The Government Pharmaceutical Organization

Bangkok, Thailand

The Government Pharmaceutical Organization

Bangkok, Thailand
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Pitisuttithum P.,Mahidol University | Boonnak K.,Mahidol University | Chamnanchanunt S.,Mahidol University | Puthavathana P.,Mahidol University | And 15 more authors.
The Lancet Infectious Diseases | Year: 2017

Background: The emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost. Methods: This study was done at the Vaccine Trial Centre at Mahidol University, Bangkok, Thailand and was divided into two parts. Part 1 consisted of a randomised, double-blind, placebo-controlled trial done over 18 months. We randomly assigned (2:1) healthy Thai adults aged 18-49 years with a computer generated randomisation sequence (blocks of six) to receive either two intranasal doses (0·25 mL per nostril) of LAIV H5N2 (101 participants) or placebo (51 participants) 21 days apart. For part 2, an open-label trial was done in which previously vaccinated participants (40 from LAIV H5N2 group and 20 placebo) were given one intramuscular dose (0·5 mL) of H5N1 booster vaccine. Participants, investigators, and site-study workers were blinded from randomisation. Immune responses after subsequent immunisation were evaluated using haemagglutination-inhibition and microneutralisation assays and circulating follicular T-helper cells and plasmablast cells were measured in serum and whole blood. The trials are registered with, numbers NCT01841918 and NCT02229357. Findings: Between Feb 4, 2013, and Feb 28, 2013, 256 individuals were screened, of whom 152 participants were enrolled in part 1 of this study. LAIV H5N2 vaccine was well tolerated. Viral shedding was detected in only six (6%) of 101 participants in the vaccine group 1 day after the first vaccination and in and two (2%) of 98 participants in the group after the second vaccination. There was no serious adverse event in both groups. 51 (50%) of 101 participants in the vaccine group and 28 (55%) of 51 in the placebo group reported at least one adverse event. 80 (84%) of 95 events in the vaccine group and 32 (78%) of 43 events in the placebo groups were reportedly suspected adverse events, probably related to the vaccine; however, most were mild in nature. After two doses of vaccine, 13 (13%) of 100 participants in the vaccine group had an increase in haemagglutination-inhibition titre of more than four-fold and four (4%) of 100 vaccinees developed a rise in neutralisng antibody titre of more than four-fold. 1 year later, after a booster with an inactivated H5N1 vaccine (part 2), 39 (98%) of 40 participants who had previously been vaccinated with LAIV H5N2 had an increase in haemagglutination-inhibition titre of greater than four-fold as early as day 7 compared with three (15%) of 20 participants in the placebo group. Peak geometric mean titre (GMT) for haemagglutination-inhibition antibodies in the previously LAIV H5N2 vaccinated group (566·89 [95% CI 436·97-735·44]) were significantly higher than among those who previously received placebo (25·49 [11·82-54·96]; p<0·0001). The peak GMT by neutralising antibody assay in the H5N2 vaccinated group (1395·85 [1040·79-1872·03]) was also significantly higher than that observed in the placebo group (17·41 [9·05-33·48]; p<0·0001). Importantly, higher cross-reactive haemagglutination-inhibition antibody titres against H5N1 (clades 1,, and 2.3.4) were detected in the LAIV H5N2 experienced group than the naive group (p<0·0001). Interpretation: Our data suggest that LAIV vaccination induces long-lasting memory immune responses. The limitation of this study was that part 2 was designed as a proof-of-concept study by contrast with part 1. Funding: WHO. © 2017 World Health Organization.

Techatanawat I.,The Government Pharmaceutical Organization | Manamuti C.,The Government Pharmaceutical Organization | Vattanarongkup J.,The Government Pharmaceutical Organization | Teerawonganan P.,The Government Pharmaceutical Organization | And 5 more authors.
Thai Journal of Pharmaceutical Sciences | Year: 2014

