75 results about "Trial drug" patented technology

Treatment of Cancer Methods for treatment of cancer, in particular soft tissue sarcomas (STS), are described, as well as compounds, compositions, and combined preparations for use in such methods. An effective amount of: a LAG-3 protein, or a derivative thereof that is able to bind to MHC class II molecules; a programmed cell death protein-1 (PD-1) pathway inhibitor; and radiotherapy, is administered to a subject. Optionally the subject has undergone, is undergoing, or is to undergo, surgery for treatment of the cancer. A clinical trial study is described in which a triple combination of LAG-3 derivative eftilagimod alpha, a PD-1 pathway inhibitor, and radiotherapy was administered. The combination was surprisingly effective in the treatment of STS in patients who have completed 10 weeks of treatment, followed by surgery 2-3 weeks later. A substantial number of near complete pathological responses were observed, which are rarely seen in STS patients with standard therapeutic approaches including radiotherapy.

The invention relates to an intelligent drug management method and system in a drug clinical test process, and the method comprises the steps: obtaining a clinical test scheme, determining a drug clinical test standard according to the clinical test scheme, searching potential subjects, and transmitting a recommendation list to the potential subjects; in the clinical test process, acquiring multi-dimensional clinical test information of a subject corresponding to the target drug, extracting target data associated with the safety of the subject corresponding to the clinical test scheme in the multi-dimensional clinical test information, acquiring risk index data through the target data, and performing risk assessment; after a clinical test is finished, visit information is configured according to a clinical test scheme, the visit information comprises a visit base line, a visit window, a visit period and visit examination items, a visit schedule table is generated based on the visit information, remote monitoring is further carried out under the condition of being not affected by area and time factors, and the visit schedule table is displayed on the basis of all doctor-seeing data of a subject. A subject panoramic data view is formed.

The invention disclosed concerns a fixed dose combination (FDC) of pertuzumab, trastuzumab, and, optionally, recombinant human hyaluronidase (rHuPH20), which is administered subcutaneously to patients. The final efficacy and safety data for the FeDeriCa clinical trial, United States Prescribing Information (USPI) (including home-use) methods, and primary analysis of the PHranceSCa clinical trial are disclosed and claimed.

The invention relates to the technical field of medical management, in particular to a clinical test drug full-process block chain tracing and intelligent management system, which comprises a drug identity identification module, a flow direction recording module, a state monitoring module, an authority distribution module and a closed-loop management module. According to the invention, through standardized generation and dynamic verification of the unique identifier of the drug, unified and standardized management of identity information is realized, traceability deviation caused by inconsistent codes in multiple links is avoided, operation time and personnel information are recorded in a circulation path and rules are compared, clear and transparent drug destination is ensured, and omission and abnormal risks are reduced. The state is recognized in real time, the target is compared, the abnormity is early warned in time, the safety and controllability of the process are improved, the authority of participants is differentially recognized, the strategy is dynamically adjusted, fine management is achieved, potential safety hazards caused by over-wide or over-narrow authority are prevented, the recovery path and resource distribution are optimized, and the recovery efficiency and integrity are improved. And closed-loop management of the whole life cycle of the medicine is formed.

The present invention relates to pharmacogenetics, more specifically to strategies involving biomarkers associated with the clinical response to a compound before or during treatment of a cartilage disorder, such as osteoarthritis. The present invention more particularly relates to the combination of JSW measurements and level of specific proteins present in the blood, serum, synovial fluid or in the urine, which can be used in strategies such as patients' enrichment in clinical trials, patients' selection strategy before or during treatment or for adapting the treatment of a patient in the frame of treatments for cartilage disorder, such as osteoarthritis.

The application discloses a drug synergistic effect prediction method based on a biomedical knowledge graph and a Transformer, and relates to a drug synergistic effect prediction method. In order to solve the problem that a traditional drug combination discovery process mainly depends on clinical trials, which is not only time-consuming and laborious, but also high in cost and risky to patients, the application comprises the following steps: extracting drug data samples, generating a data set, dividing training and test sets, performing network training and testing; constructing a biomedical knowledge graph; converting a sequence list of a drug structure into a graph by using Rdkit; mining a subgraph of the knowledge graph by using a multi-hop subgraph mining network; learning feature representations of the knowledge network and the drug molecular graph by using a relation-aware Transformer, and performing fusion; performing synergistic effect prediction between drug pairs by using a multilayer perception machine; inputting drug pairs in a training set into the above model; inputting drug pairs in a test set into the prediction model to obtain a prediction result. The application belongs to the technical field of drug synergistic effect prediction.

