6533b851fe1ef96bd12a9a93
RESEARCH PRODUCT
Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy.
Peter LangguthHans LennernäsLawrence X. YuGordon L. AmidonKevin S Amidonsubject
Pharmacologybusiness.industryBiopharmaceuticsPublic policyAdministration OralBioequivalencePharmacologyBiopharmaceutics Classification SystemhumanitiesArticleBiopharmaceuticsPolicyRisk analysis (engineering)Pharmaceutical PreparationsTherapeutic EquivalencyInnovatorGeneric drugMedicineDrugs GenericHumansPharmacology (medical)Product (category theory)Product standardbusinessdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2011-07-20 | Clinical pharmacology and therapeutics |