Concepedia

Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

Barbara M. Davit, Dale P. Conner, Beth Fabian-Fritsch, Sam Haidar, Xiaojian Jiang, Devvrat T. Patel, Paul Seo, Keri Suh, Christina L. Thompson, Lawrence X. Yu

The AAPS Journal · 2008 · 129 citations · 2 references

Open access

Concepts

PharmacyPharmacokineticsPharmacologyBioavailabilityBioequivalencePharmacokinetic VariabilityBioequivalence AssessmentBioequivalence RequirementsBioequivalence Study DesignDrug DispositionGeneric Drug EvaluationHighly Variable Drug ProductsBioequivalence Variability AssessmentGeneric Drug ApplicationsGeneric Drug Approval CriteriaHigh-variability DrugsHighly Variable Drug BioequivalenceHighly Variable DrugsVariability-adjusted Bioequivalence

References

2

Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products

László Tóthfalusi, László Endrényi · Pharmaceutical Research · 2003 · 64 citations

Pharmacy, Pharmacokinetics, Pharmacology +16

Evaluation of Bioequivalence of Highly Variable Drugs Using Clinical Trial Simulations. II: Comparison of Single and Multiple-Dose Trials Using AUC and Cmax

Ahmed El‐Tahtawy, Thomas N. Tozer, Ferrin Harrison et al. · Pharmaceutical Research · 1998 · 33 citations

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +16