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Stability testing for new dosage forms

Stability Testing of New Drug Substances and Products Stability Testing Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms... [Pg.60]

QIC Stability Testing for New Dosage Forms Extends main stability guideline for new formulations of already approved medicines and defines circumstances under which reduced stability data can be accepted... [Pg.698]

Stability Testing for New Dosage Forms Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products... [Pg.641]

Stability testing for new dosage forms. ICH Guideline QIC. Details as in reference 1. [Pg.412]

QIC Stability Testing for New Dosage Forms. Step 5 The tripartite harmonised ICH guideline was finalised (Step 4) in November 1996. It extends the main stability guideline and defines the circumstances under which reduced stability data can be accepted, at the time of filing an application, in the case of new formulations of already approved medicines. [Pg.482]

ICH Guidance for Industry—QIC Stability Testing of New Dosage Forms, November 1996... [Pg.187]

Stability testing Recommendation based on the availability of a significant body of information on the stability of the drug product that is likely to exist after five years of commercial experience for new moleculai entities, or three years of commercial experience for new dosage forms."... [Pg.334]

QIC Stability Testing Requirements for New Dosage Forms CPMP/ICH/280/95 Step 5... [Pg.761]

QIB Photostability testing of new substances and products QIC Stability testing, requirements for new dosage forms Q1D Bracketing and matrixing designs for stability testing of new... [Pg.450]

See other pages where Stability testing for new dosage forms is mentioned: [Pg.132]    [Pg.554]    [Pg.16]    [Pg.1686]    [Pg.290]    [Pg.292]    [Pg.471]    [Pg.524]    [Pg.24]    [Pg.40]    [Pg.3636]    [Pg.490]    [Pg.555]    [Pg.132]    [Pg.554]    [Pg.16]    [Pg.1686]    [Pg.290]    [Pg.292]    [Pg.471]    [Pg.524]    [Pg.24]    [Pg.40]    [Pg.3636]    [Pg.490]    [Pg.555]    [Pg.561]    [Pg.443]    [Pg.17]    [Pg.243]    [Pg.28]    [Pg.151]    [Pg.42]    [Pg.244]    [Pg.1690]    [Pg.451]    [Pg.321]    [Pg.472]    [Pg.75]    [Pg.223]    [Pg.593]    [Pg.290]    [Pg.356]    [Pg.642]    [Pg.419]    [Pg.61]    [Pg.190]    [Pg.970]    [Pg.971]   
See also in sourсe #XX -- [ Pg.24 , Pg.25 ]



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