Acceptability of Low Levels of Genotoxic Impurities in New Drug Substances

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).

Nigel S. Baber · British Journal of Clinical Pharmacology · 1994 · 767 citations · Full text

Pharmacy, Pharmaceutics, Pharmacology +11

N-nitroso compounds and man

Anthony R. Tricker · European Journal of Cancer Prevention · 1997 · 263 citations

Pharmacy, Toxicology, Analytical Toxicology +6

Cytotoxicity and chromosome aberrations in vitro: Experience in industry and the case for an upper limit on toxicity in the aberration assay

Sheila M. Galloway · Environmental and Molecular Mutagenesis · 2000 · 137 citations

Pharmacy, Toxicology, Mechanisms Of Toxicity +16

Mechanistic Basis for Nonlinearities and Thresholds in Rat Liver Carcinogenesis by the DNA-Reactive Carcinogens 2-Acetylaminofluorene and Diethylnitrosamine

Gary M. Williams, Michael J. Iatropoulos, Alan M. Jeffrey · Toxicologic Pathology · 2000 · 89 citations · Full text

Pharmacy, Oncology, Toxicology +17

Cell Proliferation in the Evaluation of Carcinogenic Risk and the Inadequacies of the Initiation-Promotion Model

Samuel M. Cohen · International Journal of Toxicology · 1998 · 23 citations

Medicine, Cell Biology, Toxicology +16