No abstract available.
Therapeutic Equivalency*

The bioequivalence of two formulations (reference and Vietnamese tested formulation) of racemic chlorpheniramine combined with phenylpropanolamine was assessed in an open-labeled, randomized, crossover two-period study in 12 healthy Vietnamese males aged between 22 and 43 years old, weight between 48kg and 72kg. All 12 subjects received both formulations after an overnight fast and a 7 day wash-out period. Plasma samples were collected up to 168 hours. Plasma concentrations of total chlorpheniramine and individual enantiomers were determined with a validated chiral HPLC method and pharmacokinetic parameters were estimated using a model independent analysis. Bioequivalence was assessed by several different published statistical methods (ANOVA, Confidence Interval, Westlake, and Schuirmann). Results showed that bioequivalence may depend on the statistical and analytical methods used
Chlorpheniramine ; Therapeutic Equivalency

No abstract available.
Adult* ; Humans ; Therapeutic Equivalency*

No abstract available.
Chromatography, Liquid* ; Ciprofloxacin* ; Therapeutic Equivalency*

The structural complexity of crossover studies for bioequivalence test confuses analysts and leaves them a hard choice among various programs. Our study reviews PROC GLM and PROC MIXED in SAS and compares widely used SAS codes for crossover studies. PROC MIXED based on REML is more recommended since it provides best linear unbiased estimator of the random between-subject effects and its variance. Our study also considers the covariance structure within subject over period which most PK/PD studies and crossover studies ignore. The QT interval data after the administration of moxifloxacin for a fixed time point are analyzed for the comparison of representative SAS codes for crossover studies.
Cross-Over Studies* ; Therapeutic Equivalency

A bioequivalence study is usually conducted with the same-day drug administration. However, hospitalization is occasionally separated for logistical, operational, or other reasons. Recently, there was a case of separate hospitalization because of difficulties in subject recruitment. This article suggests a better way of bioequivalence data analysis for the case of separate hospitalization. The key features are (1) considering the hospitalization date as a random effect than a fixed effect and 2) using “PROC MIXED” instead of “PROC GLM” to include incomplete subject data.
Hospitalization* ; Statistics as Topic* ; Therapeutic Equivalency*

Bioequivalents of two preparations composing of Ranitidine. A randomised crossover controlled single dose study was performed on 18 healthy volumteers (9 males and 5 females) aged from 22 to 40 years old. For each subject of each preparation 1 tablet composing of 150mg of ranitidine was administered orally. Plasma levels of ranitidine were evaluated by HPLC. The dissolution rate of different preparations showed that their properties were similar. Bioequivalent was evalnated statistacally (by diverse methods as ANOVA, confidence interval, West lke and Schurimann). No significant difference in plasma level of these 2 preparations was reforted. No side effect was noted
Ranitidine ; Therapeutic Equivalency ; Pharmaceutical Preparations

OBJECTIVETo explore the way for testing of multivariate in therapeutical equivalence.

METHODSBy improved Hotelling T(2) test, the mean vector of two groups was tested. The information of each variable could then be obtained by deducting the their correlations. "Clinical Equivalence of Drug A and Drug B for Postmenopausal Bone Looseness" was used in this research. The primary measure of efficacy was regarded as the improvement rate of four variables with predefined limit of equivalence (2%) with the results of univariate test and multivariate test compared.

RESULTSUnder P > alpha, all the variables were nonequivalent. Under P

CONCLUSIONWith the combination of the filtration of nonequivalent variables and the improved Hotelling T(2) test, the test of multivariate could be done. The method is reasonable and practical.

Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar experimental conditions in either a single dose or multiple doses in an appropriately designed study. If a drug is to be bioequivalent to the reference drug, the confidence interval for both pharmacokinetic parameters, AUC(area under the plasma concentration-time curve) and Cmax(maximal plasma concentration), must be entirely within the 80% to 125% of those of the reference drug. Underlying the concept of bioequivalence is the thesis that, if a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is equivalent and can be substituted for that drug product. The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent. In this paper the general concept and the practical significance of the bioequivalence is described. The recently revised Korean guideline for bioequivalence test is also discussed.
Drug Substitution ; Humans ; Molar ; Plasma ; Therapeutic Equivalency*

BACKGROUND: Voglibose is an alpha-glucosidase inhibitor. The purpose of this study was to evaluate the pharmacodynamic characteristics of voglibose for determining the appropriate study design and parameters for a pharmacodynamic equivalence study of voglibose. METHODS: This study consisted of two studies. The single dose study had an open and single sequence design. Nineteen subjects received placebo and then one tablet of voglibose on two consecutive days with sucrose. The multiple dose study was performed with the similar design, except that it was a multiple dose of the single dose study. Nine subjects who showed an effective response in the single dose study received placebo three times and then voglibose 4 times on two consecutive days. Serial blood samples for pharmacodynamic parameters were taken until 180 mins after each administration. The baseline adjusted maximum serum glucose level (G(max)) and area under the serum glucose level-time profiles were determined and compared. RESULTS: In the single dose study, the difference in G(max) was -10.6 +/- 28.7 mg/dL. The area under the serum glucose concentration-time curve (AUGC(0-1h)) of placebo and voglibose were 7825.0 +/- 1145.3 mg.min/dL, 7907.5 +/- 917.2 mg.min/dL, respectively. In the multiple dose study, the difference in G(max) was 46.6 +/- 16.1 mg/dL. The AUGC(0-1h) of placebo and voglibose were 8138.6 +/- 721.9 mg.min/dL and 6499.7 +/- 447.2 mg.min/dL, respectively. The G(max) and AUGC(0-1h) of the multiple dose study was significantly different between placebo and voglibose in paired t-test. CONCLUSION: The differences in G(max) and AUGC(0-1h) are suitable for pharmacodynamic parameters to evaluate bioequivalence of voglibose.
alpha-Glucosidases ; Glucose ; Inositol ; Sucrose ; Therapeutic Equivalency