https://orcid.org/0000-0002-7708-7699
References
- Berman CL, Barros SA, Galloway SM, Kasper P, Oleson FB, Catherine Priestley CC, Sweder KS, Schlosser MJ, Sobol Z. 2016. OSWG recommendations for genotoxicity testing of Novel oligonucleotide-based therapeutics. Nucleic Acid Ther. 26(2):73–85. doi: 10.1089/nat.2015.0534.
- [CHMP]. 2005. CHMP SWP reflection paper on the assessment of the genotoxic potential of antisense oligodeoxynucleotides; [accessed 2023 May 17]. https://www.ema.europa.eu/en/assessment-genotoxic-potential-antisense-oligodeoxynucleotides-scientific-guideline.
- D’Aloisio V, Dognini P, Hutcheon GA, Coxon CR. 2021. PepTherDia: database and structural composition analysis of approved peptide therapeutics and diagnostics. Drug Discov Today. 26(6):1409–1419. doi: 10.1016/j.drudis.2021.02.019.
- [EMA]. 2022. Concept paper on the establishment of a guideline on the development and manufacture of synthetic oligonucleotides; [accessed 2023 May 17]. https://www.ema.europa.eu/en/establishment-guideline-development-manufacture-synthetic-oligonucleotides-scientific-guideline.
- Ewles M, Goodwin L, Schneider A, Rothhammer-Hampl T. 2014. Quantification of oligonucleotides by LC-MS/MS: the challenges of quantifying a phosphorothioate oligonucleotide and multiple metabolites. Bioanalysis. 6(4):447–464. doi: 10.4155/bio.13.319.
- [FDA]. 2021. Guideline on nonclinical testing of individualized antisense oligonucleotide drug products for severely debilitating or life-threatening diseases; [accessed 2023 May 17]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonclinical-testing-individualized-antisense-oligonucleotide-drug-products-severely-debilitating-or.
- Hemsley M, Ewles M, Goodwin L. 2012. Development of a bioanalytical method for quantification of a 15-mer oligonucleotide at sub-ng/ml concentrations using LC-MS/MS. Bioanalysis. 4(12):1457–1469. doi: 10.4155/bio.12.117.
- Hood S, Kenworthy D, Christensen JK. 2022. Meeting report: oligonucleotide ADME Workshop. Xenobiotica. 52(8):957–961. doi: 10.1080/00498254.2022.2115428.
- Humphreys S, Davis JA, Iqbal S, Kamel A, Kulmatycki K, Lao Y, Liu X, Rodgers J, Snoeys J, Vigil A, et al. 2022. Considerations and recommendations for assessment of plasma protein binding and drug-drug interactions for siRNA therapeutics. Nucleic Acids Res. 50(11):6020–6037. doi: 10.1093/nar/gkac456.
- [ICH]. 2009. Guideline on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3(R2); [accessed 2023 May 17]. https://www.ich.org/page/multidisciplinary-guidelines.
- [ICH]. 2011. Guideline on preclinical safety evaluation of biotechnology-derived pharmaceuticals S6(R1); [accessed 2023 May 17]. https://www.ich.org/page/safety-guidelines.
- Jyrkäs J, Tolonen A. 2021. Hepatic in vitro metabolism of peptides; Comparison of human liver S9, hepatocytes and Upcyte hepatocytes with cyclosporine A, leuprorelin, desmopressin and cetrorelix as model compounds. J Pharm Biomed Anal. 196:113921. doi: 10.1016/j.jpba.2021.113921.
- Jyrkäs J, Lassila T, Tolonen A. 2023. Extrahepatic in vitro metabolism of peptides; comparison of human kidney and intestinal S9 fraction, human plasma and proximal tubule cells, using cyclosporine A, leuprorelin, and cetrorelix as model compounds. J Pharm Biomed Anal. 225:115219. doi: 10.1016/j.jpba.2022.115219.
- Säll C, Argikar U, Fonseca K, Hilgendorf C, Lopes F, Riedel J, Schiller H, Sonesson A, Umehara K, Wang K. 2023. Industry perspective on therapeutic peptide drug–drug interaction assessments during drug development: a European Federation of pharmaceutical industries and associations White Paper. Clin Pharmacol Ther. 113(6):1199–1216. doi: 10.1002/cpt.2847.
- Sonesson A, Brady K, Bjørnsdottir I, Christensen JK. 2021a. Meeting report: 1st workshop of the peptide ADME discussion group. Xenobiotica. 51(1):122–125. doi: 10.1080/00498254.2020.1729447.
- Sonesson A, Bjørnsdottir I, Christensen JK. 2021b. Meeting report: 2nd workshop of the Peptide ADME discussion group. Xenobiotica. 51(1):1–4. doi: 10.1080/00498254.2020.1784496.
- Sonesson A, Bjørnsdottir I, Christensen JK. 2021c. Meeting report: 3rd Workshop of the Peptide ADME Discussion Group. Xenobiotica. 51(12):1470–1474. doi: 10.1080/00498254.2021.2020377.