Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 4 de 4
Filtrar
Mais filtros

Base de dados
Tipo de documento
Intervalo de ano de publicação
1.
BMC Med Res Methodol ; 24(1): 82, 2024 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-38580928

RESUMO

BACKGROUND: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017. METHODS: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence. RESULTS: A total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%]). CONCLUSION: This comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia.


Assuntos
Medicamentos Genéricos , Humanos , Equivalência Terapêutica , Medicamentos Genéricos/uso terapêutico , Arábia Saudita , Estudos Retrospectivos , Tamanho da Amostra
2.
Ther Innov Regul Sci ; 58(4): 730-745, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38600418

RESUMO

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process. The objective of this research is to examine and document the shared encounters involving remote inspections and evaluations carried out by SFDA from 2020 to 2022. This will be achieved through the evaluation of the accuracy of document evaluation and the extent to which the objectives of smart GxP inspections were met. Data were collected from local and international smart inspections reports conducted by SFDA between 2020 and 2022, covering medical device manufacturers, pharmaceutical manufacturing sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The results indicate that smart GxP inspections were effective in achieving visit objectives, showing a high degree of document evaluation accuracy. The findings of this study support the use of smart GxP inspections as a valuable alternative to on-site inspections, offering a practical solution to regulatory compliance during the pandemic and beyond. Although the SFDA recognizes the usefulness of smart inspections in upholding regulatory oversight in the face of various challenges, it does not endorse the complete replacement of conventional on-site inspection methods. The SFDA acknowledges significant limitations associated with the current technological resources used in remote regulatory assessments, and these limitations will be explored in the relevant sections.


Assuntos
COVID-19 , United States Food and Drug Administration , Arábia Saudita , Humanos , Estados Unidos , SARS-CoV-2 , Pandemias
3.
J Pharm Policy Pract ; 16(1): 91, 2023 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-37464406

RESUMO

BACKGROUND: Previous studies have suggested that drug pricing could contribute to drug shortages; however, there is limited quantitative assessment of this potential causal association. This retrospective database analysis aimed to investigate the association between drug prices and drug shortage incidents in Saudi Arabia. METHODS: This was a retrospective database analysis study. Drugs with shortage notifications sent to the Saudi Food and Drug Authority (SFDA) between January 2017 and December 2020 were included. Each drug's foreign-to-Saudi price ratio (FTSPR) was calculated by dividing the mean international price by the Saudi price. Drugs were categorized into three groups based on their FTSPR: Group 1 (FTSPR > 1), Group 2 (FTSPR = 1), and Group 3 (FTSPR < 1). The primary outcome was the ratio of mean counts (mCR) between the three groups, with Group 3 serving as the control group. The analysis was adjusted for the measured confounders using a negative binomial regression model. RESULTS: A total of 900 drugs were included in the study, with 348 in Group 1, 345 in Group 2, and 209 in Group 3. The mean count in Group 1 was higher compared to Group 3 (mCR: 1.88; 95% confidence interval [CI] 1.24 to 2.83), while the mean counts between Group 2 and Group 3 were comparable (mCR: 1.39; 95% CI 0.92 to 2.09). CONCLUSIONS: Our findings indicate an association between drug shortage incidents and higher prices of drugs outside Saudi Arabia. Further studies are needed to explore this causal relationship in different contexts.

4.
Saudi Pharm J ; 30(12): 1725-1735, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36601511

RESUMO

Background: Vaccine adverse event reporting system (VAERS) was established in the United States (U.S.) as an early warning system with a main purpose of collecting post-marketing Adverse events following immunizations (AEFIs) reports to monitor the vaccine safety and to mitigate the risks from vaccines. During the coronavirus diseases 2019 (COVID-19) pandemic, VAERS got more attention as its important role in monitoring the safety of the vaccines. The aim of this study was to investigate VAERS patterns, reported AEFI, vaccines, and impact of different pandemics since its inception. Methods: This was an observational study using VARES data from 2/7/1990 to 12/11/2021. Patterns of reports over years were first described, followed by a comparison of reports statistics per year. Furthermore, a comparison of incidents (death, ER visits, etc.) statistics over years, in addition to statistics of each vaccine were calculated. Moreover, each incident's statistics for each vaccine were calculated and top vaccines were reported. All analyses were conducted using R (Version 1.4.1717) and Excel for Microsoft 365. Results: There were 1,396,280 domestic and 346,210 non-domestic reports during 1990-2021, including 228 vaccines. For both domestic and non-domestic reports, year of 2021 had the highest reporting rate (48.52 % and 70.33 %), in addition a notable change in AEFIs patterns were recorded during 1991, 1998, 2000, 2006, 2009, 2011, and 2017. AEFIs were as follow: deaths (1.00 % and 4.08 %), ER or doctor visits (13.37 % and 2.27 %), hospitalizations (5.84 % and 27.78 %), lethal threat (1.42 % and 4.38 %), and disabilities (1.4 % and 7.96 %). Pyrexia was the top reported symptom during the past 31 years, except for 2021 where headache was the top one. COVID-19 vaccines namely Moderna, Pfizer-Biontech, and Janssen were the top 3 reported vaccines with headache, pyrexia, and fatigue as the top associated AEFIs. Followed by Zoster, Seasonal Influenza, Pneumococcal, and Human papillomavirus vaccines. Conclusions: The large data available in VARES make it a useful tool for detecting and monitoring vaccine AEFIs. However, its usability relies on understating the limitations of this surveillance system, the impact of governmental regulations, availability of vaccines, and public health recommendations on the reporting rate.

SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA