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Expert review of medical devices, 02/2017, Volume 14, Issue 2, p. 161
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available,... 
Materials Testing - methods | Prosthesis Implantation | Equipment and Supplies - adverse effects | Humans | Medical Device Legislation
Journal Article
Proceedings of the National Academy of Sciences of the United States of America, ISSN 0027-8424, 10/2013, Volume 110, Issue 40, pp. 16265 - 16270
Journal Article
Toxicology Reports, ISSN 2214-7500, 01/2018, Volume 5, pp. 542 - 551
The Ames test has established use in the assessment of potential mutagenicity of tobacco products but has generally been performed using partitioned exposures... 
Ames test | Whole smoke | Tobacco heating product | Eclipse | 3R4F | Mutagenicity | Smoke exposure system
Journal Article
Toxicology Reports, ISSN 2214-7500, 2019, Volume 6, pp. 1281 - 1288
[Display omitted] •Investigation of dose-determining methods using the Vitrocell® VC10® system.•Dose assessment using Quartz Crystal Microbalances (QCM) and... 
Smoke exposure system | Dosimetry | Whole smoke | Aerosol | Photometers
Journal Article
Therapeutic Innovation & Regulatory Science, ISSN 2168-4790, 1/2016, Volume 50, Issue 1, pp. 101 - 105
Within the European Union (EU) there is a requirement to submit a risk management plan (RMP) for a proposed new drug at the time of submission of the Marketing... 
RMP | potential risk | risk management plan | safety specification | risk-benefit | identified risk | MEDICAL INFORMATICS | PHARMACOLOGY & PHARMACY | Studies | Breastfeeding & lactation | Authorship | Risk management | Marketing
Journal Article
by Easton, Douglas F and Pooley, Karen A and Dunning, Alison M and Pharoah, Paul D. P and Thompson, Deborah and Ballinger, Dennis G and Struewing, Jeffery P and Morrison, Jonathan and Field, Helen and Luben, Robert and Wareham, Nicholas and Ahmed, Shahana and Healey, Catherine S and Bowman, Richard and Meyer, Kerstin B and Haiman, Christopher A and Kolonel, Laurence K and Henderson, Brian E and Le Marchand, Loic and Brennan, Paul and Sangrajrang, Suleeporn and Gaborieau, Valerie and Odefrey, Fabrice and Shen, Chen-Yang and Wu, Pei-Ei and Wang, Hui-Chun and Eccles, Diana and Evans, D. Gareth and Peto, Julian and Fletcher, Olivia and Johnson, Nichola and Seal, Sheila and Stratton, Michael R and Rahman, Nazneen and Chenevix-Trench, Georgia and Bojesen, Stig E and Nordestgaard, Børge G and Axelsson, Christen K and Garcia-Closas, Montserrat and Brinton, Louise and Chanock, Stephen and Lissowska, Jolanta and Peplonska, Beata and Nevanlinna, Heli and Fagerholm, Rainer and Eerola, Hannaleena and Kang, Daehee and Yoo, Keun-Young and Noh, Dong-Young and Ahn, Sei-Hyun and Hunter, David J and Hankinson, Susan E and Cox, David G and Hall, Per and Ween, Sara and Liu, Jianjun and Low, Yen-Ling and Bogdanova, Natalia and Schürmann, Peter and Dörk, Thilo and Tollenaar, Rob A. E. M and Jacobi, Catharina E and Devilee, Peter and Klijn, Jan G. M and Sigurdson, Alice J and Doody, Michele M and Alexander, Bruce H and Zhang, Jinghui and Cox, Angela and Brock, Ian W and MacPherson, Gordon and Reed, Malcolm W. R and Couch, Fergus J and Goode, Ellen L and Olson, Janet E and Meijers-Heijboer, Hanne and van den Ouweland, Ans and Uitterlinden, Ané and Rivadeneira, Fernando and Milne, Roger L and Ribas, Gloria and Gonzalez-Neira, Anna and Benitez, Javier and Hopper, John L and McCredie, Margaret and Southey, Melissa and Giles, Graham G and Schroen, Chris and Justenhoven, Christina and Brauch, Hiltrud and Hamann, Ute and Ko, Yon-Dschun and Spurdle, Amanda B and Beesley, Jonathan and Chen, Xiaoqing and Mannermaa, Arto and Kosma, Veli-Matti and Kataja, Vesa and Hartikainen, Jaana and Day, Nicholas E and ... and kConFab and AOCS Management Grp and SEARCH Collaborators and AOCS Management Group and SEARCH collaborators and The SEARCH collaborators
Nature, ISSN 0028-0836, 2007, Volume 447, Issue 7148, pp. 1087 - 1093
Journal Article
Toxicology in vitro : an international journal published in association with BIBRA, 12/2018, Volume 56, p. 19
The assessment of potential cytotoxicity or genotoxicity of combustible tobacco products has historically been performed using partitioned exposures (i.e.... 
Journal Article
Mut.Res.-Genetic Toxicology and Environmental Mutagenesis, ISSN 1383-5718, 2011, Volume 721, Issue 1, pp. 27 - 73
Journal Article