自引率: 16.5%
被引量: 6858
通过率: 暂无数据
审稿周期: 1.67
版面费用: 暂无数据
国人发稿量: 57
投稿须知/期刊简介:
Regulatory Toxicology and Pharmacology, Official Journal of the International Society for Regulatory Toxicology and Pharmacology, reports the concepts and problems involved with the generation, evaluation, and interpretation of experimental animal and human data in the larger perspective of the societal considerations of protecting human health and the environment. The journal is devoted to reports of significant developments, public opinion, scientific data, and ideas that bridge the gap between scientific information and the legal aspects of toxicological and pharmacological regulations.
期刊描述简介:
Regulatory Toxicology and Pharmacology, Official Journal of the International Society for Regulatory Toxicology and Pharmacology, reports the concepts and problems involved with the generation, evaluation, and interpretation of experimental animal and human data in the larger perspective of the societal considerations of protecting human health and the environment. The journal is devoted to reports of significant developments, public opinion, scientific data, and ideas that bridge the gap between scientific information and the legal aspects of toxicological and pharmacological regulations.
-
Residue depletion profiles and withdrawal intervals of florfenicol and its metabolite florfenicol amine in plasma and milk of lactating goats after repeated subcutaneous administrations.
被引量：- 发表：1970
-
Botanical-induced toxicity: Liver injury and botanical-drug interactions. A report on a society of Toxicology Annual Meeting symposium.
被引量：- 发表：1970
-
Reevaluating safety pharmacology respiratory studies within the ICH S7A core battery: A multi-company evaluation of preclinical utility and clinical translation.
被引量：- 发表：1970
-
Building knowledge of NAMs through risk science.
被引量：- 发表：1970
-
Safety assessment of protein A and derivation of a parenteral health-based exposure limit.
Protein A (PA) is a bacterial cell wall component of Staphylococcus aureus whose function is to bind to Immunoglobulin G (IgG). Given its ability to bind IgG as well as its stability and resistance to harsh acidic and basic cleaning conditions, it is commonly used in the affinity chromotography purification of biotherapeutics. This use can result in levels of PA being present in a drug product and subsequent patient exposure. Interestingly, PA was previously evaluated in clinical trials as well as supporting nonclinical studies, resulting in a database that enables the derivation of a health-based exposure limit (HBEL). Given the widespread use of PA in the pharmaceutical industry, the IQ DruSafe Impurities Safety Working Group (WG) evaluated the available information with the purpose of establishing a harmonized parenteral HBEL for PA. Based on this thorough, collaborative evaluation of nonclinical and clinical data available for PA, a parenteral HBEL of 1.2 μg/kg/dose (60 μg/dose for a 50 kg individual) is expected to be health protective for patients when it is present as an impurity in a biotherapeutic.
被引量：- 发表：1970
