Learning Outcomes
The use of Bioequivalence as a tool for the assessment of pharmaceuticals. Development of in vitro / in vivo correlations as a tool for the quality control of pharmaceuticals. Statistics for bioequivalence studies.
Laboratory practical: Quality control assays of tablets containing acetaminophen (dissolution studies, analysis of drug content and weight uniformity).
Course Content (Syllabus)
The use of Bioequivalence as a tool for the assessment of pharmaceuticals. Development of in vitro / in vivo correlations as a tool for the quality control of pharmaceuticals. Statistics for bioequivalence studies.
Laboratory practical: Quality control assays of tablets containing acetaminophen (dissolution studies, analysis of drug content and weight uniformity).
Additional bibliography for study
1. Physical Pharmacy Fourth Edition, Ed. Al. Martin Lea & Febiger Philaddelphia, London 1993.
2. Pharmaceutics – the Science of Dosage Form Design, 2nd Edition, Churchill Livingstone, London 2002.
3. Drug Stability: Principles and practices Ed. C. T. Rodes and J.O. Cartensen, Marcel Dekker: New York. 1990.