The utility model relates to the technical field of medicine production, and discloses clinical test medicine subpackaging equipment which comprises an L-shaped mounting plate, a subpackaging box is fixed to one side of the top of the L-shaped mounting plate, a screening mechanism for conducting vibration screening on medicine is arranged in the subpackaging box, and a driving device for driving the screening mechanism is arranged on one side of the subpackaging box. The screening mechanism comprises sliding grooves formed in the two ends of the inner wall of the subpackaging box, guide rods are fixed to the two sides of the inner walls of the two sliding grooves, sliding blocks are arranged on the outer walls of the two guide rods in a sliding mode, the same screening frame is fixed to the faces, close to one another, of the four sliding blocks, and rolling wheels are rotationally connected to the tops and the bottoms of the multiple sliding blocks. According to the medicine screening device, through left-right shaking of the sliding blocks, medicine can be effectively and evenly dispersed in the screening frame, tablets are prevented from being adhered together, mistaken weighing or mistaken packaging caused by adhesion of the medicine is effectively avoided, and potential quality safety hazards are reduced.

The invention provides a drug research and development and individualized treatment platform based on an artificial neural network and a multi-modal artificial intelligence technology, and the platform is characterized in that the platform comprises the following specific steps: S1, data preparation and preprocessing: collecting multi-modal drug data, target data and clinical data, and carrying out the standardization processing; s2, constructing and training a model, generating drug molecules by using VAE and GAN, predicting interaction between a drug and a target spot by using GNN, optimizing an individualized treatment scheme through reinforcement learning, predicting adverse drug reactions by using self-supervised learning, and protecting sensitive data by using federal learning and differential privacy to realize cross-mechanism cooperation; s3, verifying and optimizing the model, verifying the performance of the model through laboratory and clinical tests, and optimizing through feedback data; and S4, system deployment and application: all modules are integrated to a drug research and development and treatment platform, and the efficiency and precision of drug development and individualized treatment are improved.

The present invention discloses the use of combined GC triamcinolone enema in the treatment of immune checkpoint inhibitor-related immune enteritis. The present invention proves through clinical trial cases that intravenous administration of GC methylprednisolone combined with (triamcinolone) enema administration is beneficial to the improvement of the condition of immune checkpoint inhibitor-related immune enteritis. Therefore, combined GC (triamcinolone) enema can be used in related fields such as immune checkpoint inhibitor-related immune enteritis. The present invention provides a new drug and treatment idea for the treatment of immune checkpoint inhibitor-related immune enteritis; the present invention opens up a new use for GC (triamcinolone) enema administration and provides a new treatment method for immune checkpoint inhibitor-related immune enteritis, having good clinical application prospects. The combined medication scheme provided by the present invention has been fully clinically verified in terms of its effectiveness and safety; it is easily acceptable to patients and has unique advantages.

The invention discloses application of glucoraphanin to preparation of a product for reducing biological accumulation of perfluorooctane sulfonate, and belongs to the technical field of biological medicine. The occurrence probability of the high PFOS level in the body of a participant frequently eating broccoli is confirmed to be remarkably reduced through population epidemiological experiments, and then the PFOS level in the body of the participant is confirmed to be remarkably reduced after glucoraphanin intervention through clinical RCT random control experiments. The glucoraphanin-intervened serum has the advantages that the glucoraphanin-intervened serum is used as a main body, the metabolic change of steroid, ceramide and bile acid in the glucoraphanin-intervened serum is confirmed to be closely related to the reduction of the PFOS level through lipidomics analysis, and finally, the glucoraphanin is confirmed to be capable of effectively reducing the PFOS in-vivo accumulation and improving the liver injury caused by the PFOS through animal experiments and an AI reverse targeting technology; and the glucoraphanin and the in-vivo metabolite sulforaphane thereof have relatively strong binding capacity with a liver-specific PXR receptor, so that a good technical foundation is laid for research and development of drugs for treating diseases related to PFOS accumulation.

This invention is a method, system, and platform for risk management and decision support in pharmaceuticals, including strategic portfolio management, regulatory affairs, clinical drug development, pharmacoeconomic, investment strategy optimization, risk management, due diligence for mergers and acquisitions, and the stock market. The system uses artificial intelligence and diverse data from open and private sources, including clinical trials, regulatory decisions, economic data, pharmacological data, and corporate data. It integrates multiple decision-making modules for clinical development, such as clinical risk, regulatory risk, pharmacological risk, and economic risk. This network of risk factors generates predictive and prescriptive information for strategic decision-making.

The invention relates to the technical field of digital processing, in particular to a patient information automatic processing system and method. The method comprises the following steps: S1, acquiring first acquisition information, wherein the first acquisition information comprises historical case information; s2, according to the historical case information and the key information of the medicine to be clinically tested, screening a plurality of tested patients matched with the medicine to be clinically tested; s3, acquiring second acquisition information; s4, according to the second collection information, safety level judgment is carried out on each tested patient, safety levels judged by a second processing module include low safety, medium safety and high safety, and the clinical drug test is stopped for the tested patients judged to be low safety and the like; s5, screening the information of each tested patient in the clinical drug test stage into conventional data and key data; according to the invention, the accuracy of clinical drug tests and the safety of tested patients are ensured.

The invention provides a digital organoid construction method, equipment, a medium and a program product, and further provides a method, equipment, a medium and a program product for developing and predicting therapeutic schedule and / or therapeutic drug sensitivity based on a model, and relates to the field of intelligent medical treatment. The constructed digital organoid is widely applied to daily clinical practice, and the model can help to select the most suitable scheme from candidate schemes; in clinical trials, the model can help select patients who may respond to new test regimens, even previously abandoned regimens, and the model can predict drug response even if the treatment regimens contain new drugs not contained in the training set.

This invention discloses a clinical trial drug cabinet and a clinical trial drug management method. The clinical trial drug cabinet includes a connected cabinet body and a cabinet door, with the interior of the cabinet body and the cabinet door forming a storage space. A weighing platform divides the storage space into multiple layers of clinical trial drug storage spaces. Each layer of clinical trial drug storage space is equipped with an electronic tag reader. By cooperating with the weighing platform and the electronic tag reader, it is possible to determine which clinical trial drug is currently being placed in or taken out of the cabinet, as well as the original storage space where the clinical trial drug was placed, or from which clinical trial drug was taken out. This effectively avoids drug management chaos and improves drug storage and retrieval efficiency.

The present invention belongs to the field of drug design and specifically discloses a virtual screening method for small molecule inhibitors targeting the YTHDF1 protein, comprising: obtaining the YTHDF1 protein structure and generating multiple conformational proteins through homology modeling; obtaining a small molecule that binds to the YTHDF1 protein and generating a bait molecule to form a ligand molecule; docking the ligand molecule with the binding site on YTHDF1 and characterizing the complex through PLEC fingerprinting; using a machine learning algorithm to construct a specificity scoring function, scoring and screening the complexes of the docked compounds to be screened and the YTHDF1 molecule, and then performing affinity prediction to screen small molecule inhibitors targeting YTHDF1. The virtual screening method provided by the present invention can screen YTHDF1-targeting molecules with high affinity on a large scale and accurately, providing candidate molecules for drug development for YTHDF1-related diseases and laying the foundation for clinical trials and drug optimization.

The utility model discloses a waste liquid treatment device for drug clinical trials, which comprises a waste liquid treatment barrel and a barrel cover arranged at the top of the waste liquid treatment barrel, one side of the top of the barrel cover is fixedly connected with a liquid injection hopper, and the center of the bottom of the waste liquid treatment barrel is fixedly connected with a liquid outlet pipe; at least four supporting legs making contact with the ground are arranged on the surface of the positioning sleeve in a circumferential array mode, and a stirring shaft is rotationally connected to the center of the interior of the waste liquid treatment barrel. The device has the advantages of efficient mixing and flexible adjustment, a complex gear system is driven by a power motor, the rotary stirring function of a stirring shaft is realized, and a mechanism that a lifting threaded sleeve drives an annular sleeve and a second stirring blade to move up and down is introduced, so that a more comprehensive mixing effect is provided; and the design of a sealing ring and a lifting limiting rod ensures the safety and stability of equipment operation.

The application discloses a kind of based on artificial intelligence's pharmaceutical clinical test safety evaluation method, comprising the following steps: collecting heterogeneous clinical survival data with deletion characteristics and time series drift characteristics, and constructing original survival data set;Based on propensity score model and survival outcome model, implement deletion correction, obtain individual non-compliance risk score;Through stratified weighting rule and two-side order-preserving prediction mechanism, calibrate and update individual risk prediction interval;Calculate individual risk upper and lower bound probability, define three-domain risk threshold rule, generate real-time risk decision result through three-domain decision mapping and dynamically evaluate overall safety trend.The application improves the robustness and interpretability of clinical safety risk decision.

