Zobrazeno 1 - 10
of 17
pro vyhledávání: '"Lesley Reeve"'
Autor:
Brian M. Keyser, Robert Leverette, Michael Hollings, Adam Seymour, Lesley Reeve, Wanda Fields
Publikováno v:
Toxicology Reports, Vol 6, Iss , Pp 1281-1288 (2019)
The Vitrocell® VC10® smoke exposure system offers multiple platforms for air liquid interface (ALI) and air agar interface (AAI) exposure that mimic in vivo conditions for assessing toxicological impact of whole smoke using in vitro assays. The aim
Externí odkaz:
https://doaj.org/article/1075d2bdef5f4a809d70929aae8cc66c
Publikováno v:
Toxicology Reports, Vol 5, Iss , Pp 542-551 (2018)
The Ames test has established use in the assessment of potential mutagenicity of tobacco products but has generally been performed using partitioned exposures (e.g. total particulate matter [TPM], gas vapor phase [GVP]) rather than whole smoke (WS).
Externí odkaz:
https://doaj.org/article/e0870b7eb53c40459ac01190980144c2
Autor:
Neeltje Steeghs, Laura Vidal, Dalila Bouyoucef-Cherchalli, Lesley Reeve, Debra Mandarino, Emilie M.J. van Brummelen, Begoña Heras, Andreas Reichl, Stephen Flach
Publikováno v:
British journal of clinical pharmacologyREFERENCES. 88(4)
This review provides tools to consider the inclusion of healthy volunteers (HVs) in first-in-human (FIH) oncology clinical trials with small molecules, including targeted and immunomodulatory agents, a strategy that was not envisioned with classic ch
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c807ce37c4f79273d30145f9ffbd660
https://pubmed.ncbi.nlm.nih.gov/34558113
https://pubmed.ncbi.nlm.nih.gov/34558113
Publikováno v:
Therapeutic Innovation & Regulatory Science. 54:764-769
In 2006, a concept paper (ICH S2(R1)) describing the need for revision of the ICH guidelines on genotoxicity testing for new “small molecule” pharmaceuticals (then ICH S2A and ICH S2B) was finalised. As a result, testing strategy has changed, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e973bf36a88af0ace069e437766454d3
https://doi.org/10.1007/s43441-019-00011-7
https://doi.org/10.1007/s43441-019-00011-7
Publikováno v:
Toxicology Reports, Vol 6, Iss, Pp 1281-1288 (2019)
Toxicology Reports
Toxicology Reports
Graphical abstract
Highlights • Investigation of dose-determining methods using the Vitrocell® VC10® system. • Dose assessment using Quartz Crystal Microbalances (QCM) and aerosol photometers. • Dose assessment using fluorescence of DMSO
Highlights • Investigation of dose-determining methods using the Vitrocell® VC10® system. • Dose assessment using Quartz Crystal Microbalances (QCM) and aerosol photometers. • Dose assessment using fluorescence of DMSO
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eb13929d982956404d4765f420b37b8b
http://www.sciencedirect.com/science/article/pii/S2214750019303890
http://www.sciencedirect.com/science/article/pii/S2214750019303890
Publikováno v:
Toxicology in Vitro. 40:144-152
Cytotoxicity assessment of combustible tobacco products by neutral red uptake (NRU) has historically used total particulate matter (TPM) or solvent captured gas vapor phase (GVP), rather than fresh whole smoke. Here, the development, validation and a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cacaf8ba36fd1491cb431854295dfbd3
https://doi.org/10.1016/j.tiv.2017.01.001
https://doi.org/10.1016/j.tiv.2017.01.001
Autor:
Lesley Reeve, Paul Baldrick
Publikováno v:
Expert Review of Medical Devices. 14:161-167
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::36b8e553f6bae1bed5d53d2ed53f4c7b
https://doi.org/10.1080/17434440.2017.1280392
https://doi.org/10.1080/17434440.2017.1280392
Autor:
Lesley Reeve, Paul Baldrick
Publikováno v:
Therapeutic Innovation & Regulatory Science. 50:101-105
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 Authorisation Application (MAA). An RMP may also be needed for existing products when ther
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::60c8bf3429c45e5bf07e3dc4fb80cbc1
https://doi.org/10.1177/2168479015608414
https://doi.org/10.1177/2168479015608414
Autor:
Brian M. Keyser, Wanda R. Fields, Victoria Hargreaves, Betsy Bombick, Robert Leverette, Kathy Fowler, Lesley Reeve
Publikováno v:
Toxicology in vitro : an international journal published in association with BIBRA. 56
The assessment of potential cytotoxicity or genotoxicity of combustible tobacco products has historically been performed using partitioned exposures (i.e. total particulate matter [TPM], gas vapor phase [GVP]) rather than whole smoke. The VITROCELL®
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2766effe7c2cc8e158a7e14ea3480df7
https://pubmed.ncbi.nlm.nih.gov/30576853
https://pubmed.ncbi.nlm.nih.gov/30576853
Publikováno v:
Journal of Applied Toxicology. 32:608-616
The allergy vaccine Pollinex® Quattro Grass, developed for the prevention/relief of allergic symptoms caused by grass pollen in adults and children, contains extracts of 12 grass pollens and rye cereal (all chemically modified by glutaraldehyde), ad
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::512b047e482e5054c4c9598848eba205
https://doi.org/10.1002/jat.1726
https://doi.org/10.1002/jat.1726