46 results about "Clinical pharmacokinetic" patented technology

The system described herein enables clinicians and researchers to use aggregated genetic and phenotypic data from clinical trials and medical records to make the safest, most effective treatment decisions for each patient. This involves (i) the creation of a standardized ontology for genetic, phenotypic, clinical, pharmacokinetic, pharmacodynamic and other data sets, (ii) the creation of a translation engine to integrate heterogeneous data sets into a database using the standardized ontology, and (iii) the development of statistical methods to perform data validation and outcome prediction with the integrated data. The system is designed to interface with patient electronic medical records (EMRs) in hospitals and laboratories to extract a particular patient's relevant data. The system may also be used in the context of generating phenotypic predictions and enhanced medical laboratory reports for treating clinicians. The system may also be used in the context of leveraging the huge amount of data created in medical and pharmaceutical clinical trials. The ontology and validation rules are designed to be flexible so as to accommodate a disparate set of clients. The system is also designed to be flexible so that it can change to accommodate scientific progress and remain optimally configured.

The invention discloses a preparation method of sparsenatan for stabilizing isotope labeling. According to the method, 3-methyl-4-bromobenzoic acid is used as a raw material, iodoethane for deuterium labeling serves as a deuterium labeling initiator, and the sparsenatan is obtained through six-step reaction. Optimal preparation steps and reaction conditions are screened out through a large number of experiments, and the whole preparation method is reasonable in design and good in operability. The purity of the sparsenatan prepared by means of the method and used for stabilizing the isotope labeling can be higher than 99%, and the isotope abundance is higher than 99%. The sparsenatan prepared by means of the method and used for stabilizing the isotope labeling is a standard product for research on the metabolic mechanism of the sparsenatan, can be used for tracing the metabolic process of the sparsenatan in a living body and has great application and research value on clinic pharmacokinetic study.

The invention relates to a method for determining hydroxytyrosol in Beagle dog plasma, and belongs to the field of biological detection. According to the method, the concentration of hydroxytyrosol ina Beagle dog plasma sample is detected by adopting high performance liquid chromatography-electrospray ionization tandem mass spectrometry after butylurea tosylate is adopted as an internal standardand acetonitrile is adopted for protein precipitation treatment. The accuracy, precision, specificity, stability, extraction recovery rate, matrix effect and the like of the method all meet the requirements of Chemical Drug Non-Clinical Pharmacokinetic Research Technical Guidance principles issued in 2015 edition of Chinese Pharmacopoeia and NMPA2014 on biological sample analysis.

The invention discloses a cefixime impurity and a preparation method thereof, belonging to the field of pharmaceutical synthesis. The method of the present application uses cefixime as the starting material, and obtains CefiximeSulfone through acid-catalyzed esterification, oxidation, and then hydrolysis. The route design is reasonable, the raw materials are readily available, the operability is strong, the purification is convenient, the post-processing is simple, and the prepared target The purity of the product can reach more than 99.5%, which can provide a reference sample for the research of cefixime, and can provide the reference material for the analysis and research of the clinical, pharmacology and pharmacokinetics of cefixime, and has important research value in clinical pharmacokinetic research. .

The invention relates to a liquid chromatogram-tandem mass spectrum method for detecting pitavastatin in human plasma, and application to clinical pharmacokinetic research. The invention provides a method for detecting pitavastatin concentration of plasma. By the method, the pitavastatin concentration of the plasma can be analyzed through LC-MS / MS. According to the method provided by the invention, a protein precipitate pretreatment method is preferably adopted, deuterated pitavastatin serves as internal standard, Eclipse Plus Phenyl-Hexyl column isocratic elution is adopted, and electrospray ionization (ESI) tandem mass spectrum detection is adopted. By adoption of the method provided by the invention, the extraction and recovery rate of the plasma sample is 93 percent or higher and is not influenced by matrix effect, the stability of the pitavastatin is inspected by counting the pitavastatin concentration RSD% before pretreatment, the accuracy of the measured data is guaranteed, the method is high in specificity and selectivity, high in sensitivity, rapid in detection and small in use amount, and simple, reliable, high-flux and condition-controllable clinical mass-batch sample analysis requirements are met. The specificity, the stability and the like of the method provided by the invention are verified, and the method can be used for evaluating the bioequivalence of various dosage forms of pitavastatin successfully.

