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Drug Substance Characterization

Development activities encompass drug substance characterization, formulation design, packaging selection, and process development for manufacturing. Each of these aspects influence the lyophilization process. For a drug substance, upstream processing and quality aspects of the starting material need to be quantified. These quality aspects include both assay and purity. In particular, levels of... [Pg.347]

List of all applicable reports supporting drug substance characterization (e.g., certificates of analysis, validation reports, raw material specification, justification report for drug substance, other technical reports). [Pg.479]

Discovery organic, pharmacology Drug substance characterization, salt selection, thin layer chromatography, preparative and analytical LC ... [Pg.2721]

See other pages where Drug Substance Characterization is mentioned: [Pg.615]    [Pg.206]    [Pg.332]    [Pg.332]    [Pg.479]    [Pg.287]    [Pg.289]    [Pg.291]    [Pg.293]    [Pg.295]    [Pg.297]    [Pg.299]    [Pg.301]    [Pg.303]    [Pg.305]    [Pg.307]    [Pg.309]    [Pg.311]    [Pg.313]    [Pg.315]    [Pg.317]    [Pg.319]    [Pg.321]    [Pg.325]    [Pg.327]    [Pg.514]    [Pg.374]   


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