In Vitro Analysis of N-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions-Reference-Cited by-同舟云学术

In Vitro Analysis of N-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions

Published:2021-06-28 Issue:6 Volume:4 Page:e2118253
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Gao Zongming¹,Karfunkle Michael¹,Ye Wei¹,Marzan Tim Andres¹,Yang Jingyue¹,Lex Timothy¹,Sommers Cynthia¹,Rodriguez Jason D.¹,Han Xiaomei²,Florian Jeffry²,Strauss David G.²,Keire David A.¹

Affiliation:

1. Division of Complex Drug Analysis and Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, St Louis, Missouri

2. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration. Silver Spring, Maryland

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2781455/gao_2021_oi_210538_1626277654.40376.pdf

Reference38 articles.

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2. Ranitidine–investigations into the root cause for the presence of N-nitroso-N, N-dimethylamine in ranitidine hydrochloride drug substances and associated drug products.;King;Organic Process Res Dev,2020

3. Analysis of ranitidine-associated N-nitrosodimethylamine production under simulated physiologic conditions.;Braunstein;JAMA Netw Open,2021

4. Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine.;Zeng;Carcinogenesis,2016

5. Formation of N-nitroso compounds: chemistry, kinetics, and in vivo occurrence.;Mirvish;Toxicol Appl Pharmacol,1975

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