The invention relates to an ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS) method for determining plasma concentration of doxorubicin analogue and metabolite M3 in human plasma and provides a method for determining the concentration of doxorubicin analogue and C13 alcohol metabolite M3 in human plasma through UPLC-MS / MS. The method is carried out with formic acid water-acetonitrile as a mobile phase. The method for detecting the doxorubicin analogue and the metabolite M3 provided by the invention is high in sensitivity and good in repeatability, and can meet the requirements of quantitative analysis of clinical pharmacokinetic biological samples for treating malignant parenchymatous tumors by the doxorubicin analogue.

The invention relates to a method for determining loganin sapogenin in a biological sample and belongs to the technical field of medicine.The method includes that concentration of the loganin sapogenin in the biological sample is determined by ultra-performance liquid chromatography-electrospray ionization tandem mass spectrometry, wherein methyl alcohol in the biological sample serves a precipitation solvent; gradient elution is conducted, and a flow phase under a liquid phase condition consists of water with 0.1% formic acid and the methyl alcohol; cycloastragenol acts as an internal standard for determining the loganin sapogenin in the biological sample.The method for determining the loganin sapogenin in the biological sample has the advantage that the LC-MS-MS determining method satisfies the analysis requirements of Chinese Pharmacopoeia (2015 edition) and Technical Guidelines for Non-clinical Pharmacokinetic Studies on Chemical Drugs promulgated by SFDA (State Food and Drug Administration) in 2014 on biological samples in terms of accuracy, precision, specificity, stability, recovery rate, matrix effects and the like.

The invention discloses a preparation method of apremilast impurity, which belongs to the field of medicine synthesis. The application screens out the optimal preparation steps and reaction conditions through experiments, and obtains the apremilast impurity through four-step reaction synthesis. The process design is reasonable, the operability is strong, and the purification is convenient. The prepared apremilast impurity has a purity of more than 98%, provides test samples for the research of apremilast, and has important research value in clinical pharmacokinetic research.

The invention discloses a UPLC-MS / MS (Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry) method for rapidly detecting fruquintinib in rat plasma, and belongs to the technical fieldof pharmacokinetics. The method comprises the following steps: 1) collecting a specimen; 2) treating a plasma sample; 3) performing mass spectrometric detection; and 4) reading and recording data. Through adoption of the UPLC-MS / MS method for rapidly detecting fruquintinib in rat plasma, the concentration of the fruquintinib in the rat plasma can be detected rapidly, easily and accurately. Through the method, the pharmacokinetics of the fruquintinib in the rat plasma can be investigated; the blood concentration and clinical pharmacokinetics of the fruquintinib in human plasma can be monitored; and the preclinical application and post-clinical application of the fruquintinib are facilitated.

The invention discloses a preparation method of sparsenatan for stabilizing isotope labeling. According to the method, 3-methyl-4-bromobenzoic acid is used as a raw material, iodoethane for deuterium labeling serves as a deuterium labeling initiator, and the sparsenatan is obtained through six-step reaction. Optimal preparation steps and reaction conditions are screened out through a large number of experiments, and the whole preparation method is reasonable in design and good in operability. The purity of the sparsenatan prepared by means of the method and used for stabilizing the isotope labeling can be higher than 99%, and the isotope abundance is higher than 99%. The sparsenatan prepared by means of the method and used for stabilizing the isotope labeling is a standard product for research on the metabolic mechanism of the sparsenatan, can be used for tracing the metabolic process of the sparsenatan in a living body and has great application and research value on clinic pharmacokinetic study.

The invention relates to a UPLC-MS / MS method for detecting the concentrations of tafetinib and active metabolite SCR868 in human plasma. The invention provides the method for detecting the concentrations of the tafetinib and the active metabolite SCR868 in the human plasma through ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS / MS), wherein the method is implemented by adopting ammonium formate water-acetonitrile containing formic acid as a mobile phase. The method provided by the invention is good in specificity and high in sensitivity, the linear relation between the tafetinib and the SCR868 is good within the range of 0.2 to 50ng / mL of plasma, and the method is successfully applied to the detection of clinical pharmacokinetic samples.