Purpose: This 6-year post-marketing surveillance (PMS) study was conducted in South Korea to evaluate the real-world safety and effectiveness of eribulin in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Materials and Methods: During the study period (17 August 2012 to 16 August 2018), case-report files (CRFs) of patients receiving eribulin were collected. The main study endpoint was to assess the safety of eribulin. Evaluation of the effectiveness of eribulin was an exploratory endpoint. Patients were followed for 1 year after eribulin initiation. Results: CRFs were collected from 64 investigators at 64 sites for 1,079 patients. The safety analysis set (SAS) included 1,001 eribulin recipients; effectiveness was assessed in 244 patients. In the SAS, patients were predominantly female (99.6%), with a median age of 53.0 years, and diagnosed with metastatic breast cancer (92.0%). Eribulin was administered as a median 4th line chemotherapy. A total of 2,124 treatment-emergent adverse events (TEAEs) were reported in 661 patients (66.0%). Neutropenia was the most common TEAE (32.5% of patients), occurring at a median of 9-11 days from initial eribulin administration. Overall response and disease control rates were 31.7% and 95.6%, respectively, and the median duration of eribulin use (time to treatment failure) was 3.0 months. Conclusion This large real-world PMS analysis in patients with advanced or metastatic breast cancer demonstrated the effectiveness of eribulin and found no new safety concerns relative to safety information from prior clinical and real-world studies, and approvals in South Korea and other countries.

Following the previous study, which investigated the pharmacological properties of the Technekitty injection (Tc-99m), the toxicity of a single intravenous administration of the Technekittyinjection (Tc-99m) and the side effects that may occur at the diagnostic dose were confirmed.The Technekitty injection (Tc-99m) was administered intravenously once at a dose of 0, 0.67, 2.0, and 6.0 mCi/kg to 5 male and female rats per group. Mortality, general symptom obser-vation, and weight measurement were performed for 2 weeks, followed by observation of autopsy findings. There were no deaths, and no statistically significant weight change was observed. No abnormal systemic signs related to the Technekitty injection (Tc-99m) were observed. These results confirmed that Technekitty injection (Tc-99m) can be safely admin-istered intravenously at doses up to 6.0 mCi/kg. Additionally, technetium-99m at an average dose of 2 mCi (74 MBq) has been verified as a diagnostic dose without adverse effects, al-lowing the Technekitty injection (Tc-99m) to be used safely without side effects at this dosage.This study demonstrates that the Technekitty injection (Tc-99m) has a wide safety margin, supporting its potential for clinical application. Moreover, these findings align with the nonclin-ical safety standards for radiopharmaceuticals, reinforcing its utility in veterinary medicine.The Technekitty injection (Tc-99m) is expected to be applicable for clinical diagnosis as a vet-erinary drug in Korea.

Thyroid scanning using technetium-99m ( 99mTc) is the gold standard for diagnosing feline hyperthyroidism. In cats with an overactive thyroid, a thyroid scan is the most appropriate imaging technique to detect and localize any hyperfunctional adenomatous thyroid tissue. In this study, the pharmacological properties of the Technekitty injection (Tc-99m), developed as a diagnostic agent for feline hyperthyroidism using 99mTc as an active ingredient, were tested in FRTL-5 thyroid follicular cell line and ICR mice. The percentage of cell uptake of the Tc-99m in FRTL-5 thyroid cells was 0.182 ± 0.018%, which was about 6 times higher compared to Clone 9 hepatocytes. This uptake decreased by 38.2% due to competitive inhibition by iodine (sodium iodide). In tissue distribution tests by using ICR mice, the highest distribution was observed in the liver, kidneys, spleen, lungs, and femur at 0.083 hours after administration, and this distribution decreased as the compound was excreted through the kidneys, the pri-mary excretory organ. Maximum distribution was confirmed at 1 hour in the small intestine, 6hours in the large intestine, and 2 hours in the thyroid gland. Additionally, the total amount excreted through urine and feces over 48 hours (2 days) was 78.80% of the injected dose, with 37.70% (47.84% of the total excretion) excreted through urine and 41.10% (52.16% of the total excretion) through feces. In conclusion, the Tc-99m has the same mechanism of action, potency, absorption, distribution, metabolism, and excretion characteristics as 99mTc used for feline hyperthyroidism in the United States, Europe, and other countries, because the Technekitty injection (Tc-99m) contains 99mTc as its sole active ingredient. Based on these results, the Technekitty injection (Tc-99m) is expected to be safely used in the clinical diagnosis of feline hyperthyroidism.

