Post-Marketing Safety Study of Ramucirumab Plus FOLFIRI: Analysis of Age and Initial Dose of Irinotecan in Patients with Metastatic Colorectal Cancer.

Background: There is limited real-world evidence regarding the safety of ramucirumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC).

Objective: We evaluated the safety of ramucirumab plus FOLFIRI in patients with mCRC by age and initial dose of irinotecan.

Patients And Methods: This single-arm, prospective, multicenter, non-interventional, observational study was conducted between December 2016 and April 2020.

A post-marketing safety study of ramucirumab with FOLFIRI in patients with metastatic colorectal cancer.

Background: Ramucirumab [human vascular endothelial growth factor (VEGF) receptor-2 monoclonal antibody] + levofolinate, fluorouracil, and irinotecan (FOLFIRI) was approved for the treatment of metastatic colorectal cancer (CRC) in Japan based on the results from the phase 3 RAISE trial (NCT01183780). However, safety information of ramucirumab + FOLFIRI in the real-world setting is limited. Therefore, the present study was conducted to evaluate the safety of ramucirumab + FOLFIRI under routine clinical practice in patients with metastatic CRC (mCRC) after first-line chemotherapy.

The clinical position of ramucirumab-containing regimens for advanced gastric cancer: a review of clinical trial data.

Despite the availability of multiple treatment options, the prognosis for advanced gastric cancer (AGC) remains poor and more effective treatment options are needed. Ramucirumab is an established and recommended second-line treatment for AGC. In recently completed and ongoing clinical trials, ramucirumab has been investigated in combination with new therapeutics and in new clinical settings to address the unmet treatment needs of AGC.

Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study.

To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice. This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.

Population pharmacokinetic-pharmacodynamic target attainment analysis of imipenem plasma and urine data in neonates and children.

Background: Population pharmacokinetic (PK)-pharmacodynamic target attainment analysis of imipenem was performed to elucidate the PK properties in neonates and children and to rationalize and optimize dosing regimens.

Methods: Population PK models were separately developed in neonates and children by simultaneously fitting plasma and urine data from 60 neonates and 39 children. The newly developed models were then used to estimate the probability of attaining the pharmacodynamic target (40% of the time above the minimum inhibitory concentration) against clinical isolates of common bacteria in pediatric patients.

Penetration of meropenem into human pancreatic juice.

This study examined the penetration of meropenem into pancreatic juice in patients who had undergone hepato-biliary-pancreatic surgery. The patients received a 0.5-h infusion of 500 mg meropenem.

Optimisation of imipenem regimens in patients with impaired renal function by pharmacokinetic-pharmacodynamic target attainment analysis of plasma and urinary concentration data.

In this study, a pharmacokinetic-pharmacodynamic (PK-PD) target attainment analysis of imipenem (IPM) in patients with impaired renal function was conducted. IPM (500 mg) was administered via a 0.5-h or 1-h infusion to 27 patients with varying renal function.

Phase I dose escalation and pharmacokinetic study of oral enzastaurin (LY317615) in advanced solid tumors.

Enzastaurin is an oral serine/threonine kinase inhibitor that targets the protein kinase C (PKC) and phosphoinositide 3-kinase/AKT pathways to induce apoptosis and suppress proliferation of various cancer cell lines. This phase I study evaluated the tolerability and pharmacokinetics of enzastaurin in Japanese patients with advanced solid tumors and determined the recommended dose for phase II. Eligible patients had advanced solid tumors and an Eastern Cooperative Oncology Group performance status of 0-2.

[Detection of the preservative chlorphenesin in cosmetics by high-performance liquid chromatography].

A simple determination method for preservative chlorphenesin in cosmetics was developed. Cosmetic samples were dissolved in methanol. The sample solution was analyzed by high-performance liquid chromatography (HPLC) with ODS column, using water-methanol (55:45) or water-acetonitrile (3:1) adjusted to pH 2.

[Studies for analyzing restricted ingredients such as phenylbenzoimidazole sulfonic acid].

Phenylbenzoimidazol sulfonic acid (PBS) is a kind of sunscreens in cosmetics and is nominated as the restricted ingredients in cosmetics in Japanese Pharmaceutical Affairs Act. So the analytical method for PBS was investigated by HPLC. 1.

[Studies for analyzing restricted ingredients such as sodium benzoate].

Sodium benzoate is a kind of preservatives in cosmetics and is nominated as the restricted ingredients in cosmetics in Japanese Pharmaceutical Affairs Act. So the analytical method for sodium benzoate was investigated by HPLC. After adding 5 ml of tetrahydrofuran to 0.

Syntheses of potential metabolites of a potent kappa-opioid receptor agonist, TRK-820.

Chemical syntheses of three kinds of potential metabolites of TRK-820, a potent kappa-opioid receptor agonist, were described. One of the potential metabolites 2, 17-N-dealkylated TRK-820, was synthesized starting from noroxycodone through 8 steps in 21% total yield. Glucuronidation of intermediate 10 and compound 1, the free base of TRK-820, was carried out stereoselectively to give 3-O-beta-D-glucuronides 15 and 16 in good yields, respectively.