This report is entirely based on the analysis of a synoptic drug, which is unnamed, but in the attached document ‘synoptic drug’ is 8 sheets in an excel file. It will be nice to include graphs and some tables from the attached documents. Report 1 (1000 words), your report should include: Introduction (10 marks) What is the medical need the medicinal product addresses? You might want to build your business case in this section. Physicochemical properties of the drug substance (40 marks) Structure (NMR, proton is provided, carbon should be predicted) Existence/consequence of chiral centres, pKa values Solubility in solvents Chemical Stability Mass Spectrometry Sample concentration analysis Quality of product (25 marks) How has the identity of the manufactured product been confirmed? How have the level of impurities been confirmed? How has the stability (shelf life) of the medicinal product been confirmed? (This is distinct from the chemical stability of the drug). Has any special packaging been used or have any preservatives been included in the formulation to ensure stability? Pharmacodynamics (25 marks) Mechanism of action: “How the drug works?” – include evidence from in vitro studies. Quantitative analysis of the data provided, including graphs and tables as appropriate. Demonstration of activity using in vivo animal models of the disease.
