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Drug substances crystal morphology

By the time the clinical program has entered phase 3, the sponsor should provide a full description of the physical, chemical, and biological characteristics of the drug substance. For example, most of the following should be evaluated and submitted solubility and partition coefficient, pKa, hygroscopicity, crystal properties/morphology, thermal evaluation, X-ray diffraction, particle size, melting point, and specific rotation stereochemical consideration. Proof... [Pg.77]

See other pages where Drug substances crystal morphology is mentioned: [Pg.764]    [Pg.43]    [Pg.249]    [Pg.57]    [Pg.490]    [Pg.348]    [Pg.846]    [Pg.436]    [Pg.3004]    [Pg.76]    [Pg.252]    [Pg.206]    [Pg.74]    [Pg.257]    [Pg.764]    [Pg.41]    [Pg.137]    [Pg.442]    [Pg.192]   
See also in sourсe #XX -- [ Pg.204 ]



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