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International Conference pharmaceuticals

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... [Pg.285]

The International Conference on Harmonisation (ICH) of technical requirements for the registration of pharmaceuticals for human use was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency... [Pg.36]

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. [Pg.131]

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... [Pg.142]

Altvater, M., Rietz, R., Neubeet, R., Micromixer based formation of emulsions and creams for pharmaceutical applications, in Proceedings of the 4th International Conference on Microreaction Technology, IMRET 4, pp. 467 77 (5-9 March 2000), AIChE Topical Conf Proc., Atlanta, USA. [Pg.124]

ICH Expert Working Group, Q1A Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. [Pg.173]

Timing of Non-Clinical Safety Studies for the Conduct of Human Clinical trials for Pharmaceuticals. Fourth International Conference on Harmonization. International Conference on Harmonization, Brussels, 1997. [Pg.476]

In recent years, regulatory authorities and industry associations have undertaken several important initiatives to promote international harmonization of regulatory requirements. These efforts are designed to enhance harmonization and are committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. These efforts are undertaken under the auspices of the International Conference on Harmonization (ICH), which is organized to provide an opportunity for tripartite... [Pg.714]

International Conference on Harmonization, Validation of analytical procedures methodology, step 2. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Yokohama, Japan. Nov. 29-Dec. 1, (1995). [Pg.718]

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, [Internet]. URL http //www.ifp-ma.org/ichl.html, accessed 7-15-2000. [Pg.790]

G. E. Amidon, Mixing and Row, Proceedings of the 31st International Industrial Pharmaceutical Research Conference, University of Wisconsin—Extension, 1989. [Pg.320]

Food and Drug Administration, HHS, International Conference on Harmonisation Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals availability. Notice, Fed. Regist., 71, 19193,2006. [Pg.18]

International Conference on Harmonisation. ICH-S8, Immunotoxicity Studies for Human Pharmaceuticals, 2005. [Pg.360]

Thorsten C,Goldbach H (2003) Determination of antibiotic residues in manure, soil, and surface waters. 3rd international conference on pharmaceuticals and endocrine disrupting chemicals in water. Institute for Hygiene and Public Health, University of Bonn... [Pg.237]

EU (2001) EU directive 2001/83/EC. http //eur-lex.europa.eu/LexUriServ/site/en/consleg/2001/L/ 02001L0083-20070126-en.pdf. Cited 30 Dec 2008 EMEA (2008) European Medicines Agency. EPARs for authorised medicinal products for human use. http //www.emea.europa.eu/htms/human/epar/a.htm. Cited 30 Dec 2008 ICH (2008) The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). http //www.ich.org. Cited 30 Dec 2008 ISMP (2005) The Institute for Safe Medication Practices. List of confused drug names. http //www.ismp.org/Tools/confuseddrugnames.pdf. Cited 30 Dec 2008... [Pg.110]

The International Conferences on Harmonization has published its document S6, Preclincial Safety Evaluation of Biotechnology-Derived Pharmaceuticals. The FDA (the Center for Drug Evaluation and Research, and the Center for Biologies Evaluation and Research jointly) has published the document as a Guidance for Industry (Anon., 1997a, b FDA, 1989, Hayes and Reyffel, 1999). [Pg.49]

S. Stainmesse, A. M. Orecchioni, and E. Nakache, Modelling of an original process to obtain biocompatible polymeric nanospheres, in 1992 6th International Conference on Pharmaceutical Technology, pp. 89-97. [Pg.16]

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