11 results about "Bioequivalence" patented technology

The present application relates to a kind of HPLC-MS / MS detection method of detecting in human plasma, desloratadine and 3-hydroxydesloratadine in human plasma, it includes the following steps: (1) human plasma sample pretreatment;(2) liquid chromatography-mass spectrometry detection, using mobile phase A and mobile phase B as mixed mobile phase is carried out gradient elution, wherein: mobile phase A is methanol-acetonitrile mixed solution, in mixed solution methanol and acetonitrile volume ratio is 4-6:6-4;Mobile phase B is 2-20mM ammonium formate aqueous solution;(3) the determination of the concentration of human plasma in lopatadine, desloratadine and 3-hydroxydesloratadine.The present application uses lopatadine-d4, desloratadine-d5, 3-hydroxydesloratadine-d4 as deuterium internal standard, using Agilent, ZORBAX Eclipse XDB-Phenyl is carried out gradient elution, deuterium internal standard and the measured substance has the same retention time, chemical property and matrix effect, the reproducibility, accuracy of determining the concentration of lopatadine, desloratadine and 3-hydroxydesloratadine in plasma are good.The method of the present application can be used to evaluate the bioequivalence of lopatadine.

The application discloses a complex long-acting preparation steady-state pharmacokinetics extrapolation equivalence prediction method, relates to the steady-state bioequivalence technical field, and comprises the following steps: collecting and unifying concentration-time, a drug administration scheme and a covariate, generating a standardized time, an event marker code and a covariate dictionary, setting a deletion weight and a population alignment weight; setting a candidate structure based on population pharmacokinetics, estimating a model and a covariate effect through a quality threshold determination with a weight; constructing a virtual population and performing multiple drug administration simulation to determine the reaching of stability according to the relative change of consecutive two trough concentrations, generating a peak-trough sampling time window; performing non-compartment analysis in the steady-state interval, calculating a dosing interval area, a steady-state peak value and a steady-state trough value, calculating a geometric mean ratio and a confidence interval of two preparations, carrying out efficacy-sample size linkage, and outputting a recommended design; the method can reduce the test burden, shorten the cycle and improve the decision transparency.

The application discloses a drug interaction prediction and dose reference information generation method, system and device, and the method comprises the following steps: acquiring parameters of a Bruton's tyrosine kinase inhibitor as a target drug and an antiretroviral drug as an interaction drug; constructing and verifying a basic physiological pharmacokinetic model of each drug; integrating inhibition or induction parameters of the interaction drug on corresponding enzymes, constructing and verifying an interaction prediction model; running the verified model to simulate and calculate predicted exposure data of the target drug when the drugs are used in combination; and generating dose reference information meeting preset bioequivalence conditions by iteratively adjusting dose parameters of the target drug and re-simulating. The application realizes automatic, quantitative prediction and personalized dose scheme generation of specific drug combination interactions, and can provide key decision support for clinical combination drug use.

The present application relates to a kind of HPLC-MS / MS detection method of loxoprofen and its active metabolite trans-OH body in human plasma, it includes the following steps: (1) human plasma sample pretreatment;(2) liquid chromatography-mass spectrometry detection, using mobile phase A and mobile phase B as mixed mobile phase is carried out gradient elution, wherein, mobile phase A is acetonitrile, mobile phase B is 0.05% acetic acid aqueous solution;(3) the determination of loxoprofen and its active metabolite trans-OH body concentration in human plasma.The present application uses ACE, Excel 3SuperC18 as chromatographic column, in the process of gradient elution, the time of optimization elution and the proportion of mobile phase, linear range is all 0.200-40.0ng / mL, lower limit of quantification is low, sensitivity is high, reproducibility, accuracy is all better, can be used to evaluate loxoprofen and its active metabolite trans-OH body each dosage form bioequivalence.

The present invention relates to a pharmaceutical compound formulation that contains sacubitril-valsartan and an SGLT-2 inhibitor as active ingredients, thereby having a synergistic effect in the treatment of heart failure, while minimizing the effects of drug dissolution between each drug to ensure bioequivalence, suppressing the generation of related substances, and exhibiting excellent stability of the active ingredients.

The invention discloses a macloxvir oral solution as well as a preparation method and application thereof, and belongs to the technical field of medical chemistry. The invention aims to solve the technical problems that the existing macloxvir preparation is inconvenient to take, slow in absorption, low in bioequivalence, tedious in preparation process and the like. The key point of the technical scheme is as follows: the oral solution of the macarovir comprises the following components: the macarovir, hydroxypropyl-beta-cyclodextrin, a flavoring agent, a pH regulator and water for injection, and the substitution degree of the hydroxypropyl-beta-cyclodextrin is 3.0-7.0.

The invention discloses an automatic verification system for bioequivalence test data, and relates to the technical field of data services, the system comprises a data acquisition module, a knowledge graph construction module, a semantic reasoning verification module, an abnormity early warning module and a collaborative updating module; bE test data are respectively collected from the clinical data management unit, the detection instrument and the laboratory information management unit, a standardized data pool is formed through format standardization processing, and standard integration of the data is realized; core entities and corresponding attributes are defined, association relationships and mapping rules among the entities are determined, and by calculating association strength among different entities, reliable entity pairs are screened, incorporated into a knowledge graph and stored, and a traceable semantic association system among data is established; and extracting to-be-verified data, performing pop-up early warning by combining entity association strength, calculating an exception judgment index and generating a verification result early warning report, and meanwhile, pushing an exception early warning mail to a data administrator to ensure that data exception is identified and handled in time.

Described herein, in part, are single-unit dosage forms, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl), wherein the composition is bioequivalent to a reference composition of the same dosage strength administered as multiple small, round tablets. The present invention further comprises methods useful for treating a disease or condition relating to aberrant function or activity of a T-type calcium channel, such as tremor (e.g., essential tremor).

This application discloses a method for determining the dissolution profile and in vivo bioequivalence of a tablet. The tablet comprises, by weight, 180-220 parts indobufen, 200-250 parts lactose, 40-60 parts microcrystalline cellulose, 10-20 parts povidone, 20-40 parts sodium carboxymethyl starch, 1-10 parts sodium dodecyl sulfate, and 1-10 parts magnesium stearate. The median particle size of the lactose in this invention is 38-60 μm, and the bulk density is 0.55-0.68 g / ml. Basket dissolution is employed, with controlled conditions including: a temperature of 37±1℃, a pH of 4.5-7.6 in the dissolution medium, purified water, and a rotation speed of 75-100 rpm. This invention, combined with an optimized dissolution detection method, can ensure that the dissolution profiles of the self-made sample and the reference formulation are similar in multiple media, and guarantees consistency with the in vivo efficacy of the reference formulation.

Described herein, in part, are single-dose dosage forms comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., a compound of Formula (II), e.g., PRAX-944 HCl), which compositions are bioequivalent to an identical dose of a reference composition administered as multiple small, round tablets. The invention further includes methods useful for treating diseases or conditions associated with abnormal function or activity of T-type calcium channels, such as tremor (e.g., essential tremor).