1997
DOI: 10.1080/109158197226955 View full text |Buy / Rent full text
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Abstract: This overview of the Fourth International Conference on Harmonization (ICH 4), held in Brussels, Belgium, 16-18 July 1997, summarizes results and provides information regarding the nonclinical workshop and issued nonclinical testing guidelines [Draft Final (Step 4) Guidelines recommended for adoption to the regulatory bodies of the EU, Japan, and the USA]. ICH 4 completed the initial harmonization targets for the three ICH Regions [European Commission-European Union (EU) and European Federation of Pharmaceutic… Show more

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“…It also ensures that all the information should be integrated in the carcinogenic risk assessment process by improving the understanding of the real cancer risks for patients who receive treatment with pharmaceuticals. [36] The ICH guidelines: A new approach Carcinogenicity studies are generally conducted to identify a tumorigenic potential of a drug in animals and to assess the relevant risk in humans. The guidelines issued by the ICH covers all pharmaceutical agents including biotechnology-derived pharmaceuticals, which need carcinogenic testing before regulatory approval.…”
Section: Assessment Of Human Cancer Risk: Challenges and Regulationsmentioning
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“…It also ensures that all the information should be integrated in the carcinogenic risk assessment process by improving the understanding of the real cancer risks for patients who receive treatment with pharmaceuticals. [36] The ICH guidelines: A new approach Carcinogenicity studies are generally conducted to identify a tumorigenic potential of a drug in animals and to assess the relevant risk in humans. The guidelines issued by the ICH covers all pharmaceutical agents including biotechnology-derived pharmaceuticals, which need carcinogenic testing before regulatory approval.…”
Section: Assessment Of Human Cancer Risk: Challenges and Regulationsmentioning