Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.

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.

Intricate Evaluation of Association between Dental Caries and Obesity among the Children in Al-Kharj City (Saudi Arabia).

INTRODUCTION: Dental caries and obesity are two of the most prevalent health conditions affecting children. Relative decrease in corporeal movements, escalating inactive lifestyles, and changes in dietary factors are strongly linked with the increasing incidence of overweight and obesity. Furthermore, obesity increases the risk of chronic disease and dental caries that significantly affects the quality of life of young children. The present study intends to explore the relationship between dental caries and obesity in children in Al-Kharj city, Kingdom of Saudi Arabia. MATERIALS AND METHODS: The present descriptive study was designed as a cross-sectional study in which a total of 386 children in the age range of 6 to 12 years from elementary schools of Al-Kharj city and pediatric dental clinics in Prince Sattam Dental College were included. RESULTS: Mean decayed filled teeth (DFT) score was found to be considerably higher among obese children. Also, incidence of dental caries in deciduous dentition was found to be notably higher among obese children. CONCLUSION: Obesity has a considerable outcome on prevalence of dental caries among primary schoolchildren in Al-Kharj city, Kingdom of Saudi Arabia. The importance of obesity is limited not only to systemic disorders but also in relation to carious lesions. Hence, educating primary schoolchildren about caries and its related factors is very important. CLINICAL SIGNIFICANCE: High intake of free sugar is a well-established risk factor for dental caries and also for obesity. Therefore, it is speculated that factors that decrease these risk factors have the potential to affect both conditions at the population level to control it competently.