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International Conference on Harmonisation of Technical Requirements for

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)... [Pg.312]

ICH Expert Working Group, Q1A (R) Stability Testing of New Drug Substances and Products (draft), International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 2000. [Pg.173]

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]

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]

Quantitative CE—MS studies were scarcely reported. " This subject is however of prime importance, particularly for the pharmaceutical industry where the reliability of analytical data is essential. For this reason, method development is generally followed by an evaluation of quantitative performance using an appropriate validation procedure performed in agreement with criteria established by the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) and the Food and Drug Administraction (FDA) guidelines, or Societe Franqaise des Sciences et Techniques Pharmaceutiques (SFSTP) commissions. ... [Pg.493]

Anon. Text on vahdations of analytical procedures. In International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use, 1994. http //www.ifpma.org/ ich5q.html Analytical. [Pg.108]

International Conference on Harmonisation of technical requirements for the registration of Pharmaceuticals for Human use. ICH guidelines on Male Fertility Studies S5 (R2) November 2005... [Pg.242]

Hypoalgesia ICH (International Conference on Harmonization) Diminished sensitivity to a noxious stimulation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to harmonise scientific and technical aspects of product registration. They make recommendations which will be adopted by the national / EU authorities after an approval process. [Pg.584]


See other pages where International Conference on Harmonisation of Technical Requirements for is mentioned: [Pg.39]    [Pg.306]    [Pg.9]    [Pg.360]    [Pg.1]    [Pg.552]    [Pg.348]    [Pg.355]   


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Conferences on Harmonisation

HARMONISATION

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International Conference Harmonisation

International Conference Requirements

International Conference for

Technical requirements

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