Abacavir is an antiretroviral drug that can be prescribed in single dose or in fixed-dose combination formulations to make adherence easier. Due to this advantage, a generic product of abacavir of GPO has been developed with lower price and would be benefit for HIV patients. A comparative randomized, single dose, two-way crossover, open-label bioequivalence study of the generic abacavir, Abacavir GPO 300 mg tablets, and the reference, Ziagenavir™ 300 mg tablets, after oral administration to 50 healthy, Thai volunteers under fasting conditions with 7 days washout period was carried out. Blood samples wer e collected at predefined time points up to 12 hours. Plasma concentrations of abacavir were analyzed using a validated liquid chromatography tandem mass spectrometry. Non-compartmental model was used for ph armacokinetic analysis. The mean values (± SD) of pharmacokinetic parameters (test vs. reference) were AUC0 -tlast (7114.645 ± 1701.7843 vs 6878.453 ± 1553.6328, AUC0-8 (7161.443 ± 1713.3557 vs 6923.175 ± 15 66.9145 and Cmax (3238.786 ± 1075.6341 vs 3181.232 ± 1072.4422 ng/mL). The 90 % confidence intervals for the ratios of mean AUC0-tlast, AUC0-8 and Cmax for the test/reference were 103.1 (100.83-105.51), 103.2 (100.84 -105.53) and 101.3 (94.05-109.03), respectively. These values were within the acceptable range of 80.00-125.00. Both the formulations were well tolerated. No clinically significant or serious ADRs were observed. By conclusion, two formulations of abacavir, Abacavir GPO and Ziagenavir‒, were bioequivalent and can be used interchangeably © 2014 Faculty of Pharmaceutical Sciences, Chulalongkorn University. All rights reserved.

Kessomboon N.,Khon Kaen University | Limpananont J.,Chulalongkorn University | Kulsomboon V.,Chulalongkorn University | Maleewong U.,Chulalongkorn University | And 2 more authors.
Southeast Asian Journal of Tropical Medicine and Public Health | Year: 2010

This study assessed the impact of the Thai-US Free Trade Agreement (FTA) on access to medicines in Thailand. We first interpreted the text of the sixth round of Thai-US negotiations in 2006 on intellectual property rights (IPR). The impact was estimated using a macroeconomic model of the impact of changes in IPR. The estimated impact is based on a comparison between the current IPR situation and the proposed changes to IPR. The FTA text involves the period of patent extension from the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS Agreement). The provisions involve the period of patent extension, which have to do with compensation for delays in patent registration and/or drug registration, data exclusivity that would result in a delay in generic drug entry, and the enforcing role of the Thai Food and Drug Administration of patent linkages. As a worst case scenario for this single provision, a 10 year patent extension would be given to compensate for delays in patent registration and/or drug registration. The impact on access to medicine, in the year 2027, would be: 1) A 32% increase in the medicine price index, 2) spending on medicines would increase to approximately USD 11,191 million, (USD1= THB 33.9 on September 2, 2009), and 3) the domestic industry could loss USD 3.3 million. These results suggest there would be a severe restriction on the access to medicines under the TRIPS-Plus proposal. IPR protection of pharmaceuticals per the TRIPS-Plus proposal should be excluded from FTA negotiations.

PubMed | The Government Pharmaceutical Organization
Type: Journal Article | Journal: International journal of cosmetic science | Year: 2012

A UV-spectrophotometric method for the analysis of makeup remover was developed and validated according to ICH guidelines. Three makeup removers for which the main ingredients consisted of vegetable oil (A), mineral oil and silicone (B) and mineral oil and water (C) were sampled in this study. Ethanol was the optimal solvent because it did not interfere with the maximum absorbance of the liquid foundation at 250 nm. The linearity was determined over a range of makeup concentrations from 0.540 to 1.412mgmL (R = 0.9977). The accuracy of this method was determined by analysing low, intermediate and high concentrations of the liquid foundation and gave 78.59-91.57% recoveries with a relative standard deviation of <2% (0.56-1.45%). This result demonstrates the validity and reliability of this method. The reproducibilities were 97.321.79, 88.342.69 and 95.632.94 for preparations A, B and C respectively, which are within the acceptable limits set forth by the ASEAN analytical validation guidelines, which ensure the precision of the method under the same operating conditions over a short time interval and the inter-assay precision within the laboratory. The proposed method is therefore a simple, rapid, accurate, precise and inexpensive technique for the routine analysis of makeup remover efficacy.

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