Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy
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The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard. Clinical Pharmacology & Therapeutics (2011) 90 3, 467–470. doi:10.1038/clpt.2011.109
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Demonstrating that two drug formulations/products are bioequivalent is an essential drug approval requirement for both innovator and generic drug products.
“Ability to waive in vivo BE requirements using the BCS biowaiver approach can be pivotal to a successful regulatory submission, because demonstrating that two drug formulations/products are bioequivalent is an essential drug approval requirement for both innovator and generic drug products (7).”
From BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements (2016) · cites this paper as [7]
Ability to waive in vivo BE requirements using the BCS biowaiver approach can be pivotal to a successful regulatory submission.
“Ability to waive in vivo BE requirements using the BCS biowaiver approach can be pivotal to a successful regulatory submission, because demonstrating that two drug formulations/products are bioequivalent is an essential drug approval requirement for both innovator and generic drug products (7).”
From BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements (2016) · cites this paper as [7]
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- Authors
- Amidon, K. S., Langguth, P., Lennernäs, H., Yu, L., & Amidon, G. L.
- Affiliations
- Iowa State University (US)
- Johannes Gutenberg University Mainz (DE)
- Uppsala University (SE)
- United States Food and Drug Administration (US)
- University of Michigan (US)
- Corresponding author
- Amidon, G L
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2011-07-20
- Volume
- 90
- Issue
- 3
- Pages
- 467-470
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- PMC
- PMC3228645
- OpenAlex
- W2019879138
- Cited by
- 44
- References
- 19
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 2 · 2022: 2 · 2021: 2 · 2020: 4 · 2018: 2 · 2017: 2 · 2016: 5 · 2015: 4 · 2014: 6 · 2013: 9 · 2012: 2
- FWCI
- 3.33
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Iowa State University Digital Repository (Iowa State University) (submittedVersion)
- Deep Blue (University of Michigan) (submittedVersion)
- Funders
- Foundation for the National Institutes of Health
- Alexander von Humboldt-Stiftung
- National Institute of General Medical Sciences (R01GM037188, GM 037188)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- bioequivalence, Biopharmaceutics Classification System, generic drugs, immediate release solid oral dosage forms, drug regulation, public policy
- MeSH terms
- Administration, Oral, Biopharmaceutics, Pharmaceutical Preparations, Humans, Therapeutic Equivalency, Drugs, Generic, Policy
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