Literature DB >> 28797172

A decade of drug metabolite safety testing: industry and regulatory shared learning.

Debra Luffer-Atlas1, Aisar Atrakchi2.   

Abstract

Keywords:  Disproportionate human metabolites; FDA guidance; metabolite safety testing; safety coverage

Mesh：

Substances：

Year:  2017        PMID： 28797172     DOI： 10.1080/17425255.2017.1364362

Source DB:  PubMed          Journal:  Expert Opin Drug Metab Toxicol        ISSN： 1742-5255            Impact factor:   4.481


× No keyword cloud information.
  2 in total

Review 1.  Comprehensive Evaluation of Organotypic and Microphysiological Liver Models for Prediction of Drug-Induced Liver Injury.

Authors:  Yitian Zhou; Joanne X Shen; Volker M Lauschke
Journal:  Front Pharmacol       Date:  2019-09-24       Impact factor: 5.810

Review 2.  The Importance of the Human Mass Balance Study in Regulatory Submissions.

Authors:  Paola Coppola; Anita Andersson; Susan Cole
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2019-10-25
  2 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.