Chutima Manamuti currently working as a researcher of Bioequivalence Study Group, Research and Development Institute, the Government Pharmaceutical Organization (GPO), Bangkok, Thailand responsible for method development, method validation and bioanalysis in biological fluids. The Government Pharmaceutical Organization (GPO) is a state enterprise under the Ministry of Public Health of Thailand which dedicated itself to the Thai society in providing better standing of living for all Thais through a production and supply of quality medicines at affordable prices.
Quetiapine is an atypical antipsychotic which is indicated for the treatment of schizophrenia, bipolar depression and mania. A generic product of quetiapine has been developed with lower price by the Government Pharmaceutical Organization (GPO) to be an alternative choice of related physicians and patients who will gain access to the lower price medicines at the same quality and safety as the reference product. A comparative randomized, single dose, two-way crossover, open-label bioequivalence study of a generic quetiapine 25 mg tablets formulations, Quapine of GPO, Thailand and the reference product, Seroquel of AstraZeneca Pharmaceutical Co., Ltd. in healthy Thai volunteers under fasting conditions was conducted with 7 days wash-out period between the treatments to compare the rate and extent of absorption and evaluate the safety of the formulations. Blood samples were collected at predefined time points up to 48 hours and centrifuged to separate the plasma. Plasma samples were analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Non-compartmental model was used for pharmacokinetic analysis and statistical analysis. The 90% parametric confidence intervals for the ln-transformed test/reference ratios of primary pharmacokinetic parameter, AUC0-tlast, AUC0-∞ and Cmax were 102.0 (96.08-108.33), 102.1 (96.21-108.31) and 108.1 (96.52-121.09), respectively for quetiapine. These values were within the acceptable range of 80.00-125.00. These results showed that both formulations were bioequivalent in terms of rate and extent of absorption. Therefore, this study confirmed that both formulations can be used interchangeably.
Min Wu, Master in pharmaceutical chemistry (2013), Jilin University School of Pharmaceutical Sciences, China Working experience: As an Quality Assurance (2014-present) in Department of Phase I Clinical Trials Unit Responsible for: 1. More than 10 Phase I Clinical Trials 2. More than 20 BE and PK studies of chemical drugs
Prostate cancer is the second-and third-leading cause of cancer-related deaths in men and tumor growth is usually dependent on circulating androgens. Abiraterone acetate is a prodrug of abiraterone, a selective irreversible inhibitor of cytochrome P 17a-hydroxylase/C17, 20-lyase that plays a key role in the production of androgens. Abiraterone is categorized into biopharmaceutics classification system(BCS) Class 4 (low solubility, low permeability) based on the importance of solubility and permeability on drug absorption, which adds the difficulty of obtaining the bioequivalence(BE) results. The aim of this study was to evaluate the BE of two abiraterone formulations (250-mg tablets) by the reference-scaled average bioequivalence (RSABE) approach, and to investigate the pharmacokinetic (PK) properties of Abiraterone in healthy Chinese subjects. This single-dose, open, randomized, four-way replicate study was conducted in healthy Chinese male volunteers under fasted (n=40) and fed (n=40) conditions. Blood samples were collected over a 72h period. Abiraterone concentrations were assayed using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Abiraterone plasma Cmax, AUC0–t and AUC0-∞ were used to assess bioequivalence. Results showed that the 90% CIs for ratios of lnCmax, lnAUC0–t and lnAUC0-∞ for fasted study were 90.14-114.11, 93.96-115.07 and 93.72-113.331, respectively. For fed study, these data were 81.83-102.51, 91.51- 104.89 and 91.46-104.58, respectively. All of the 90% CIs were within the RSABE acceptance limits of the Chinese Food and Drug Administration(CFDA). Food intake increased the systemic exposure and Cmax to Abiraterone by 3-fold and 7-fold, respectively. The Swr of Cmax and AUC0-t for fasted study were 0.445 and 0.389. For fed study, these data were 0.444 and 0.281. The test and reference formulations of abiraterone met the regulatory criteria for bioequivalence of the CFDA. Abiraterone was safe and well tolerated at 250mg dose tested under fasted and fed condition.