Module 3 2019

Compound Screening

➢ Limited number of characterisations

− Limited quantities of the compounds are available − Large number of compounds to test in a short period

e.g. chemical libraries in FBLD

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➢ Typical studies performed during early development:

Enantiomeric composition

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− Partition coefficients at selected pH − Estimated dissociation constant − Solubility at selected pH − Preliminary stability

Nomenclature and Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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