ABSTRACT: Pregnant women and children have been underrepresented in clinical studies due to ethical concerns and perceived vulnerabilities. This resulted in a significant gap in knowledge regarding the safety and efficacy of medications for these populations. Maternal and Pediatric PRecision In Therapeutics Knowledge Portal (MPRINT-KP) is designed to provide a comprehensive view of pharmacokinetic, pharmaco-epidemiology, and clinical trial research evidence in maternal and pediatric patient populations. MPRINT-KP Silver was generated upon BioBERT models, due to their supreme performance in classifying pharmacokinetic, pharmaco-epidemiology, and clinical trial papers from PubMed, with an F1-score > 0.91. As of April 1, 2025, MPRINT-KP Silver contains 758,560 clinical pharmacology research papers in maternal and pediatric populations. The landscape analysis revealed a large number of drugs with pharmacology knowledge gaps, which is calculated as the relative frequency of drugs with no or weak (i.e., less than five publications) evidence in each of pharmacokinetic, pharmaco-epidemiology, or clinical trial study type. The highest pharmacotherapy knowledge gaps are in postpartum women, pregnant women, and pediatric patients between 0-12 and 12-18 years of age (51.37%, 32.47%, 25.82%, 32.11%, respectively). Pharmacovigilance analyses were conducted on highly prescribed drugs with limited pharmacology evidence in pediatric patients 0-2 year old and pregnant women using United States Food and Drug Administration Adverse Event Reporting System (FAERS) and MarketScan claims data. A number of new drug-associated adverse drug events (ADEs) were discovered. In pediatric patients, there were crisaborole-associated hemorrhage and moxifloxacin-associated cardiac toxicities. In pregnant women, the analysis revealed terconazole-associated abnormalities of heartbeat; benzonatate-associated depressive and anxiety disorders; buspirone-associated abnormalities of heartbeat; cyclobenzaprine-associated tubulo-interstitial nephritis; and pantoprazole-associated hearing loss and voice and resonance disorders. For the first time, a large-scale landscape analysis of pharmacotherapy knowledge gap in both maternal and pediatric patient populations was conducted and identified new drug associated ADE evidence using real world data.