Following the previous study, which investigated the pharmacological properties of the Technekitty injection (Tc-99m), the toxicity of a single intravenous administration of the Technekittyinjection (Tc-99m) and the side effects that may occur at the diagnostic dose were confirmed.The Technekitty injection (Tc-99m) was administered intravenously once at a dose of 0, 0.67, 2.0, and 6.0 mCi/kg to 5 male and female rats per group. Mortality, general symptom obser-vation, and weight measurement were performed for 2 weeks, followed by observation of autopsy findings. There were no deaths, and no statistically significant weight change was observed. No abnormal systemic signs related to the Technekitty injection (Tc-99m) were observed. These results confirmed that Technekitty injection (Tc-99m) can be safely admin-istered intravenously at doses up to 6.0 mCi/kg. Additionally, technetium-99m at an average dose of 2 mCi (74 MBq) has been verified as a diagnostic dose without adverse effects, al-lowing the Technekitty injection (Tc-99m) to be used safely without side effects at this dosage.This study demonstrates that the Technekitty injection (Tc-99m) has a wide safety margin, supporting its potential for clinical application. Moreover, these findings align with the nonclin-ical safety standards for radiopharmaceuticals, reinforcing its utility in veterinary medicine.The Technekitty injection (Tc-99m) is expected to be applicable for clinical diagnosis as a vet-erinary drug in Korea.

Thyroid scanning using technetium-99m ( 99mTc) is the gold standard for diagnosing feline hyperthyroidism. In cats with an overactive thyroid, a thyroid scan is the most appropriate imaging technique to detect and localize any hyperfunctional adenomatous thyroid tissue. In this study, the pharmacological properties of the Technekitty injection (Tc-99m), developed as a diagnostic agent for feline hyperthyroidism using 99mTc as an active ingredient, were tested in FRTL-5 thyroid follicular cell line and ICR mice. The percentage of cell uptake of the Tc-99m in FRTL-5 thyroid cells was 0.182 ± 0.018%, which was about 6 times higher compared to Clone 9 hepatocytes. This uptake decreased by 38.2% due to competitive inhibition by iodine (sodium iodide). In tissue distribution tests by using ICR mice, the highest distribution was observed in the liver, kidneys, spleen, lungs, and femur at 0.083 hours after administration, and this distribution decreased as the compound was excreted through the kidneys, the pri-mary excretory organ. Maximum distribution was confirmed at 1 hour in the small intestine, 6hours in the large intestine, and 2 hours in the thyroid gland. Additionally, the total amount excreted through urine and feces over 48 hours (2 days) was 78.80% of the injected dose, with 37.70% (47.84% of the total excretion) excreted through urine and 41.10% (52.16% of the total excretion) through feces. In conclusion, the Tc-99m has the same mechanism of action, potency, absorption, distribution, metabolism, and excretion characteristics as 99mTc used for feline hyperthyroidism in the United States, Europe, and other countries, because the Technekitty injection (Tc-99m) contains 99mTc as its sole active ingredient. Based on these results, the Technekitty injection (Tc-99m) is expected to be safely used in the clinical diagnosis of feline hyperthyroidism.

Following the previous study, which investigated the pharmacological properties of the Technekitty injection (Tc-99m), the toxicity of a single intravenous administration of the Technekittyinjection (Tc-99m) and the side effects that may occur at the diagnostic dose were confirmed.The Technekitty injection (Tc-99m) was administered intravenously once at a dose of 0, 0.67, 2.0, and 6.0 mCi/kg to 5 male and female rats per group. Mortality, general symptom obser-vation, and weight measurement were performed for 2 weeks, followed by observation of autopsy findings. There were no deaths, and no statistically significant weight change was observed. No abnormal systemic signs related to the Technekitty injection (Tc-99m) were observed. These results confirmed that Technekitty injection (Tc-99m) can be safely admin-istered intravenously at doses up to 6.0 mCi/kg. Additionally, technetium-99m at an average dose of 2 mCi (74 MBq) has been verified as a diagnostic dose without adverse effects, al-lowing the Technekitty injection (Tc-99m) to be used safely without side effects at this dosage.This study demonstrates that the Technekitty injection (Tc-99m) has a wide safety margin, supporting its potential for clinical application. Moreover, these findings align with the nonclin-ical safety standards for radiopharmaceuticals, reinforcing its utility in veterinary medicine.The Technekitty injection (Tc-99m) is expected to be applicable for clinical diagnosis as a vet-erinary drug in Korea.

Thyroid scanning using technetium-99m ( 99mTc) is the gold standard for diagnosing feline hyperthyroidism. In cats with an overactive thyroid, a thyroid scan is the most appropriate imaging technique to detect and localize any hyperfunctional adenomatous thyroid tissue. In this study, the pharmacological properties of the Technekitty injection (Tc-99m), developed as a diagnostic agent for feline hyperthyroidism using 99mTc as an active ingredient, were tested in FRTL-5 thyroid follicular cell line and ICR mice. The percentage of cell uptake of the Tc-99m in FRTL-5 thyroid cells was 0.182 ± 0.018%, which was about 6 times higher compared to Clone 9 hepatocytes. This uptake decreased by 38.2% due to competitive inhibition by iodine (sodium iodide). In tissue distribution tests by using ICR mice, the highest distribution was observed in the liver, kidneys, spleen, lungs, and femur at 0.083 hours after administration, and this distribution decreased as the compound was excreted through the kidneys, the pri-mary excretory organ. Maximum distribution was confirmed at 1 hour in the small intestine, 6hours in the large intestine, and 2 hours in the thyroid gland. Additionally, the total amount excreted through urine and feces over 48 hours (2 days) was 78.80% of the injected dose, with 37.70% (47.84% of the total excretion) excreted through urine and 41.10% (52.16% of the total excretion) through feces. In conclusion, the Tc-99m has the same mechanism of action, potency, absorption, distribution, metabolism, and excretion characteristics as 99mTc used for feline hyperthyroidism in the United States, Europe, and other countries, because the Technekitty injection (Tc-99m) contains 99mTc as its sole active ingredient. Based on these results, the Technekitty injection (Tc-99m) is expected to be safely used in the clinical diagnosis of feline hyperthyroidism.

