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原文文本 - English英语 Atrasentan was well tolerated following acute oral and intraperitoneal dosing in rodents, with adverse effects being limited to very high dose groups. Clinical signs included dyspnea, decreased activity, and prostration in both rats and mice and diarrhea in rats. Convulsions and cachexia were seen only with intraperitoneal administration in mice. Hematologic changes were noted in both the rat and dog repeat-dose studies. Increases in hematocrit, hemoglobin, red blood cell numbers and reticulocytes were observed in rats; there was a tendency for these same parameters to decrease in dogs. Elevations in erythropoietin were also noted in rats with high hematocrits. There was no evidence of bone marrow suppression, hemorrhage or red blood cell destruction in the dog toxicology studies.
原文文本 - English英语 PAPILLARY RENAL CELL CARCINOMA
The group of cancers that comprise the pRCC subtype includes pRCC type 1, pRCC type 2 and unclassified RCC with papillary architecture. These cancers are histologically,molecularly and clinically diverse.The recent publication of the TCGA pRCC study by the Cancer Genome Atlas Research Network highlighted this fact, and in their study they described several subgroups within both type 1 and type 2 tumors [5&&]. Alterations in several cancer-associated pathways were found across the spectrum of pRCC tumors, including alterations in the Hippo signaling pathway [mutationsin the NF2 (neurofibromin 2) gene], in the SWItch/Sucrose Non-Fermentable (SWI/SNF) complex [PBRM1 and SMARCB1 (SWI/SNF-related matrix-associated actin-dependent regulator of chromatin subfamily B member 1)] and in several chromatin modifier pathways [SETD2, BAP1 and KDM6A (lysine (k)-specific demethylase 6A)].
Several subgroups in pRCC type 2 were linked with particularly poor clinical outcomes. Tumors with the CpG island methylator phenotype (CIMP) had increased DNA methylation compared with locithat were unmethylated in matched normal tissue from the same patient. At the molecular and metabolic level, many of these tumors have germline or somatic mutations in fumaratehydratase. Patients with germlinefumaratehydratasemutations can develop hereditary leiomyomatosis and RCC syndrome [42]. The CIMP phenotype is not unique to pRCC and is linked with a poor clinical prognosis in a variety of human malignancies [43].
English英语译成Chinese汉语: CMC - Chemistry, Manufacturing and Control
原文文本 - English英语 IRIX HPLC method (IRIX-AP-712) is a specific and stability-indicating method used for the determination of purity and related substances of XXX. Related substances in XXX drug substance are reported as area percent. The area of an impurity is divided by the total area of all sample-related peaks from injection of a 0.3 mg/mL sample preparation. Related substances are reported by relative retention time (RRT) to the XXX parent peak and include impurities related to XXX such as synthetic byproducts and degradation products. The peak areas for all eluted compounds are summed and the purity of XXX is calculated as the percent of the total peak area.
The determination of residual solvents in XXX drug substance is based on the compendial method USP . Gas chromatography using J&W DB-624 capillary column with flame ionization detection (FID) is used to determine the amount of residual organic volatile impurities (residual solvents) per IRIX HS-GC method (IRIX-AP-59). The concentration of each solvent in the sample is determined using a standard curve generated from injection of standards with known solvent concentrations. Based on the observed signal, the solvent content of the sample is calculated as a function of the sample weight and dilution volume.
Common
Technical Documents (CTD), Chemistry, Manufacturing and Control (CMC) dossiers,
pre-clinical safety profiles, nonclinical toxicology study reports, fertility
and embryo-fetal development study, PK data, PD data, treatment related
toxicity, safety summary, protocols and protocol amendments, sponsor audits.
关键词： Translation, Chinese, Mandarin, English into Simplified Chinese, medical, pharmacology, toxicology, clinical trials, pharmaceuticals, life science. See more.Translation, Chinese, Mandarin, English into Simplified Chinese, medical, pharmacology, toxicology, clinical trials, pharmaceuticals, life science, China, Trados. See less.
