Matches in SemOpenAlex for { <https://semopenalex.org/work/W4313442487> ?p ?o ?g. }
- W4313442487 endingPage "1182" @default.
- W4313442487 startingPage "1166" @default.
- W4313442487 abstract "N-Nitrosamines (also referred to as nitrosamines) are a class of substances, many of which are highly potent mutagenic agents which have been classified as probable human carcinogens. Nitrosamine impurities have been a concern within the pharmaceutical industry and by regulatory authorities worldwide since June 2018, when regulators were informed of the presence of N-nitrosodimethylamine (NDMA) in the angiotensin-II receptor blocker (ARB) medicine, valsartan. Since that time, regulatory authorities have collaborated to share information and knowledge on issues related to nitrosamines with a goal of promoting convergence on technical issues and reducing and mitigating patient exposure to harmful nitrosamine impurities in human drug products. This paper shares current scientific information from a quality perspective on risk factors and potential root causes for nitrosamine impurities, as well as recommendations for risk mitigation and control strategies." @default.
- W4313442487 created "2023-01-06" @default.
- W4313442487 creator A5007676002 @default.
- W4313442487 creator A5009144198 @default.
- W4313442487 creator A5009773568 @default.
- W4313442487 creator A5019834230 @default.
- W4313442487 creator A5021374420 @default.
- W4313442487 creator A5026519868 @default.
- W4313442487 creator A5036616797 @default.
- W4313442487 creator A5050524152 @default.
- W4313442487 creator A5065582730 @default.
- W4313442487 creator A5065968104 @default.
- W4313442487 creator A5067955332 @default.
- W4313442487 creator A5073599716 @default.
- W4313442487 creator A5078220645 @default.
- W4313442487 creator A5079418503 @default.
- W4313442487 creator A5085828126 @default.
- W4313442487 date "2023-05-01" @default.
- W4313442487 modified "2023-10-11" @default.
- W4313442487 title "Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals" @default.
- W4313442487 cites W1965555285 @default.
- W4313442487 cites W1971513988 @default.
- W4313442487 cites W1977570715 @default.
- W4313442487 cites W1981268467 @default.
- W4313442487 cites W1985988549 @default.
- W4313442487 cites W1990941130 @default.
- W4313442487 cites W1997545072 @default.
- W4313442487 cites W1998658518 @default.
- W4313442487 cites W2001810004 @default.
- W4313442487 cites W2002331381 @default.
- W4313442487 cites W2002660875 @default.
- W4313442487 cites W2003357716 @default.
- W4313442487 cites W2003666522 @default.
- W4313442487 cites W2004186896 @default.
- W4313442487 cites W2008994497 @default.
- W4313442487 cites W2010906980 @default.
- W4313442487 cites W2015329832 @default.
- W4313442487 cites W2015492568 @default.
- W4313442487 cites W2015728684 @default.
- W4313442487 cites W2015889277 @default.
- W4313442487 cites W2019512261 @default.
- W4313442487 cites W2020888078 @default.
- W4313442487 cites W2021140447 @default.
- W4313442487 cites W2025592056 @default.
- W4313442487 cites W2027042950 @default.
- W4313442487 cites W2027601066 @default.
- W4313442487 cites W2030197801 @default.
- W4313442487 cites W2031558866 @default.
- W4313442487 cites W2032864127 @default.
- W4313442487 cites W2033626139 @default.
- W4313442487 cites W2035485941 @default.
- W4313442487 cites W2038676839 @default.
- W4313442487 cites W2038900966 @default.
- W4313442487 cites W2041007507 @default.
- W4313442487 cites W2042928907 @default.
- W4313442487 cites W2043804740 @default.
- W4313442487 cites W2058957264 @default.
- W4313442487 cites W2059195826 @default.
- W4313442487 cites W2059582361 @default.
- W4313442487 cites W2072103657 @default.
- W4313442487 cites W2081072306 @default.
- W4313442487 cites W2082350191 @default.
- W4313442487 cites W2082888074 @default.
- W4313442487 cites W2131978530 @default.
- W4313442487 cites W230047732 @default.
- W4313442487 cites W2616925291 @default.
- W4313442487 cites W2766629815 @default.
- W4313442487 cites W2770930683 @default.
- W4313442487 cites W2792067343 @default.
- W4313442487 cites W2884273662 @default.
- W4313442487 cites W2901115243 @default.
- W4313442487 cites W2939430638 @default.
- W4313442487 cites W3038592381 @default.
- W4313442487 cites W3045569055 @default.
- W4313442487 cites W3047059194 @default.
- W4313442487 cites W3048153031 @default.
- W4313442487 cites W3048354044 @default.
- W4313442487 cites W3080404118 @default.
- W4313442487 cites W3081204427 @default.
- W4313442487 cites W3096588794 @default.
- W4313442487 cites W3098865253 @default.
- W4313442487 cites W3108811720 @default.
- W4313442487 cites W3123877757 @default.
- W4313442487 cites W3163007355 @default.
- W4313442487 cites W3175038316 @default.
- W4313442487 cites W3175970099 @default.
- W4313442487 cites W3184478193 @default.
- W4313442487 cites W3185973187 @default.
- W4313442487 cites W3193949320 @default.
- W4313442487 cites W3197239011 @default.
- W4313442487 cites W3204325913 @default.
- W4313442487 cites W3217764856 @default.
- W4313442487 cites W4210255809 @default.
- W4313442487 cites W4214602843 @default.
- W4313442487 cites W4220757963 @default.
- W4313442487 cites W4223650627 @default.
- W4313442487 cites W4224254287 @default.
- W4313442487 cites W4224260803 @default.