A Strategic Approach Towards Mass Balance Investigations in Pharmaceutical Drug Substance Release Testing: A Peculiar Out of Specification Case Study Encountered During API Manufacture

Author:

Scott Brandon,Zhang Kelly,Yehl Peter,Yang Samuel

Publisher

Elsevier BV

Reference21 articles.

1. Preclinical in vivo ADME studies in drug development: A critical review;M Pellegatti;Expert Opinion on Drug Metabolism and Toxicology,2012

2. 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 M3,2010

3. Mass balance, metabolic disposition, and pharmacokinetics of [14C]ensartinib, a novel potent anaplastic lymphoma kinase (ALK) inhibitor, in healthy subjects following oral administration;S Zhou;Cancer Chemotherapy and Pharmacology,2020

4. Mass balance and metabolite profiling of 14Cguadecitabine in patients with advanced cancer;J Roosendaal;Investigational New Drugs,2020

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