The invention provides a clinical test source data traceability tracking operation system, and relates to the technical field of drug clinical tests. Comprising a data identification and index end, a data acquisition and recording end, a data change tracking end, a data traceability and traceability end, a data verification and auditing end, a data access and authority control end, a data backup and recovery end and a data report and analysis end. The data identification and index end, the data acquisition and recording end, the data change tracking end, the data traceability and tracing end, the data verification and auditing end, the data access and authority control end, the data backup and recovery end and the data report and analysis end are in data communication through a private network and a private line network. The system aims at monitoring and managing links such as sources, acquisition, recording and change of clinical test data so as to ensure the reliability and credibility of the data.

This invention provides a drug clinical trial subject management system and method. The system includes: a learnable model construction module for building a learnable model; a subject screening module for inputting multi-dimensional characteristics of subjects into the learnable model for analysis and screening to obtain target subjects; an informed consent management module for managing the informed consent signing information of target subjects; a subject grouping module for grouping target subject data; a trial process management module for real-time monitoring and management of post-trial observation data of grouped target subjects; and a learnable model relearning module for retraining and updating the learnable model after the completion of the current clinical trial. This provides more efficient and accurate subject screening and grouping services for clinical trials, helping to improve the success rate and research value of clinical trials, and enhancing the accuracy of model predictions.

Disclosed is an application of Teruravone in the preparation of a drug for treating the amyotrophic lateral sclerosis disease. Teruravone can significantly increase the survival rate of TDP-43 M337V stably transfected cells and reduce the LDH leakage rate, and has a potency superior to that of Edaravone, indicating that Teruravone possesses stronger neuroprotective activity. Preliminary clinical trials indicate that after oral administration of Teruravone to an ALS patient for 3 months, the Norris Scale score and the neurofilament light chain protein level in the blood remained generally stable, and the decline in ALSFRS-R score was significantly slowed. Thus, the clinical effect of delaying the disease course of ALS is achieved, and no serious adverse effects were observed.

Provided are a crystal form of a compound, a preparation method therefor and a use thereof. The compound has a structure as shown in formula I. The crystal form has high crystalline purity, low hygroscopicity, good solid-state stability and good solubility, is beneficial to the preparation and storage of pharmaceutical formulations, and has good application value and drug development potential. In addition, clinical trial results further demonstrate that the crystal form B of the compound as shown in formula I has good pharmacokinetic properties, low clinical toxicity, good safety, high oral bioavailability, and good therapeutic efficacy against multiple diseases.

The invention discloses a propofol-metoprolol twin drug as well as a preparation method and application thereof, the propofol-metoprolol twin drug is formed by connecting propofol and metoprolol, and the propofol-metoprolol twin drug is named as WSW-E01-166-P. According to the present invention, the WSW-E01-166-P can achieve the deanesthesia effect, and has good drug stability; the compound has relatively high inhibition efficiency on ICa-L, and shows an anti-arrhythmia effect in a barium chloride induced ventricular arrhythmia rat model. The novel twin drug WSW-E01-166-P disclosed by the invention has relatively good performance in the aspects of IVAs resistance, pharmacokinetics, toxicology and the like, and is greatly helpful for later promotion of entering a phase I clinical research process.

The invention relates to application of a medicine for inhibiting glioma progression promoted by chronic pressure stress, and relates to the technical field of biological medicine, chronic pressure stress is proved to be a key risk factor for promoting glioma progression, but a cell molecular mechanism behind the chronic pressure stress is not clear yet. Therefore, a targeting drug capable of specifically intervening in the process is lacked clinically. Existing immunotherapy such as adoptive NK cell therapy is poor in effect in glioma clinical tests, it is prompted that pressure stress possibly induces a strong immunosuppression microenvironment, and the technical scheme with a C5aR inhibitor Avacopan as the core is provided. According to the means, the activity of a key node C5aR1 in a pressure stress signal channel is blocked through a pharmacological method, functional inhibitory stress-related macrophages (SAMs) are cleared in a targeted manner, so that immunosuppression is reversed, glioma growth driven by chronic pressure stress can be selectively inhibited, and a synergistic interaction effect with an NK cell therapy is shown in an in-vivo experiment.

Disclosed in the present invention are a crystal form of a compound, and a preparation method therefor and the use thereof. The compound has a structure as represented by formula I. The crystal form has high crystal purity, low hygroscopicity, good solid-state stability and good solubility, and is thus beneficial for the preparation and storage of a pharmaceutical formulation and has great application value and has the prospect of becoming a medicine. In addition, the results of clinical trials further show that the crystal form A of the compound as represented by formula I of the present invention has great pharmacokinetic properties, low clinical toxicity, good safety, high oral bioavailability and good therapeutic effects on various diseases.

