International Conference Harmonisation

Robustness of a method is defined as a measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage [International Conference Harmonisation (ICH) Guideline Q2A (2)]. Intervals for method... [Pg.5]

The use of DOE in the pharmaceutical industry began early. For example, S. M. Free, while head of statistics at Smith Kline French in 1957, wrote an internal statistics booklet with F. A. Oyer (14). It showed how DOE could be used in formulation development and stability studies. Now called matrixing, this approach is now referenced in International Conference Harmonisation (ICH) Guideline Q1 (15). Many articles on DOE have appeared in the pharmaceutical literature during the past 25 years (16-31). Currently, the routine use of DOE is sporadic. The key to its success is an... [Pg.96]

In November 1997, the Department of Health and Human Services along with the International Conference on Harmonisation (ICH) released a draft guidance for the selection of test procedures, which included chiral drugs. For the development of an enantiopure drug substance, acceptable criteria shall include, if possible, an enan-tioselective assay. This assay should be part of the specification for the identification of an enantiopure drug substance and related enantioenriched impurities [16]. [Pg.254]

International Conference on Harmonisation Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice, Fed Regist. Docket No. 97D-0448, 1997. [Pg.282]

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... [Pg.284]

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]

Harmonisation activities are overseen by a steering committee comprising representatives of each of the six parties, together with observers from the WHO, the European Eree Trade Association (EFTA) and Canada. The Committee meet at least twice each year, with the location rotating between the three regions. The committee also organises major international conferences on harmonisation that are held every 2 years. [Pg.37]

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

Medical Dictionary for Regulatory Activities a creation of the International Conference on Harmonisation used to categorize and code diseases, disorders, and adverse events. [Pg.313]

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]

International Conference on Harmonisation Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data Availability, URL http // www.access. [Pg.790]

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]

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]

International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995, Federal Register 61 18198-18202, April 24,1996. [Pg.309]

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