International Conference on Harmonization ICH of Technical Requirements for

Directive in the EU will be applied more explicitly to pharmaceuticals in order to control discharges to the aquatic environment. The environmental risk assessment of active ingredients is likely to become more sophisticated and uniform among Europe, Japan, and North America. However, a referral to the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use is probably premature in view of the rapid scientific developments in this area. Nevertheless, harmonization by ICH is possible within the next 10 years. 

Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The international standard ISO/ IEC [1] requires validation of nonstandard methods, laboratory designed/devel-oped methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are suitable for their intended use. The Guidance on the Interpretation of the EN 45000 Series of Standards and ISO/IEC Guide 25 includes a chapter on the validation of methods [2] with a list of nine validation parameters. The International Conference on Harmonization (ICH) of Technical Requirements for the... 

Clinical Safety Data Management Definitions and Standards for Expedited Reporting, International Conference on Harmonization [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. http //www.ifpma.org/pdfifpma/ e2a.pdf. 

Unfortunately, national prejudices, politics, and trade policies provide strong barriers to effective harmonization. While international associations such as The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use have made some... 

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... 

There have been various attempts to place the concept of detection limit on a more firm statistical ground. The International Conference on Harmonization (ICH see Chapter 4) of Technical Requirements for Registration of Pharmaceuticals for Human Use has proposed guidelines for analytical method validation (Ref. 18). The ICH Q2B guideline on validation methodology suggests calculation based on the standard deviation, s, of the response and the slope or sensitivity, S, of the calibration curve at levels approaching the limit. For the limit of detection (LOD),... 

International Conference on Harmonization (ICH) A consortium formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacture s Association, the United States Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufactures of America (PhRMA). The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. 

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