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Biologic applications, site-specific stability

I. Site-Specific Stability Data for Drug and Biologic Applications... [Pg.48]

Application of prodrugs has involved (1) enhancement of bioavailability and passage through various biological barriers, (2) increased duration of pharmacological effects, (3) increased site-specificity, (4) decreased toxicity and adverse reactions, (5) improvement of organoleptic properties and (6) improvement of stability and solubility properties.184... [Pg.25]

A drug substance should be adequately characterized (i.e., results of chemical, physical, and, when applicable, biological testing). Material produced at different sites should be of comparable quality. In general, 3 to 6 months of stability data on one to three site-specific drug substance batches, depending on the availability of sufficient primary stability data from another site, should be provided at the time of application submission. [Pg.49]

See other pages where Biologic applications, site-specific stability is mentioned: [Pg.80]    [Pg.642]    [Pg.2473]    [Pg.2454]    [Pg.770]    [Pg.728]    [Pg.341]    [Pg.173]    [Pg.209]    [Pg.1271]    [Pg.376]    [Pg.185]    [Pg.200]    [Pg.408]    [Pg.999]    [Pg.155]    [Pg.283]    [Pg.152]    [Pg.222]    [Pg.148]    [Pg.882]    [Pg.695]    [Pg.357]    [Pg.358]    [Pg.352]    [Pg.361]    [Pg.1367]    [Pg.1376]    [Pg.120]    [Pg.83]    [Pg.181]    [Pg.224]    [Pg.1358]    [Pg.249]   


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Applications stabilizers

Biological applications

Biological specific

Biological stability

Biological stabilization

Biology, applications

Site specificity

Specific applications

Specification stability

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