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Regulatory requirements and ICH guidelines on carcinogenicity testing of pharmaceuticals: A review on current status

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Clinical Guidelines and Recommendations GB Jena, CL Kaul, P Ramarao - Indian journal of pharmacology, 2005 - ijp-online.com

Chapter : Section3
Journal Year : 2005
Cited by : 19.0

» Abstract International regulatory guidelines require that new chemical entities (NCEs) be tested first on animals (preclinical studies) for safety and efficacy before the start of clinical …..... Read More

Keywords : ["regulatory requirement", "ich guideline", "current status", "carcinogenicity testing", "review", "pharmaceutical"]
PubMed Link : https://www.ijp-online.com/article.asp?issn=0253-7613;year=2005;volume=37;issue=4;spage=209;epage=222;aulast=Jena
Google Scholar Link : https://scholar.google.com/scholar?cites=1700181227712209130&as_sdt=805&sciodt=0,3&hl=en&num=20