Application of a Post-Marketing Surveillance of Complex Formulations
Keywords:
Post-marketing surveillance, complex formulations, pharmacovigilance, adverse drug reactions, drug safety, regulatory compliance, liposomes, nanoparticles, FAERS, drug withdrawalAbstract
Complex formulations including modified-release tablets, combination products, and novel drugdelivery systems present unique challenges in post-marketing surveillance due to their distinctpharmacokinetic properties and diverse safety profiles. Traditional pharmacovigilance approachesoften fail to adequately monitor these sophisticated therapeutic products, creating critical gaps indrug safety monitoring for real-world patient populations.
References
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Agno Pharmaceuticals. (2018). Complex drug products: Understanding the regulatory landscape. Pharmaceutical Development Review, 15(3), 45-52. https://agnopharma.com/blog/complex-drug-products-regulatory-landscape
