Concepedia

Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA

Qing Liu, Barbara M. Davit, Svetlana A. Cherstniakova, Suman Dandamudi, Johnetta F. Walters, Christina H. Lee, Kimberly Raines, Ke Ren, Leeh N. Williamson, Dale P. Conner

The AAPS Journal · 2011 · 20 citations · 0 references

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Concepts

PharmacyPharmacokineticsPharmacologyBioavailabilityBioequivalencePharmacokinetic VariabilityBioequivalence Acceptance CriteriaBioequivalence AssessmentBioequivalence RequirementsNew Drug ApplicationsRegulatory Documentation For BioequivalenceStatistical Analysis Of BioequivalenceHighly Variable Drug BioequivalencePharmacokinetic Bioequivalence AssessmentPost-approval BioequivalenceQuality-by-design For BioequivalenceRegulatory Bioequivalence CriteriaSupplemental New Drug ApplicationsVariability-adjusted Bioequivalence