Author:
Scott Brandon S.,Zhang Kelly,Yehl Peter M.,Yang Samuel H.
Subject
Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry
Reference21 articles.
1. Guidance for Industry Q3B(R2) Impurities in New Drug Products, International Consortium of Harmonisation (ICH) ICH Q3B(R2) Impurities in New Drug Products, (2006),
2. Preclinical in vivo ADME studies in drug development: a critical review;Pellegatti;Expert Opin. Drug Metab. Toxicol.,2012
3. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, International Consortium of Harmonisation (ICH) ICH M3(R2) (2010),
4. Mass balance, metabolic disposition, and pharmacokinetics of [14C]ensartinib, a novel potent anaplastic lymphoma kinase (ALK) inhibitor, in healthy subjects following oral administration;Zhou;Cancer Chemother. Pharmacol.,2020
5. Mass balance and metabolite profiling of 14C-guadecitabine in patients with advanced cancer;Roosendaal;Investig. N. Drugs,2020