Teasdale A - Search Results

1

Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study.

Teasdale A, Jahn M, Bailey S, Feilden A, Taylor G, Corcoran ML, Malick R, Jenke D, Stults CL, Nagao LM. Teasdale A, et al. AAPS PharmSciTech. 2015 Jun;16(3):664-74. doi: 10.1208/s12249-014-0249-x. Epub 2014 Dec 16. AAPS PharmSciTech. 2015. PMID: 25511807 Free PMC article.

2

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

Broschard TH, Glowienke S, Bruen US, Nagao LM, Teasdale A, Stults CL, Li KL, Iciek LA, Erexson G, Martin EA, Ball DJ. Broschard TH, et al. Among authors: teasdale a. Regul Toxicol Pharmacol. 2016 Nov;81:201-211. doi: 10.1016/j.yrtph.2016.08.011. Epub 2016 Aug 26. Regul Toxicol Pharmacol. 2016. PMID: 27569203 Review.

3

An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.

Boetzel R, Ceszlak A, Day C, Drumm P, Gil Bejar J, Glennon J, Harris L, Heghes CI, Horga R, Jacobs PL, Keurentjes WJTM, King F, Lee CW, Lewen N, Marchant CA, Maris FA, Nye W, Powell S, Rockstroh H, Rutter L, Schweitzer M, Shannon E, Smallshaw L, Teasdale A, Thompson S, Wilkinson D. Boetzel R, et al. Among authors: teasdale a. J Pharm Sci. 2018 Sep;107(9):2335-2340. doi: 10.1016/j.xphs.2018.04.009. Epub 2018 Apr 18. J Pharm Sci. 2018. PMID: 29679706 Free article.

4

A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies.

Barber C, Antonucci V, Baumann JC, Brown R, Covey-Crump E, Elder D, Elliott E, Fennell JW, Gallou F, Ide ND, Jordine G, Kallemeyn JM, Lauwers D, Looker AR, Lovelle LE, McLaughlin M, Molzahn R, Ott M, Schils D, Oestrich RS, Stevenson N, Talavera P, Teasdale A, Urquhart MW, Varie DL, Welch D. Barber C, et al. Among authors: teasdale a. Regul Toxicol Pharmacol. 2017 Nov;90:22-28. doi: 10.1016/j.yrtph.2017.08.008. Epub 2017 Aug 16. Regul Toxicol Pharmacol. 2017. PMID: 28822875

5

Impurities in Oligonucleotide Drug Substances and Drug Products.

Capaldi D, Teasdale A, Henry S, Akhtar N, den Besten C, Gao-Sheridan S, Kretschmer M, Sharpe N, Andrews B, Burm B, Foy J. Capaldi D, et al. Among authors: teasdale a. Nucleic Acid Ther. 2017 Dec;27(6):309-322. doi: 10.1089/nat.2017.0691. Epub 2017 Nov 10. Nucleic Acid Ther. 2017. PMID: 29125795

6

ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database.

Torres S, Boetzel R, Gatimu E, Gomes DZ, King F, Kocks G, Jones R, Day C, Lewen N, Harris L, Teasdale A. Torres S, et al. Among authors: teasdale a. J Pharm Sci. 2022 May;111(5):1421-1428. doi: 10.1016/j.xphs.2021.10.012. Epub 2021 Oct 19. J Pharm Sci. 2022. PMID: 34673095 Free article.

7

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

Popkin ME, Goese M, Wilkinson D, Finnie S, Flanagan T, Campa C, Clinch A, Teasdale A, Lennard A, Cook G, Mohan G, Osborne MD. Popkin ME, et al. Among authors: teasdale a. AAPS J. 2022 Sep 27;24(6):101. doi: 10.1208/s12248-022-00751-9. AAPS J. 2022. PMID: 36168002 Free PMC article. Review.

8

Establishing best practise in the application of expert review of mutagenicity under ICH M7.

Barber C, Amberg A, Custer L, Dobo KL, Glowienke S, Van Gompel J, Gutsell S, Harvey J, Honma M, Kenyon MO, Kruhlak N, Muster W, Stavitskaya L, Teasdale A, Vessey J, Wichard J. Barber C, et al. Among authors: teasdale a. Regul Toxicol Pharmacol. 2015 Oct;73(1):367-77. doi: 10.1016/j.yrtph.2015.07.018. Epub 2015 Aug 4. Regul Toxicol Pharmacol. 2015. PMID: 26248005

9

Management of organic impurities in small molecule medicinal products: Deriving safe limits for use in early development.

Harvey J, Fleetwood A, Ogilvie R, Teasdale A, Wilcox P, Spanhaak S. Harvey J, et al. Among authors: teasdale a. Regul Toxicol Pharmacol. 2017 Mar;84:116-123. doi: 10.1016/j.yrtph.2016.12.011. Epub 2016 Dec 27. Regul Toxicol Pharmacol. 2017. PMID: 28038978 Review.

10

Qualification of impurities based on metabolite data.

Weidolf L, Andersson T, Bercu JP, Brink A, Glowienke S, Harvey J, Hayes MA, Jacques P, Lu C, Manevski N, Muster W, Nudelman R, Ogilvie R, Ottosson J, Teasdale A, Trela B. Weidolf L, et al. Among authors: teasdale a. Regul Toxicol Pharmacol. 2020 Feb;110:104524. doi: 10.1016/j.yrtph.2019.104524. Epub 2019 Nov 14. Regul Toxicol Pharmacol. 2020. PMID: 31734179

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