Biotechnological/biological products stability

Testing of Biotechnological/Biological Products. Stability protocols should be... [Pg.354]

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]

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

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]

Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products ICH Harmonized Tripartite Guideline (Q5C), 1995. [Pg.2507]

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]

Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003) Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003) Q5C Quality of Biotechnological Products Stability Testing of Biotechnological/ Biological Products ... [Pg.294]

On the whole, there is no single stability-indicating assay or parameter that profiles the stability characteristics of a biotechnological/biological product. Consequently, the manufacturer should propose a stability-indicating profile that provides assurance that changes in the identity, purity, and potency of the product will be detected. [Pg.374]

The degree of purity, as well as the individual and total amounts of degradation products of the biotechnological/biological product entered into the stability studies, should be reported and documented whenever possible. Limits of acceptable degradation should be derived from the analytical profiles of batches of the DS and DP used in the preclinical and clinical studies. [Pg.374]

Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products (General Chapter 1049), 2004, in United States Pharmacopeia, 27th rev., and National Formulary, 22nd ed., The United States Pharmacopeial Convention, Inc., Rockville, MD, pp. 481 184. [Pg.188]

International conferences on harmonization of technical requirements for registration of pharmaceuticals for human use. In Q5C, ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products Stability Testing Biotechnological/Biological Products. Available at http //www.ich.org. [Pg.509]