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VOL. 9, ISSUE 1 (2024)
Biopharmaceutic risk assessment in drug development
Authors
Maciej Leszek RomanowskiL Eszek, Leszek Szmygin
Abstract
The development of new pharmaceuticals is fraught with complexities and
challenges, particularly in ensuring drug efficacy and safety while navigating
the stringent regulatory landscape. Biopharmaceutic risk assessment plays a
pivotal role in this process, offering a structured approach to evaluating how
a drug's physical and chemical properties, alongside its formulation and
delivery mechanism, influence its performance and safety profile. This review
explores the integration of biopharmaceutic considerations into the drug
development risk assessment process, underscoring the importance of early
identification and management of risks related to absorption, distribution,
metabolism, and excretion (ADME) processes. Through a comprehensive analysis of
current methodologies, regulatory guidelines, and case studies, this paper
highlights the strategic importance of biopharmaceutic risk assessment in
optimizing drug design, formulation, and delivery. The discussion extends to
technological advances and emerging trends that hold the promise of enhancing
the precision and efficiency of biopharmaceutic risk assessments, thereby
accelerating the development of safer and more effective drugs. The review
concludes by identifying research gaps and outlining future directions that
could further integrate biopharmaceutics into a holistic drug development
strategy.
Pages:34-36
How to cite this article:
Maciej Leszek RomanowskiL Eszek, Leszek Szmygin "Biopharmaceutic risk assessment in drug development". International Journal of Pharmaceutical Science and Research, Vol 9, Issue 1, 2024, Pages 34-36
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