 | H.W. Rossmoore - 1994 - 454 lapas
...protocol does not only exist in the pharmaceutical sector but also in the cosmetic one. In the former, the International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH 2) pursues the aim to achieve a single standard which will be applied in the registration of pharmaceutical... | |
 | International Validation Forum - 1996 - 860 lapas
...Research (CDER), CBER, and the National Center for Toxicological Research (NCTR) actively participate in the International Conference on Harmonisation of Technical...Registration of Pharmaceuticals for Human Use (ICH). This ongoing project, begun in 1989, has bcen undertaken by governmental agencies responsible for regulation... | |
 | R. Baird, Sally F. Bloomfield - 1996 - 284 lapas
...Teller equation. J. Am. Chem. Soc. 68686-691. ANON. (1993a) British Pharmacopoeia. HMSO, London. (1993b) International conference on harmonisation of technical...for registration of Pharmaceuticals for human use. Orlando, FL: The tripartite guideline for the stability testing of new drug substances and products.... | |
 | Ronald D. Hood - 1996 - 794 lapas
...Toxicity to Male Fertility." This draft guideline was prepared under the auspices of the lnternational Conference on Harmonisation of Technical Requirements...for Registration of Pharmaceuticals for Human Use (lCH). The draft guideline is intended to reflect sound scientific principles for reproductive toxicity... | |
 | Cheng Yee Lowe - 1998 - 286 lapas
...56, 132, 134 insert. See package leaflet(s) inspections, 41. 140, 142-143 intermediate product, 19 International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use. 229, 237-238 conferences of, 238 consultation procedure, 240-241 Expert Working Groups, 239 guidelines... | |
 | Kerry ten Kate, Sarah A. Laird - 1999 - 201 lapas
...(Philippines) International Agricultural Research Centre International Cooperative Biodiversity Group International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use International Crops Research Institute for the Semi-Arid Tropics Institute fur Demoskopie Allensbach... | |
 | José Luis Valverde, G. N. Fracchia - 1999 - 108 lapas
...African Medicines Regulatory Agencies Conference SICA. Secretaria de Integracion Centro Americana ICH, International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use (1990-) representatives of the pharmaceutical industry and other interested parties worldwide. Subsequently,... | |
 | Maurizio Ferrera, Martin Rhodes - 2000 - 320 lapas
...emerged as a key negotiator. Thus, one purpose of EU participation (with the United States and Japan) in the International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use is to help harmonise the technical requirements for registering new medicines.5" This initiative must... | |
 | John Abraham, Graham Lewis - 2000 - 260 lapas
...Accounting Office (US) GATT General Agreement on Tariffs and Trade HAI Health Action International ICH International Conference on Harmonisation of Technical...for Registration of Pharmaceuticals for Human Use IFPIA International Federation of Pharmaceutical Industry Associations ISDB International Society of... | |
 | Teris A vanBeek - 2000 - 565 lapas
...Structure and contents of clinical study reports. ICH-Efficacy Topic 3. Paper presented at the Third International Conference on Harmonisation of technical...for registration of pharmaceuticals for human use, Yokohama, November 28, 1995. Ihl, R., Dierks, T., Martin, E., Frolich, L., Maurer, K. (1992) Ginkgo... | |
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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use... 
