HBsAg) before undergoing HSCT were included. The associations between HBsAg-RS and demographic information, baseline hepatitis B serological markers, and vaccination status were statistically analyzed. Results: This study included 1,344 patients, of whom 83.3% tested positive for the hepatitis B surface antibody (HBsAb) during HSCT. HBsAg-RS occurred in 2.2% of HBsAb-negative patients and 3.0% of HBsAb-positive patients, indicating no significant difference in reactivation rates according to HBsAb status. However, positivity for hepatitis B core antibody (HBcAb) was significantly associated with hepatitis B reactivation (HBsAg-RS rate: 8.0%). The vaccination rates were highest in patients who were negative for both HBsAb and HBcAb and had a transient protective effect. Conclusion The sufficient patient population enabled the identification of an association between baseline HBcAb positivity and the development of HBsAg-RS. Further prospective studies are warranted to determine optimal vac‑ cination strategies for preventing HBsAg-RS.

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1(GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight lossachieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabe-tes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinicalguidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients.

Purpose: Hepatitis B is a major prognostic factor after hematopoietic stem cell transplantation (HSCT). Currently, no consensus exists regarding the management of various scenarios that can lead to reverse seroconversion of the hepatitis B surface antigen (HBsAg-RS). This study focused on HBsAg-RS, which serves as an indicator of active hepatitis, and aimed to obtain exploratory information on the associated patient and treatment factors. Methods: This single-center retrospective study utilized clinical data extracted from the electronic medical records of Seoul St. Mary’s Hospital, Korea. Patients who underwent HSCT between January 2013 and December 2018 and tested negative for hepatitis B surface antigen (HBsAg) before undergoing HSCT were included. The associations between HBsAg-RS and demographic information, baseline hepatitis B serological markers, and vaccination status were statistically analyzed. Results: This study included 1,344 patients, of whom 83.3% tested positive for the hepatitis B surface antibody (HBsAb) during HSCT. HBsAg-RS occurred in 2.2% of HBsAb-negative patients and 3.0% of HBsAb-positive patients, indicating no significant difference in reactivation rates according to HBsAb status. However, positivity for hepatitis B core antibody (HBcAb) was significantly associated with hepatitis B reactivation (HBsAg-RS rate: 8.0%). The vaccination rates were highest in patients who were negative for both HBsAb and HBcAb and had a transient protective effect. Conclusion The sufficient patient population enabled the identification of an association between baseline HBcAb positivity and the development of HBsAg-RS. Further prospective studies are warranted to determine optimal vac‑ cination strategies for preventing HBsAg-RS.

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1(GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight lossachieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabe-tes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinicalguidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients.

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

A new sustained-release (SR) pregabalin tablet, YHD1119, was formulated for once-daily dosing. In the current study, we aimed to evaluate the pharmacokinetics of YHD1119 tablets in patients with reduced renal function. Subjects were grouped by creatinine clearance:> 60 mL/min/1.73m 2 (Cohort A) and 30–60 mL/min/1.73m 2 (Cohort B). Eight subjects in Cohort A received a YHD1119 75 mg tablet (Y75T) and a YHD1119 150 mg tablet (Y150T) in each period, and eight subjects in Cohort B received a Y75T. Non-compartment analysis and population pharmacokinetic analysis using a one-compartment model with first-order elimination and first-order absorption with lag time were performed. Sixteen subjects completed the study. The geometric mean ratio (GMR) (90% confidence intervals [CI]) for maximum concentration (C max ), and area under the concentration-time profile from 0 to the last measurable time (AUC last ) after Y75T of Cohort B to those of Y75T of Cohort A were 1.2273 (1.0245–1.4701), and 2.4146 (1.8142–3.2138), respectively. The GMR (90% CI) for C max , and AUC last after Y75T of Cohort B to those of Y150T of Cohort A were 0.6476 (0.5229–0.8021), and 1.1471 (0.8418–1.5632), respectively. Simulated steady-steady pregabalin concentrations after once-daily Y75T dosing in subjects with eGFR 45 mL/min/1.73 m 2 were within the range of steady-state concentrations simulated after once-daily Y150T dosing in subjects with eGFR 90 mL/min/1.73 m 2 . The total pregabalin exposure of Y75T in patients with moderate renal impairment was comparable with that of Y150T in subjects with near-normal renal function.

Fixed-dose combinations development requires pharmacokinetic drugdrug interaction (DDI) studies between active ingredients. For some drugs, pharmacokinetic properties such as long half-life or delayed distribution, make it difficult to conduct such clinical trials and to estimate the exact magnitude of DDI. In this study, the conventional (non-compartmental analysis and bioequivalence [BE]) and modelbased analyses were compared for their performance to evaluate DDI using amlodipine as an example. Raw data without DDI or simulated data using pharmacokinetic models were compared to the data obtained after concomitant administration.Regardless of the methodology, all the results fell within the classical BE limit. It was shown that the model-based approach may be valid as the conventional approach and reduce the possibility of DDI overestimation. Several advantages (i.e., quantitative changes in parameters and precision of confidence interval) of the model-based approach were demonstrated, and possible application methods were proposed. Therefore, it is expected that the model-based analysis is appropriately utilized according to the situation and purpose.