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Review of the Technical, Toxicological, and PKPD Considerations for Conducting Inhalation Toxicity Studies on Biologic Pharmaceuticals-The Outcome of a Cross-Industry Working Group Survey.
Wolfreys A, Kilgour J, Allen AD, Dudal S, Freke M, Jones D, Karantabias G, Krantz C, Moore S, Mukaratirwa S, Price M, Tepper J, Cauvin A, Manetz S, Robinson I. Wolfreys A, et al. Among authors: jones d. Toxicol Pathol. 2021 Feb;49(2):261-285. doi: 10.1177/0192623321988841. Epub 2021 Feb 3. Toxicol Pathol. 2021. PMID: 33535023 Review.
BSTP Review of 12 Case Studies Discussing the Challenges, Pathology, Immunogenicity, and Mechanisms of Inhaled Biologics.
Hall AP, Tepper JS, Boyle MH, Cary MG, Flandre TG, Piaia A, Tarnow I, Macri NP, Freke MC, Nikula KJ, Paul GR, Cauvin A, Gregori M, Haworth R, Naylor S, Price M, Robinson IN, Allen A, Gelzleichter T, Hohlbaum AM, Manetz S, Wolfreys A, Colman K, Fleurance R, Jones D, Mukaratirwa S. Hall AP, et al. Among authors: jones d. Toxicol Pathol. 2021 Feb;49(2):235-260. doi: 10.1177/0192623320976094. Epub 2021 Jan 18. Toxicol Pathol. 2021. PMID: 33455525 Review.
Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.
Prior H, Baldrick P, Beken S, Booler H, Bower N, Brooker P, Brown P, Burlinson B, Burns-Naas LA, Casey W, Chapman M, Clarke D, de Haan L, Doehr O, Downes N, Flaherty M, Gellatly N, Moesgaard SG, Harris J, Holbrook M, Hui J, Jones D, Jones K, Kedar H, Mahl A, Manninen A, McGuire A, Mortimer-Cassen E, Peraza M, Pugsley MK, Richard J, Roberts R, Roosen W, Rothfuss A, Schoenmakers A, Sewell F, Weaver R, Weir L, Wolfreys A, Kimber I. Prior H, et al. Among authors: jones d, jones k. Regul Toxicol Pharmacol. 2020 Jun;113:104624. doi: 10.1016/j.yrtph.2020.104624. Epub 2020 Feb 29. Regul Toxicol Pharmacol. 2020. PMID: 32126256 Free article.
In silico toxicology protocols.
Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Burden N, Cammerer Z, Cronin MTD, Cross KP, Custer L, Dettwiler M, Dobo K, Ford KA, Fortin MC, Gad-McDonald SE, Gellatly N, Gervais V, Glover KP, Glowienke S, Van Gompel J, Gutsell S, Hardy B, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Hughes K, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kim MT, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Majer B, Masten S, Miller S, Moser J, Mumtaz M, Muster W, Neilson L, Oprea TI, Patlewicz G, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Ruiz P, Schilter B, Serafimova R, Simpson W, Stavitskaya L, Stidl R, Suarez-Rodriguez D, Szabo DT, Teasdale A, Trejo-Martin A, Valentin JP, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Hasselgren C. Myatt GJ, et al. Among authors: jones d. Regul Toxicol Pharmacol. 2018 Jul;96:1-17. doi: 10.1016/j.yrtph.2018.04.014. Epub 2018 Apr 17. Regul Toxicol Pharmacol. 2018. PMID: 29678766 Free PMC article.
Is there a role for the no observed adverse effect level in safety pharmacology?
Mow T, Andersen NK, Dragsted N, Lassen AB, Laursen M, Bass AS, Valentin JP, Markgraf C, Authier S, Baird TJ, Bhatt S, Traebert M, Leishman DJ, Jones D, Curtis MJ. Mow T, et al. Among authors: jones d. J Pharmacol Toxicol Methods. 2020 Sep;105:106917. doi: 10.1016/j.vascn.2020.106917. Epub 2020 Aug 29. J Pharmacol Toxicol Methods. 2020. PMID: 32866658
Genetic toxicology in silico protocol.
Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger LT, Atienzar F, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Cammerer Z, Cronin MTD, Crooks I, Cross KP, Custer L, Dobo K, Doktorova T, Faulkner D, Ford KA, Fortin MC, Frericks M, Gad-McDonald SE, Gellatly N, Gerets H, Gervais V, Glowienke S, Van Gompel J, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Barton-Maclaren TS, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Masten S, Miller S, Moudgal C, Muster W, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Schilter B, Snyder RD, Stavitskaya L, Stidl R, Szabo DT, Teasdale A, Tice RR, Trejo-Martin A, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Myatt GJ. Hasselgren C, et al. Among authors: jones d. Regul Toxicol Pharmacol. 2019 Oct;107:104403. doi: 10.1016/j.yrtph.2019.104403. Epub 2019 Jun 11. Regul Toxicol Pharmacol. 2019. PMID: 31195068 Free PMC article.
Predicting the safety of medicines in pregnancy: A workshop report.
Clements JM, Hawkes RG, Jones D, Adjei A, Chambers T, Simon L, Stemplewski H, Berry N, Price S, Pirmohamed M, Piersma AH, Waxenecker G, Barrow P, Beekhuijzen MEW, Fowkes A, Prior H, Sewell F. Clements JM, et al. Among authors: jones d. Reprod Toxicol. 2020 Apr;93:199-210. doi: 10.1016/j.reprotox.2020.02.011. Epub 2020 Feb 29. Reprod Toxicol. 2020. PMID: 32126282 Free article.
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