ABSTRACT
Generic drug products (test products: drug A, B...) are bioequivalent to an innovator product (reference product) when their bioavailabilities in the same molar dose are similar. Bioavailability is usually expressed by following pharmacokinetic parameters: the area under plasma concentration-time curve (AUC), the maximum plasma concentration (Cmax) and the time of maximum plasma concentration (tmax). This paper used a two period crossover bioequivalence study to develop convenient, friendly user interface software, BA&BE Analysis to statistically process data in clinical pharmacology studies and other areas. The method involves user input of data for analysis into a grid format, setting variables and parameters, followed by one-way analysis of variance (ANOVA), bioavailability and bioequivalence analysis of the data. The software developed in the present study should help scientists to carry out data analysis of bioavailability and bioequivalence testing quickly and easily.
ABSTRACT
Qualitative data are often converted to quantitative data by ranking in pharmacodynamical statistics. Some common questions were listed and discussed with examples in this paper, including ranking method and the selection of statistical method.
ABSTRACT
NDST(New Drug Statistical Treatment)is a powerful tool for treating data of clinical trial and pre-clinical experimentation in the study of new drug. This paper, combined the some examples, introduced the new edition of the software (NDST-21) on the function and characteristics.
ABSTRACT
AIM: To investigate the therapeutic effect of tea polyphenols (TP) on cationic bovine serum albumin (C BSA) glomerulonephritis. METHODS: C BSA glomerulonephritic model was induced in rabbits. TP in three different doses (30, 100 and 300 mg?kg -1 ) was administered (ig) once daily for 14 days. RESULTS: TP not only significantly reduced the urinary protein excretion, decreased blood urea nitrogen (BUN) and plasma creatinine (Cr) levels, but also significantly relieved gloermular lesions in the rabbits treated and there was a significant dose dependent relationship between high dosage (300 mg?kg -1 ) and low dosage ( 30 mg?kg -1 ). CONCLUSION: TP can reduce proteinuria, suppress the development of glomerular impairments, and ameliorate the kidney function of rabbits with C BSA glomerulonephritis.
ABSTRACT
In clinical and experimental therapeutics, the quantitative analysis of drug interaction will supply a tool for optimizing and evaluating a combination in the study of compound drug, the design of combination drug therapy, and the evaluation of traditional medicine formulae. This paper listed the systematic methods of the quantitative analysis, including the weighted modification method for optimizing constituents, doses and ratio in combination, the parameter method and the reflection method for dynamic analysis of drug interaction, and a comprehensive method for multiple response indexes. The software CoDrug about these methods also was introduced.
ABSTRACT
Aim To set up a novel animal model of intra-abdominal adhesion and to determine whether the tissue plasminogen activator activity (PAA) in exudate can be taken as an indicator to judge the formation of the adhesion. Methods Rats were randomly divided into 2 groups. Each animal in both groups was opened the abdominal cavity via midline laparotomy without any disinfectant measures. 2-cm section from the cecal end was clamped and ligated, 1-cm cecum of the section was cut, and another 1-cm end from the ligated site was kept. After the content in the end was extruded, the cecum was put back without using any antibacterial agent. Before the skin closure, an effective combination AMD (allantoin, metronidazole and dexamethasone in combination), was given (ip) according to 1.5 ml per 100 g body weight (60.6 mg·kg-1). The control group was injected (ip) the same volume of normal saline. After 6 h, the exudate was extracted from drainage-tube, with the rats varying posture, and after 1 kw, the rats were killed for examining the intra-abdominal adhesion. The values of PAA of exudate in both groups were analyzed by the relative operating characteristic curve (ROC). Results In the control group, all 20 rats formed the adhesions, the amount of exudate=(1.25±0.09) ml, the number of WBC(×103)=(23.1±6.6) mm3 and PAA=(0.9±0.4) IU·ml-1 in the exudate of abdominal cavity. In AMD group, however, there was not the adhesion formations (0/20), the amount of exuade was (0.52±0.04) ml (P<0.01), the number of WBC (×103) (10.6±4.2) mm3 (P<0.01), and PAA (23.1±6.6) IU·ml-1(P<0.01) in exuade.ROC analysis indicated that if PAA >1.24 IU·ml-1 in the exuade, the adhesion was difficult to form, and vice versa. Conclusion This animal model can be taken as an effective tool to evaluate the human adhesion related to multi-links on the pathogenesis, and the PAA in exudate an indicator to judge intra-abdominal adhesion formation.
ABSTRACT
The principle of the relative operating characteristic (ROC) curve, along with constructing curve, a cutoff value between therapeutic and non-therapeutic concentration, formula for calculation, and statistic analysis, was introduced. Illustrated by an example, ROC was an important tool in analysis of the fixed effect model. It can beapplied to determine the relationship between a blood concentration and its action, probability of certain concentration producing therapeutic action, and high or low limit of therapeutic window, etc.
ABSTRACT
Pharmacokinetics of Tetramethylpyrazine Hydrochloride (TMPH) in rat was studied by using Ultraviolet Spectrophotometry. After a bolus iv injection of TMPH 30 mg/kg to rat, the pharmacokinetic characteristics are found to fit a two-compartment open model. The Pharmacokinetic parameters are: t 1/2? = 0 .1441h, t 1/2? = l .6953h, K21=2.1850h-1, K10=0.8605h-1, K12= 2 .0723h-1, AUC = 83 .3660mg?L -1h, CL = 0.3599L?kg-1h-1, Yc =0 .4182L?kg-1 , Vss =0 .7975L.kg-1