Module 3 Presentations

14/05/2024

A Question on Drug Purity

 Batch A Potency 99.9 area % Individual related

 Batch B Potency 97.5 area % Individual related substances

substances < 0.05 area % each Total related substances < 0.05 area % 1 0.8 area % 2 1.5 area % 3 0.5 area % Others 0.1 – 0.3 area % Batch B gives better exposure to potential impurities - qualification

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Phase I Clinical Studies

 Limited quantities of drug needed  Synthesis cost (£ per gram) is a relatively minor consideration o More important to get supplies for clinic to make go/no-go decision o Probably will not use commercial synthesis  Simple formulation(s) and small batch sizes o Drug substance in capsule o Isotonic aqueous solution for injection

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