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General Considerations for Clinical

Studies in support of special populations geriatrics Guidance on General Considerations for Clinical Trials Notice... [Pg.76]

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E8 Note for Guidance on General Considerations for Clinical Trials, CPMP/ICH/291/95. London European Agency for the Evaluation of Medicinal Products, 1997. [Pg.236]

ICHE8 General considerations for clinical trials Step 5 (1997)... [Pg.555]

FDA (1998) Developing Anti-microbial Drugs - General Considerations for Clinical Trials ... [Pg.115]

International Conference on Harmonization E8 (1997) Guidance on General Considerations for Clinical Trials, Food and Drug Administration [Docket No. 97D-0188], December 1997... [Pg.660]

E8 General Considerations for Clinical Trials CPMP/ICH/291/95 Step 5... [Pg.762]

General Considerations for Clinical Trials ICH Harmonized Tripartite Guideline (E8), 1997. [Pg.2507]

General Considerations for Clinical Studies of Food Ingredients... [Pg.2215]

General Considerations for Clinical Trials. International Conference on Harmonization [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1997. http //www.ifpma.org/pdfifjpma/e8.pdf. [Pg.157]

And, including ICH standards, the General Considerations for Clinical Studies (April 1998)... [Pg.500]

ICH Harmonized Tripartite Guideline. General considerations for clinical trials, E8, July 17, 1997. [Pg.70]

International Conference on Harmonization (1997) Draft guideline on general considerations for clinical trials. Fed Reg 62 (104). [Pg.30]

In Europe, the European Commission (EC), through its Directorate General, DG III, responsible for trade including pharmaceuticals, and the Committee for Proprietary Medicinal products (CPMP), issued, on November 20 1996, draft notes for guidance, with a 6 month consultation period, on (a) non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95) and (b) general considerations for clinical trials (CPMP/ICH/291/95). Further revisons are expected. A directive on good clinical practices (GCP) will follow. [Pg.456]

ICH E8 (1997) General considerations for clinical trials. Available at http //www.ich.org/filead-min/Public Web Site/ICH Products/Guidelines/Efficacy/E8/Step4/E8 Guideline.pdf. Accessed 23 Nov 2015... [Pg.98]

See other pages where General Considerations for Clinical is mentioned: [Pg.829]    [Pg.312]    [Pg.141]    [Pg.297]    [Pg.2496]    [Pg.353]    [Pg.398]    [Pg.811]    [Pg.372]    [Pg.374]    [Pg.75]    [Pg.115]   


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