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ICH Harmonized Tripartite Guideline

Vital Safety Evaluation of Biotechnology Products Derived from CeU Liaes of Human or Animal Origin," ICH Harmonized Tripartite Guideline,... [Pg.145]

ICH Harmonized Tripartite Guideline for Good Clinical Practice (Table 6.1 shows the ICH documents related to clinical trials)... [Pg.187]

ICH Harmonized Tripartite Guideline for Good Clinical Practice ... [Pg.189]

ICH Harmonized Tripartite Guideline—Stability Data Package for Registration Applications in Climatic Zones III and IV QIF, 2003. [Pg.358]

ICH Harmonized Tripartite Guideline—Stability Testing of New Drug Substances and Products QIA (R2), 2003. [Pg.358]

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

ICH Harmonized Tripartite Guideline—Evaluation for Stability Data QIE, 2003. [Pg.358]

ICH Harmonized Tripartite Guideline—Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Q6A, 1999. [Pg.358]

ICH, ICH harmonized tripartite guideline Q8(R1), Pharmaceutical development, available http //www.ich.org/LOB/ media/MEDIA4986.pdf accessed 17 November 2009. [Pg.278]

The current ICH harmonized tripartite guideline for genotoxicity testing of pharmaceuticals (S2B) defines a standard battery of tests, including both in vitro... [Pg.253]

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

ICH Harmonized Tripartite Guideline, ICH Q2A, Text on Validation of Analytical Procedures, Mar. 1995. [Pg.26]

ICH Harmonized Tripartite Guideline, ICH Q3B, Impurities in New Drug Products, Oct. 1999. [Pg.26]

ICH Harmonized Tripartite Guideline ICH Q2B, Validation of Analytical Procedures Methodology, May 1997. [Pg.49]

ICH Harmonized Tripartite Guideline, ICH QIC, Stability Testing of New Dosage Forms, Nov. 1996. [Pg.253]

Myres, G. J., The Art of Software Testing, New York Wiley, 1979 ICH. Harmonized tripartite guideline. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH Steering Committee. Nov. 10,2000. [Pg.250]

Specifications Test procedures and Acceptance Criteria for Biotechnological/Bio-logical Products, ICH Harmonized Tripartite Guideline, 1999. [Pg.41]

ICH Harmonized Tripartite Guideline S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. July 1997. http //www.ich.org/LOB/media/ MEDIA503.pdf... [Pg.90]

ICH Harmonized Tripartite Guideline M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. November 2000. http //www. ich.org/LOB/media/MEDIA506.pdf... [Pg.91]

According to the ICH Harmonized Tripartite Guideline, particularly in cases of low or no toxicity, but also in cases of chronic exposure, single and two study designs in rodents are also possible and acceptable. [Pg.846]

ICH Harmonized Tripartite Guideline Detection of toxicity to reproduction for medicinal products, Endorsed by the ICH Steering Committee at step 4 of the ICH process (June 24, 1993)... [Pg.848]

International Organization on Harmonisation (2000), ICH harmonized tripartite guideline Good manufacturing practice guide for active pharmaceutical ingredients, available http //www.ICH.org, accessed June 23,2005. [Pg.200]

See other pages where ICH Harmonized Tripartite Guideline is mentioned: [Pg.305]    [Pg.308]    [Pg.309]    [Pg.164]    [Pg.293]    [Pg.648]    [Pg.882]    [Pg.319]    [Pg.842]    [Pg.196]   


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