other · 2023

Biopharmaceutics Classification System: Theory and Practice

Mehul Mehta, Jayabharathi Vaidyanathan, Lawrence X. Yu

Cited by 1Abstract and details only

Abstract

This chapter describes the theory and practice of the biopharmaceutics classification system (BCS). The BCS is the concept that was developed to meet regulatory needs. It resulted in the first Food and Drug Administration (FDA) guidance that was entirely based on the results of regulatory-sponsored research. The FDA issued its first BCS guidance in 2000. However, it took 20 years for its acceptance worldwide, as witnessed by the issuing of M9, the ICH BCS guidance. Over the years, we have witnessed how a scientifically fundamental concept involving basic properties of the drug substance and drug product evolved into regulatory guidance, resulting in approval of hundreds of drug applications. By providing appropriate in vitro methods to replace expensive, time-consuming, and avoidable in vivo bioequivalence (BE) studies, the BCS has facilitated availability of good-quality drug products at reduced cost and at a faster pace for benefit of patients globally.

Cite this paper

APA 7

Mehta, M., Vaidyanathan, J., & Yu, L. X. (2023). Biopharmaceutics Classification System: Theory and Practice. https://doi.org/10.1002/9781119660699.ch9

MLA 9

Mehta, Mehul, et al. “Biopharmaceutics Classification System: Theory and Practice.” 2023, pp. 131–40, https://doi.org/10.1002/9781119660699.ch9.

Chicago

Mehta, Mehul, Jayabharathi Vaidyanathan, and Lawrence X. Yu. 2023. “Biopharmaceutics Classification System: Theory and Practice.” https://doi.org/10.1002/9781119660699.ch9.

Harvard

Mehta, M., Vaidyanathan, J. and Yu, L.X. (2023) ‘Biopharmaceutics Classification System: Theory and Practice’. Available at: https://doi.org/10.1002/9781119660699.ch9.

BibTeX

@misc{mehta2023biopharmaceutics,
  title = {{Biopharmaceutics Classification System: Theory and Practice}},
  author = {Mehta, Mehul and Vaidyanathan, Jayabharathi and Yu, Lawrence X.},
  pages = {131--140},
  year = {2023},
  doi = {10.1002/9781119660699.ch9}
}

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