Role of Real-World Evidence in Post-Marketing Surveillance of Complex Formulations
Keywords:
Real-world evidence, post-marketing surveillance, complex formulations, pharmacovigilance, regulatory decision-making, electronic health records, patient safety, adverse event detectionAbstract
Post-marketing surveillance (PMS) of complex formulations presents significant challenges dueto their unique pharmacokinetic properties and diverse patient populations encountered in realworld clinical settings. Traditional pharmacovigilance approaches often fail to capture the nuancedsafety profiles of modified-release tablets, combination products, and novel drug delivery systems,creating critical knowledge gaps in drug safety monitoring
References
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Khosla, S., White, R., Medina, J., et al. (2023). Real-world evidence: A primer. PMC, 9815890. https://pmc.ncbi.nlm.nih.gov/articles/PMC9815890/
