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Stability testing guidelines

Stability test guidelines for new active ingredients implemented. Standards and test method guidelines enforced. [Pg.271]

QIA Revisions to the Stability Testing Guideline were finalised. [Pg.646]

ICH stability testing guidelines are available on the Internet, see Table 2, and there is a process by which they are introduced eventually into official status in the USA, EEC, and Japan. [Pg.3635]

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... [Pg.284]

Before undertaking a discussion of the mathematics involved in the determination of reaction rates is undertaken, it is necessary to point out the importance of proper data acquisition in stability testing. Applications of rate equations and predictions are meaningful only if the data utilized in such processes are collected using valid statistical and analytical procedures. It is beyond the scope of this chapter to discuss the proper statistical treatments and analytical techniques that should be used in a stability study. Some perspectives in these areas can be obtained by reading the comprehensive review by Meites [84], the paper by P. Wessels et al. [85], and the section on statistical considerations in the stability guidelines published by FDA in 1987 [86] and in the more recent Guidance for Industry published in June 1998 [87],... [Pg.154]

Quality of biotechnology products, analysis of the expression construct in cells used for production of r-DNA derived protein product Quality of biotechnological products stability testing of biotechnological/Biology products Availability of Draft Guideline on Quality of... [Pg.76]

Stability Testing of New Drug Substances and Products, ICH Guideline QIA. [Pg.188]

A. Guidelines for Stability Testing on Drug Substances and Drug Products... [Pg.335]

ICH Harmonized Tripartite Guideline—Bracketing and Matrixing Designs for Stability Testing of New Drug Substance and Products QID, 2002. [Pg.358]

Stability Testing of New Drugs and Products (Revised guideline), International Council on Harmonisation, http //www.ich.org/UrlGrpServer.jser ID=363 QlA(R2). [Pg.377]

ICH Q1 A(R2) Stability testing of new drugs and products (revised guideline) Step 5 (2003)... [Pg.554]

Grimm W. (1998), Extension of International Conference on Harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones III and IV, Drug Dev. Ind. Pharm., 24,313-325. [Pg.582]

International Conference on Harmonization (ICH) Steering Committee (1994), ICH harmonized tripartite guideline, Stability testing of new drug substances and products, ICH, Geneva. [Pg.676]

See other pages where Stability testing guidelines is mentioned: [Pg.4102]    [Pg.498]    [Pg.183]    [Pg.190]    [Pg.316]    [Pg.804]    [Pg.4102]    [Pg.498]    [Pg.183]    [Pg.190]    [Pg.316]    [Pg.804]    [Pg.40]    [Pg.212]    [Pg.160]    [Pg.167]    [Pg.168]    [Pg.156]    [Pg.27]    [Pg.164]    [Pg.309]    [Pg.3]    [Pg.9]    [Pg.134]    [Pg.335]    [Pg.342]    [Pg.357]    [Pg.675]    [Pg.69]    [Pg.122]    [Pg.154]    [Pg.154]    [Pg.155]    [Pg.561]    [Pg.561]    [Pg.584]    [Pg.642]    [Pg.648]    [Pg.658]   
See also in sourсe #XX -- [ Pg.22 , Pg.23 , Pg.24 ]



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Stability testing

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