Quality Assurance of Drugs & Medicinal Products

Principles of good laboratory practice: Drug quality assurance system: Monographs and specification for drugs and drug products. Stability studies, Basic tests methodology for essential drugs

Analysis of drugs in biological samples. Applications of chemical and physicochemical analytical methods in purity determinations identification of pharmaceuticals, radio-pharmaceuticals and medicinal products; biopharmaceutical methods in purity determination.

Biopharmaceutical/Equivalency: Definition of key concepts-Generics, trademarks, innovators. BCS classifications. Pharmaceutical alternatives. Therapeutics Equivalency, Chemical Equivalence and Bioavailability/bioequivalence of drug products. Other Instrumental Methods; e.g. Fluorimetry; Polarimetry; Polarography, Potentiometry. Practical applications of some quality assurance procedures in drug quality control, identifications and standardization, and instrumental analysis of pharmaceuticals, which include: Determination of mixture containing borax and boric acid; Determination of the percentage of sodium salicylate and acetyl salicylic acid (Aspirin); Ultra-violet and visible spectrophotometry; NMR and MS spectra interpretation; Assay of calcium lactate tablet; Assay of sodium chloride in Dextrose/Saline. Chemical and bioequivalence tests of the APIs of branded products and generics for purpose of quality control and drug substitution.