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Biologies stability tests

GL17 Stability Biotechnologicals/ biologicals Stability testing of new biotechnological/bio-logical products... [Pg.132]

Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products... [Pg.60]

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 tests on finished dosage forms and products Tests for conformance to pharmacopeial standards Exploratory studies on viruses and cell biology Tests of functionality and/or appropriateness of food additives... [Pg.39]

Q5C Stability testing of biotechnological/biological products (annex to Q1A)... [Pg.865]

Ad Hoc Working Party on Biotechnology/Pharmacy Note For Guid- j ance, Stability Testing of Biotechnolgical/Biological Products, ECC,, III/3772/92-EN, June 1993. [Pg.14]

International Conference on Harmonization (1996). Final Guidelines on Stability Testing of Biotechnological/Biological Products. Federal Register 61, 36465-36469. [Pg.65]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q5C Quality of biotechnological products Stability testing of biotechnological/biological products, Nov. 30,1995. [Pg.29]

Real time stability tests based upon the identity tests for the active ingredient(s), physio-chemical and biological tests nota aggregation, degradation, modifications etc.I Stability of product after reconstitution tests under stress, e.g. heat, light, humidity. [Pg.139]

Guidelines on stability testing of biotechnological/biological products. [Pg.272]

Guidelines on stability testing for biotechnological/biological products (Notification No. 6 of the PAB, 1998). [Pg.290]

See other pages where Biologies stability tests is mentioned: [Pg.159]    [Pg.172]    [Pg.134]    [Pg.337]    [Pg.338]    [Pg.79]    [Pg.554]    [Pg.658]    [Pg.699]    [Pg.16]    [Pg.8]    [Pg.524]    [Pg.534]    [Pg.617]    [Pg.196]    [Pg.362]    [Pg.362]    [Pg.370]    [Pg.38]    [Pg.9]    [Pg.171]    [Pg.57]    [Pg.93]    [Pg.308]    [Pg.1685]    [Pg.1686]    [Pg.1686]    [Pg.135]    [Pg.194]    [Pg.206]    [Pg.345]    [Pg.158]    [Pg.28]   
See also in sourсe #XX -- [ Pg.362 ]



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