Detalhe da pesquisa
1.
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs).
Regul Toxicol Pharmacol
; 142: 105415, 2023 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-37257751
2.
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines.
Regul Toxicol Pharmacol
; 135: 105247, 2022 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-35998738
3.
Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey.
Regul Toxicol Pharmacol
; 122: 104895, 2021 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-33610610
4.
Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA).
Regul Toxicol Pharmacol
; 123: 104926, 2021 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-33862169
5.
Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop.
Int J Toxicol
; 40(3): 285-298, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-33525949
6.
Qualification of impurities based on metabolite data.
Regul Toxicol Pharmacol
; 110: 104524, 2020 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-31734179
7.
Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs).
Regul Toxicol Pharmacol
; 79 Suppl 1: S48-56, 2016 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-27233925
8.
Using default methodologies to derive an acceptable daily exposure (ADE).
Regul Toxicol Pharmacol
; 79 Suppl 1: S28-38, 2016 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-27233926
9.
A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.
Regul Toxicol Pharmacol
; 79 Suppl 1: S39-47, 2016 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-27267172
10.
Threshold of toxicological concern (TTC) for developmental and reproductive toxicity of anticancer compounds.
Regul Toxicol Pharmacol
; 72(3): 602-9, 2015 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-26025210
11.
Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials.
Regul Toxicol Pharmacol
; 65(1): 162-7, 2013 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-22732128
12.
Advancing toxicology in RiskMAPP: setting ADEs based on the subsequent drug substance.
Regul Toxicol Pharmacol
; 65(1): 157-61, 2013 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-22921793
13.
Comparison of the transgenic rodent mutation assay, error corrected next generation duplex sequencing, and the alkaline comet assay to detect dose-related mutations following exposure to N-nitrosodiethylamine.
Mutat Res Genet Toxicol Environ Mutagen
; 891: 503685, 2023 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-37770142
14.
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls).
PDA J Pharm Sci Technol
; 76(5): 369-383, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-35031541
15.
A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens.
Crit Rev Toxicol
; 41(6): 507-44, 2011 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-21591905
16.
In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances.
Regul Toxicol Pharmacol
; 57(2-3): 300-6, 2010.
Artigo
em Inglês
| MEDLINE | ID: mdl-20363275
17.
Toxicogenomics and cancer risk assessment: a framework for key event analysis and dose-response assessment for nongenotoxic carcinogens.
Regul Toxicol Pharmacol
; 58(3): 369-81, 2010 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-20801182
18.
A strategy for the risk assessment of human genotoxic metabolites.
Chem Res Toxicol
; 22(2): 348-56, 2009 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-19170655
19.
Overview of genotoxic impurities in pharmaceutical development.
Int J Toxicol
; 28(6): 468-78, 2009.
Artigo
em Inglês
| MEDLINE | ID: mdl-19966139
20.
A Case to Support the Continued Use of Rifampin in Clinical Drug-Drug Interaction Studies.
Clin Pharmacol Ther
; 2024 Mar 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-38494918