Purpose: Osteosynthesis has been recommended for treatment of Pauwels type III femoral neck fractures in young patients. However, no implant of choice has been reported so far. This study was conducted in order to compare the fixation stability of two conventional fixation methods with three different novel fixed angle devices in this type of fracture. Materials and Methods: A total of 25 composite femurs (4th Generation Saw bone; Pacific Research Laboratories, USA) corresponding to human bone were used. Pauwels type III fracture type was uniformly reproduced. Specimens were fixed with a cannulated screw, cannulated screw with cable, and Intertan nail, dynamic hip screw, and IKEY nail. Measurement of failure loads and the rotational change of the femoral head fragment was performed for evaluation of fixation stability. Results: All implants were compared with cannulated screw and dynmaic hip screw. No meaningful improvement was observed for the cannulated screw with cable compared with the cannulated screw and dynamic hip screw. Meaningful improvement in load-to-failure and y-rotation and z-rotation was observed for both the Intertan nail and IKEY nail compared with the cannulated screw. However, compared with the dynamic hip screw, only the IKEY nail showed improvement in the same profile but the Intertan nail did not. Conclusion Among novel fixed angle devices, meaningful improvement was observed for the IKEY nail compared with conventional implants. Strengths of this implant include biomechanical stability and simplicity of surgical technique, indicating that it may be another good option for osteosynthesis of Pauwels type III femoral neck fractures.

Objectives: Recently, weight loss has emerged as a national concern in South Korea, and this has resulted in an increase in the frequency of use of central nervous system (CNS)-stimulating appetite suppressants. This study aimed to collect cases of psychotic disorders and bipolar disorders triggered by phentermine and phendimetrazine and explore the clinical features and courses. Methods: In this retrospective study, we analyzed the electronic medical records of patients and selected eight patients who developed psychotic symptoms and manic symptoms for the first time after taking phentermine and phendimetrazine. All cases were reviewed, and their clinical features and course were summarized. Results: All eight patients developed psychotic symptoms, and one had accompanying manic symptoms. The final diagnosis was appetite-suppressant-induced psychotic disorder in four patients, schizophrenia in three, and appetite-suppressant-induced bipolar disorder in one. In addition, three patients were diagnosed as having substance-use disorder. The key psychotic symptoms of these patients were hallucinations and paranoia. Conclusions These case findings suggest that phentermine and phendimetrazine can cause psychotic disorder, bipolar disorder, or substance use disorder and that medical professionals and the public should practice caution when prescribing and using these drugs.

A sensitive and simple liquid chromatography-tandem mass spectrometry method was developed and validated for the simultaneous quantification of ticagrelor and its active metabolite, AR-C124910XX from 50 µL human plasma using tolbutamide as an internal standard as per regulatory guidelines. Analytes in plasma were extracted by simple protein precipitation using acetonitrile, followed by chromatographic separation with an Acclaim™ RSLC 120 C₁₈ column (2.2 µm, 2.1 × 100 mm) and a gradient acetonitrile-water mobile phase containing 0.1% formic acid within 8 min. Mass spectrometric detection and quantitation were conducted by selected reaction-monitoring on a negative electrospray ionization mode with the following transitions: m/z 521.11 → 361.10, 477.03 → 361.10, and 269.00 → 169.60 for ticagrelor, AR-C124910XX, and tolbutamide, respectively. The lower limit of quantifications was 0.2 ng/mL with linear ranges of 0.2–2,500 ng/mL (r² ≥ 0.9949) for both analytes. All validation data, including selectivity, cross-talk, precision, accuracy, matrix effect, recovery, dilution integrity, stability, and incurred sample reanalysis, were well within acceptable limits. This assay method was validated using K₂-EDTA as the specific anticoagulant. Also, the anticoagulant effect was tested by lithium heparin, sodium heparin, and K₃-EDTA. No relevant anticoagulant effect was observed. This validated method was effectively used in the determination of ticagrelor and its active metabolite, AR-C124910XX, in plasma samples from patients with myocardial infarction.
Heparin ; Humans ; Lithium ; Mass Spectrometry ; Methods ; Myocardial Infarction ; Pharmacokinetics ; Plasma ; Tolbutamide