The invention provides a PD classification identification optimization method based on I-III stage drug clinical test nursing, and relates to the technical field of drug clinical test nursing management. The method comprises the following steps: collecting I-III phase drug clinical test nursing related data, and screening PD data; dividing the PD into three categories, namely test drug configuration or use deviation, sample collection or treatment deviation and vital sign detection deviation, and judging the severity; the PD core root is analyzed in combination with test item types, medicine dosage forms and nursing working modes; the matching system comprises a data acquisition module, a classification identification module, a root analysis module, an optimization strategy output module and a dynamic monitoring module. According to the method, the defects of fuzzy PD classification, inaccurate root analysis and insufficient prevention and control strategy pertinence in the prior art are overcome, the PD risk point can be accurately positioned, the PD occurrence rate is effectively reduced, the clinical test nursing quality is improved, the test risk is reduced, and the method has good practicability and popularization value.

The invention provides an inhibitor of a targeted esophageal cancer pathway. The inhibitor has a specific structural general formula, can specifically target an esophageal cancer pathway, and inhibits growth and proliferation of tumor cells. The preparation process comprises the steps of raw material preparation, reaction and purification, is simple and efficient, and is suitable for large-scale production; research and development of the inhibitor are based on deep understanding of esophageal cancer pathways, and survival mechanisms of tumor cells can be effectively interfered by accurately regulating and controlling key signal transduction paths. Clinical tests show that the inhibitor has a remarkable inhibition effect on various types of esophageal cancers, is small in side effect and has a good clinical application prospect. In addition, the preparation process is simple, convenient and economical, the high purity of the product can be ensured, the production efficiency is improved, the production cost is reduced, and favorable conditions are provided for large-scale industrial production. Therefore, the invention provides an innovative and effective choice for the treatment of esophageal cancer.

A computer-based method and system for predicting preclinical pharmacokinetics of a therapeutic agent. Dosage regimen data associated with a dosage regimen of a therapy is received. Also received is medical data associated with a subject. Model input data is formed using the dosage regimen data and the medical data. Using a machine learning model and the model input data, a predicted pharmacokinetic (PK) outcome output is generated. The machine learning model may be a neural ordinary differential equation (NODE) system. A recommendation for a clinical trial is formed, using the predicted PK output.

This invention belongs to the field of biomedicine, specifically relating to the application of APOL2 (Apolipoprotein L2) inhibitors in the preparation of products for treating liver fibrosis. The inventors isolated a series of natural tetrodopane-type diterpenes from *Euphorbia pekinensis*, a plant in the Euphorbiaceae family. Anti-liver fibrosis-related activity tests on this series of diterpenes revealed that they significantly inhibited the expression of fibronectin, type I collagen, and α-smooth muscle actin in LX-2 cells. In animal studies, their therapeutic effect was superior to that of pirfenidone, a phase II clinical trial drug for treating liver fibrosis, and they showed no significant toxicity. Mechanistic studies showed that TD1 is an APOL2 inhibitor, and knocking out APOL2 protein in vivo can alleviate the progression of liver fibrosis. In summary, this series of tetrodopane-type diterpenes, especially TD1, shows promise as a candidate drug for treating liver fibrosis and provides a new target for researching novel drugs for treating liver fibrosis.

This invention provides a method capable of realizing an efficient clinical trial in which development situations of drugs of competitor companies are considered. In a preferable aspect of the present invention, a clinical trial planning device is provided which includes a clinical trial planning unit. The clinical trial planning unit includes a development progress degree calculating unit calculating a development progress degree of a second drug of which patient indication corresponds to that of a first drug for which a clinical trial is to be planned, on the basis of a competitive drug design indicating a situation of a clinical trial related to the second drug, and generates a clinical trial plan obtained by optimizing a period of a clinical trial of the first drug and expected sales of the first drug on the basis of the development progress degree.

The invention belongs to the technical field of new application of medicines, and provides application of hippocampus multi-penis pills in preparation of medicines for improving or treating polycystic ovarian syndrome. In a clinical test, the hippocampus multi-penis pill is applied to a patient with the spleen-kidney yang deficiency type polycystic ovarian syndrome, the treatment effect is remarkable, the ovarian function of the patient can be effectively improved, and the endocrine system and the body metabolism function can be adjusted. Clinical test results show that the hippocampus multi-penis pill has a certain application prospect in preparation of medicines for improving or treating polycystic ovarian syndrome.