Jamilah Alnahdi 1
1 Saudi Food and Drug Authority (Riyadh, Saudi Arabia), 2 College of pharmacy, King Saud University (Riyadh, Saudi Arabia)
Title: Model-Informed Drug Development at Sِaudi FDA: Approaches, Applications, and Regulatory Impact
Author: Alanood Alkhaldi (1), Jamilah Alnahdi(1), Abdullah Alsultan(2), Albatool Binajlan(1), Naif Al-Taweel(1), Malak Al-Mofada(1), Abdulmohsen Bahlewa(1), Mohammed AlHarbi(1), Jahad Alghamdi(1)
Institution:
(1) Saudi Food and Drug Authority
(2) college of pharmacy, King Saud University
Introduction:
Over the past three decades, the role of Model-informed drug development (MIDD) have become integral during drug development. Over the past few years, the Saudi Food and Drug Authority (SFDA) has started incorporating MIDD in its drug evaluation process. Pharmacometric modeling is increasingly used to characterize drug exposure, variability, and dose-response, enabling optimized dosing strategies and supporting evidence-based development.
Objective:
This study describes the types and roles of modeling used in regulatory submission to the SFDA during 2019.
Methods: All drug submissions, either New Drug Applications (NDAs) or new biologic license applications (BLA) received by the SFDA in 2019 were reviewed.
Method:
For each submission, the type of model used, purpose of modeling, therapeutic area, and clinical data sources were recorded.
Results:
In 2019, the Saudi Food and Drug Authority (SFDA) received 144 total regulatory submissions 38 (26.4%) of them included MIDD components. Population pharmacokinetics (PopPK) dominated, representing 94.4% of submitted models, while Physiologically-Based Pharmacokinetic (PBPK) modeling accounted for 5.6%. Most models (63.0%) integrated data from multiple clinical phases. Their purposes included pharmacokinetic characterization, covariate analysis, exposure–response evaluation, dose optimization, and assessment in special populations. Notably, many PopPK models served multiple overlapping purposes, with covariate analysis often guiding dose adjustments across patient subgroups. Orphan drugs accounted for 55.3% (n=21) of the submissions. Therapeutic area analysis showed that antineoplastic and immunomodulating agents represented the largest category (53.7%, n=29).
Conclusion:
The predominance of PopPK modeling in SFDA submissions underscores its central role in regulatory evaluations. Its use in pharmacokinetic characterization and covariate analysis supports individualized dosing and addresses key regulatory priorities, such as dose justification, benefit–risk assessment, and adjustments in special populations. More broadly, MIDD can streamline clinical trials, enhance efficiency, and improve approval prospects. Also, underscoring MIDD as a critical driver of regulatory submissions, particularly in rare diseases and pediatrics which provide a strong foundation for shaping policies and building capacity to accelerate MIDD integration in regulatory science.
Reference: PAGE 34 (2026) Abstr 12312 [www.page-meeting.org/?abstract=12312]
Poster: Methodology - Other topics