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Stability requirements formulation changes

For a change in formulation such as excipients, measured values (except when there are no effects on the standards and test methods), stability test (in cases that the stability after the change is not worse than before, a relative comparative test) and bioequivalence tests are required. [Pg.286]

Determining the shelf-life of a pharmaceutical product can sometimes be the slowest step in the effort to bring a new drug product to the market. This is especially important if stability issues arise requiring a change of formulation or process. Consequently, there is a desire in pharmaceutical corporations to determine the shelf-life... [Pg.124]

See other pages where Stability requirements formulation changes is mentioned: [Pg.299]    [Pg.111]    [Pg.39]    [Pg.104]    [Pg.991]    [Pg.342]    [Pg.93]    [Pg.93]    [Pg.1834]    [Pg.1893]    [Pg.2107]    [Pg.381]    [Pg.464]    [Pg.716]    [Pg.358]    [Pg.104]    [Pg.186]    [Pg.95]    [Pg.112]    [Pg.255]    [Pg.183]    [Pg.117]    [Pg.117]    [Pg.281]    [Pg.462]    [Pg.464]    [Pg.490]    [Pg.288]    [Pg.253]    [Pg.72]    [Pg.299]    [Pg.406]    [Pg.704]    [Pg.467]    [Pg.154]    [Pg.5]    [Pg.36]    [Pg.387]    [Pg.9]    [Pg.157]    [Pg.96]    [Pg.69]    [Pg.587]    [Pg.650]    [Pg.38]    [Pg.54]    [Pg.244]    [Pg.103]   
See also in sourсe #XX -- [ Pg.100 , Pg.101 ]



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