Individual bioequivalence—a regulatory update
Author:
Affiliation:
1. a Division of Pharmaceutical Evaluation II Office of Clinical Pharmacology and Biopharmaceutics , Center for Drug Evaluation and Research Food and Drug Administration , 5600 Fishers Lane, Rockville, Maryland, 20857
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543409708835162
Reference16 articles.
1. The Subject-by-Formulation Interaction as a Criterion of Interchangeability of Drugs
2. Consideration of individual bioequivalence
3. Ekbohm , G. and Melander , H. 1990. “On variation, bioequivalence and interchangeability”. Uppsala: Department of Statistics, Swedish University of Agricultural Sciences. Report 14
4. Bioequivalence revisited
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