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Excipients probe stability

A. Formulation Development Stability of New Excipients Probe Stability... [Pg.445]

Stability studies are required to run for a longer duration in support of phase II clinical studies. During this phase, the technical focus shifts to development of a commercially viable formulation. In this regard, excipient compatibility studies, multiple formulations, and packaging materials are generally screened. In most cases, short-term (6-month maximum) probe stability data are sufficient, followed by longer term (2-3 years) studies for the selection of the best formulation candidate. The API should also be monitored for stability with studies lasting up to 5 years in duration. [Pg.462]

See other pages where Excipients probe stability is mentioned: [Pg.110]    [Pg.447]    [Pg.461]    [Pg.462]    [Pg.473]    [Pg.479]    [Pg.491]    [Pg.305]    [Pg.497]    [Pg.640]    [Pg.465]    [Pg.337]    [Pg.271]    [Pg.421]    [Pg.450]    [Pg.469]   
See also in sourсe #XX -- [ Pg.461 ]

See also in sourсe #XX -- [ Pg.479 ]



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