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Stability testing bracketing design

Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products... [Pg.60]

ICH QID Bracketing and matrixing designs for stability testing of drug substances and drug products Step 5 (2002)... [Pg.554]

During the design of stability studies, bracketing and matrixing [10] may be used to achieve reduced testing while at the same time generating enough stability data for evaluation of shelf life. [Pg.568]

Bracketing [ICH Q1A] — Design of a stability schedule so that at any time point only the samples on the extremes, for example, of container size or dosage strengths, are tested. The design assumes that the stability of the intermediate condition samples is represented by those at the extremes. [Pg.65]

International Conference on Harmonization (2002) QID Bracketing and matrixing designs for stability testing of drug substances and drug products EU adopted by CPMP, February 2002, CPMP/ICH/4104/00 MHLW adopted on July 31, 2002 as PFSB/ELD notification No. [Pg.40]

TABLE 5 Testing Schedule for Bracketing Stability Study Design... [Pg.594]

See other pages where Stability testing bracketing design is mentioned: [Pg.315]    [Pg.562]    [Pg.561]    [Pg.568]    [Pg.584]    [Pg.592]    [Pg.639]    [Pg.698]    [Pg.14]    [Pg.39]    [Pg.451]    [Pg.477]    [Pg.524]    [Pg.420]    [Pg.315]    [Pg.226]    [Pg.46]    [Pg.25]    [Pg.105]    [Pg.106]    [Pg.106]    [Pg.315]    [Pg.316]    [Pg.352]    [Pg.17]    [Pg.490]    [Pg.497]    [Pg.504]    [Pg.555]    [Pg.170]    [Pg.343]    [Pg.343]    [Pg.344]    [Pg.568]   
See also in sourсe #XX -- [ Pg.46 ]



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