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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