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Dr. Marco DeLuca
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Ensuring Drug Interchangeability: Key Bioequivalence Principles
Bioequivalence studies are critical for demonstrating drug product interchangeability by assessing pharmacokinetic equivalence. Regulatory agencies provide stringent guidelines, often utilizing dissolution testing and statistical analysis. Advances include novel statistical methods and in vitro data. The Biopharmaceutics Classification System (BCS)... Read More»
: Clin Pharmacol Biopharm 14: 567.
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