Impact of the US FDA “Biopharmaceutics Classification System” (BCS) Guidance on Global Drug Development

Abstract

The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided. Results show that greater than 160 applications were approved, or tentatively approved, based on the BCS approach across multiple therapeutic areas; an additional significant finding was that at least 50% of these approvals were in the central nervous system (CNS) area. These findings indicate a robust utilization of the BCS approach toward reducing unnecessary in vivo BE studies and speeding up availability of high quality pharmaceutical products. The article concludes with a look at the adoption of this framework by regulatory and health policy organizations across the globe, and FDA's current thinking on areas of improvement of this guidance.

Biopharmaceutics Classification System: Evaluation on International Guidelines and Countries

“…Bu da BCS-temelli biyomuafiyetin büyük oranda kabul gördüğünü desteklemektedir. 42 Sonuç olarak, sağlık otoriteleri tarafından biyomuafiyeti kabul edilen ilaçların sayısı her geçen gün artmaktadır ve bu ilaçlar Uluslararası İlaç Federasyonu (FIP) tarafından düzenli olarak değerlendirilerek öneri şeklinde yayımlanmaktadır. 43 WHO ise biyomuafiyet başvurusu için çeşitli formlar yayımlayarak firmaların başvuru işlemlerinde yol gösterici olmaktadır.…”

Excipient-Free Pure Drug Nanoparticles Fabricated by Microfluidic Hydrodynamic Focusing

“…Nanotechnology has made a significant contribution to overcome (bio)pharmaceutical drawbacks of drugs such as poor aqueous solubility, low physicochemical stability in the biological milieu, short half-life and low bioavailability and efficacy [1][2][3][4]. For instance, >60% of the approved small-molecule drugs and~90% of new drugs under development are classified as poorly water-soluble according to the Biopharmaceutics Classification System [5][6][7][8]. These drawbacks challenge the translation of drug candidates into new products, contribute to the high drug attrition rates in pharmaceutical development, and motivate the pharmaceutical industry to seek for non-traditional dosage forms and delivery routes [9][10][11][12][13][14].…”

Norfloxacin Loaded Lipid Polymer Hybrid Nanoparticles for Oral Administration: Fabrication, Characterization, In Silico Modelling and Toxicity Evaluation

“…Limited oral bioavailability represents its hydrophobic nature. This hydrophobic nature exacerbates its global image and thus drives pharmaceutical scientists to place it in Class-IV of the Biopharmaceutical Classification System (BCS-IV), representing low solubility and low permeability [8,9]. Various approaches, such as Solid Dispersion and Cyclodextrin inclusion complexes, have been used to improve the solubility and bioavailability of Norfloxacin [10,11].…”