The Drug Regulatory Process of the Republic of China — Taiwan's Experiences in Bioavailability and Bioequivalence

Hu, Oliver Yoa Pu; Hsiao, Mei Ling; Liu, Li Ling

doi:10.1177/009286159502900325

Cited by 2 publications

(1 citation statement)

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“…The Department of Health in Taiwan initiated the Guidance for Bioavailability (BA)/Bioequivalence (BE) Studies in 1987, to ensure the safety and efficacy of medicines. The BE study is mandated for non-parenteral drugs with systemic effects and proper distinction; these products are called surveillance drugs [ 1 – 3 ]. BA/BE studies are not mandatory in Taiwan for products which were licensed before 1987; these medicinal products are named as non-surveillance drugs.…”

Section: Introductionmentioning

confidence: 99%

A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals

Cheng

Chen

Tseng

et al. 2014

Journal of Food and Drug Analysis

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The purpose of this study is to evaluate the only available calcium p -aminosalicylate (Ca PAS) commercial product, which is one of the most commonly prescribed non-surveillance products from the Bureau of National Health Insurance (BNHI) database in Taiwan. An open-randomized, balanced, two-way crossover study was designed to evaluate the relative bioavailability (F) of a 500 mg Ca PAS F.C. tablet with a 500 mg Ca PAS suspension in 13 healthy individuals. Blood samples were collected according to a planned time schedule. The plasma concentrations of PAS were measured by a validated liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) method. Pharmacokinetic parameters of area under the plasma concentration-time curve from the time zero to the time of last quantifiable concentration (AUC 0–t ), area under the plasma concentration-time curve from time zero to infinity (AUC 0–∞ ), maximum plasma concentration (C max ), time to reach measured maximum plasma concentration (T max ), elimination half-life (T 1/2 ), and mean residence time (MRT) were determined by non-compartment methods. F was calculated by [AUC 0–∞ ] of the test drug divided by [AUC 0–∞ ] of the reference drug. The mean geometric ratios of pharmacokinetic parameters, including AUC 0–t , AUC 0–∞ , and C max obtained were 0.873, 0.874, and 0.569, respectively. The 90% confidence intervals of ln (AUC 0–t ), ln (AUC 0–∞ ), and ln (C max ) after being back natural log-transformed were (74.0–103.0%), (74.1–103.0%), and (38.4–84.3%), respectively. The relative bioavailability of the Ca PAS tablet was 87.4%.

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Section: Introductionmentioning

confidence: 99%