350 related articles for article (PubMed ID: 19607870)
1. A perspective on testing of existing pharmaceutical excipients for genotoxic impurities.
Brusick DJ
Regul Toxicol Pharmacol; 2009 Nov; 55(2):200-4. PubMed ID: 19607870
[TBL] [Abstract][Full Text] [Related]
2. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.
Dobo KL; Greene N; Cyr MO; Caron S; Ku WW
Regul Toxicol Pharmacol; 2006 Apr; 44(3):282-93. PubMed ID: 16464524
[TBL] [Abstract][Full Text] [Related]
3. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity.
Müller L; Mauthe RJ; Riley CM; Andino MM; Antonis DD; Beels C; DeGeorge J; De Knaep AG; Ellison D; Fagerland JA; Frank R; Fritschel B; Galloway S; Harpur E; Humfrey CD; Jacks AS; Jagota N; Mackinnon J; Mohan G; Ness DK; O'Donovan MR; Smith MD; Vudathala G; Yotti L
Regul Toxicol Pharmacol; 2006 Apr; 44(3):198-211. PubMed ID: 16412543
[TBL] [Abstract][Full Text] [Related]
4. Recent developments in the risk assessment of potentially genotoxic impurities in pharmaceutical drug substances.
Humfrey CD
Toxicol Sci; 2007 Nov; 100(1):24-8. PubMed ID: 17656486
[TBL] [Abstract][Full Text] [Related]
5. Characterization and validation of an in silico toxicology model to predict the mutagenic potential of drug impurities.
Valerio LG; Cross KP
Toxicol Appl Pharmacol; 2012 May; 260(3):209-21. PubMed ID: 22426359
[TBL] [Abstract][Full Text] [Related]
6. Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance.
Bercu JP; Hoffman WP; Lee C; Ness DK
Regul Toxicol Pharmacol; 2008 Aug; 51(3):270-7. PubMed ID: 18550240
[TBL] [Abstract][Full Text] [Related]
7. Overview of genotoxic impurities in pharmaceutical development.
Bercu JP; Dobo KL; Gocke E; McGovern TJ
Int J Toxicol; 2009; 28(6):468-78. PubMed ID: 19966139
[TBL] [Abstract][Full Text] [Related]
8. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
Giordani A; Kobel W; Gally HU
Eur J Pharm Sci; 2011 May; 43(1-2):1-15. PubMed ID: 21420491
[TBL] [Abstract][Full Text] [Related]
9. Improved in silico prediction of carcinogenic potency (TD50) and the risk specific dose (RSD) adjusted Threshold of Toxicological Concern (TTC) for genotoxic chemicals and pharmaceutical impurities.
Contrera JF
Regul Toxicol Pharmacol; 2011 Feb; 59(1):133-41. PubMed ID: 20933038
[TBL] [Abstract][Full Text] [Related]
10. [Selected bacterial tests used for detection of genotoxic properties of chemical compounds].
Jenek J
Rocz Panstw Zakl Hig; 1988; 39(6):475-84. PubMed ID: 3075814
[No Abstract] [Full Text] [Related]
11. An evaluation of the sensitivity of the Ames assay to discern low-level mutagenic impurities.
Kenyon MO; Cheung JR; Dobo KL; Ku WW
Regul Toxicol Pharmacol; 2007 Jun; 48(1):75-86. PubMed ID: 17379368
[TBL] [Abstract][Full Text] [Related]
12. Chemical reagents as potential impurities of pharmaceutical products: investigations on their genotoxic activity.
Friscia O; Pulci R; Fassio F; Comelli R
J Environ Pathol Toxicol Oncol; 1994; 13(2):89-110. PubMed ID: 7884648
[TBL] [Abstract][Full Text] [Related]
13. Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs).
Elder DP; Lipczynski AM; Teasdale A
J Pharm Biomed Anal; 2008 Nov; 48(3):497-507. PubMed ID: 18657926
[TBL] [Abstract][Full Text] [Related]
14. Toxicological overview of impurities in pharmaceutical products.
Jacobson-Kram D; McGovern T
Adv Drug Deliv Rev; 2007 Jan; 59(1):38-42. PubMed ID: 17188779
[TBL] [Abstract][Full Text] [Related]
15. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process.
Liu DQ; Chen TK; McGuire MA; Kord AS
J Pharm Biomed Anal; 2009 Sep; 50(2):144-50. PubMed ID: 19427156
[TBL] [Abstract][Full Text] [Related]
16. Role of in silico genotoxicity tools in the regulatory assessment of pharmaceutical impurities.
Fioravanzo E; Bassan A; Pavan M; Mostrag-Szlichtyng A; Worth AP
SAR QSAR Environ Res; 2012; 23(3-4):257-77. PubMed ID: 22369620
[TBL] [Abstract][Full Text] [Related]
17. Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product.
Eichenbaum G; Johnson M; Kirkland D; O'Neill P; Stellar S; Bielawne J; DeWire R; Areia D; Bryant S; Weiner S; Desai-Krieger D; Guzzie-Peck P; Evans DC; Tonelli A
Regul Toxicol Pharmacol; 2009 Oct; 55(1):33-42. PubMed ID: 19500632
[TBL] [Abstract][Full Text] [Related]
18. Control and analysis of hydrazine, hydrazides and hydrazones--genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products.
Elder DP; Snodin D; Teasdale A
J Pharm Biomed Anal; 2011 Apr; 54(5):900-10. PubMed ID: 21145684
[TBL] [Abstract][Full Text] [Related]
19. Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities.
Gunther WC; Kenyon MO; Cheung JR; Dugger RW; Dobo KL
Regul Toxicol Pharmacol; 2017 Dec; 91():68-76. PubMed ID: 29061373
[TBL] [Abstract][Full Text] [Related]
20. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective.
Raman NV; Prasad AV; Ratnakar Reddy K
J Pharm Biomed Anal; 2011 Jun; 55(4):662-7. PubMed ID: 21193280
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
