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Process evaluation performing side studies

During phase III the analytical laboratory performs systematic methods validation and continues with product characterization. A suitable formulation or a formulation candidate is in place and testing for stability continues. Production evaluates the consistency of the manufacturing process, which should be at a scale capable of delivering commercial quantities. Advanced studies are continued or initiated to evaluate chronic toxicology and reproductive side effects in animal models. Parallel to phase III studies, preparations are made for the submission of the BLA. [Pg.12]

See other pages where Process evaluation performing side studies is mentioned: [Pg.71]    [Pg.674]    [Pg.461]    [Pg.791]    [Pg.93]    [Pg.213]    [Pg.301]    [Pg.73]    [Pg.140]    [Pg.180]    [Pg.1065]    [Pg.173]    [Pg.176]    [Pg.573]    [Pg.68]    [Pg.95]    [Pg.14]    [Pg.110]    [Pg.93]    [Pg.8]    [Pg.187]    [Pg.172]    [Pg.13]    [Pg.481]    [Pg.774]    [Pg.14]    [Pg.466]    [Pg.646]    [Pg.31]    [Pg.646]    [Pg.556]   
See also in sourсe #XX -- [ Pg.19 , Pg.248 ]



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