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Microdosing of a Carbon-14 Labeled Protein in Healthy Volunteers Accurately Predicts Its Pharmacokinetics at Therapeutic Dosages

Publikováno v: Clinical Pharmacology & Therapeutics, 98(2), 196-204. Wiley-Blackwell
Clinical pharmacology and therapeutics, 2, 98, 196-204
Vlaming, M L H, van Duijn, E, Dillingh, M R, Brands, R, Windhorst, A D, Hendrikse, N H, Bosgra, S, Burggraaf, J, Koning, M C, Fidder, A, Mocking, J A J, Sandman, H, de Ligt, R A F, Fabriek, B O, Pasman, W J, Seinen, W, Alves, T, Carrondo, M, Peixoto, C, Peeters, P A M & Vaes, W H J 2015, ' Microdosing of a Carbon-14 Labeled Protein in Healthy Volunteers Accurately Predicts Its Pharmacokinetics at Therapeutic Dosages ', Clinical Pharmacology & Therapeutics, vol. 98, no. 2, pp. 196-204 . https://doi.org/10.1002/cpt.131

Preclinical development of new biological entities (NBEs), such as human protein therapeutics, requires considerable expenditure of time and costs. Poor prediction of pharmacokinetics in humans further reduces net efficiency. In this study, we show f

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Absorption, metabolism and excretion of ¹⁴ C-emvododstat following repeat daily oral dose administration in human volunteers using a combination of microtracer radioactivity and high radioactivity doses .

Autor: Ma J; PTC Therapeutics, United States., Laskin OL; PTC Therapeutics, United States., Roffel AF; ICON plc, Netherlands., Vaes WHJ; Metabolic Health Research, The Netherlands Organization for Applied Scientific Research (TNO), Netherlands., Tang B; PTC Therapeutics, United States., Kolnaar J; ICON plc, Netherlands., O'Keefe K; PTC Therapeutics, United States., Golden L; PTC Therapeutics, United States., Kong R; Clinical Pharmacology & DMPK, PTC Therapeutics, United States rkong@ptcbio.com.

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2023 Oct 18. Date of Electronic Publication: 2023 Oct 18.

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Mass Balance and Absorption, Distribution, Metabolism, and Excretion Properties of Balcinrenone following Oral Administration in Combination with Intravenous Microtracer in Healthy Subjects.

Autor: Lindmark B; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Li XQ; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Bhattacharya C; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Housler G; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Heijer M; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Bragg RA; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Gränfors M; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Pelay-Gimeno M; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Vaes WHJ; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Menakuru S; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Pizzato PE; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Ericsson H; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.)., Johansson S; Drug Metabolism and Pharmacokinetics, Early Research and Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.L., X.-Q.L.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (G.H.); Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden(M.H., H.E., S.J.); Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); Early Product Development and Manufacture, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (M.G.); Quotient Sciences, Nottingham, United Kingdom (S.M.); Early Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.E.P.); and TNO, Leiden, Netherlands (M.P.-G., W.H.J.V.) susanne.a.johansson@astrazeneca.com.

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2023 Aug; Vol. 51 (8), pp. 995-1004. Date of Electronic Publication: 2023 Jul 05.

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Novel Explanted Human Liver Model to Assess Hepatic Extraction, Biliary Excretion and Transporter Function.

Autor: Stevens LJ; Department of Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.; LUMC Transplant Center, Leiden University Medical Center (LUMC), Leiden, The Netherlands.; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., Dubbeld J; Department of Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.; LUMC Transplant Center, Leiden University Medical Center (LUMC), Leiden, The Netherlands., Doppenberg JB; LUMC Transplant Center, Leiden University Medical Center (LUMC), Leiden, The Netherlands., van Hoek B; LUMC Transplant Center, Leiden University Medical Center (LUMC), Leiden, The Netherlands.; Department of Gastroenterology and Hepatology, Leiden University Medical Center (LUMC), Leiden, The Netherlands., Menke AL; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., Donkers JM; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., Alsharaa A; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., de Vries A; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., Vaes WHJ; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., Knibbe CAJ; Division of Systems Biomedicine and Pharmacology, Leiden Academic Center for Drug Research (LACDR), Leiden University, Leiden & Department of Clinical Pharmacy, St. Antonius Hospital Nieuwegein & Utrecht, The Netherlands., van de Steeg E; The Netherlands Organization for Applied Scientific Research (TNO), Leiden, The Netherlands., Alwayn IPJ; Department of Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.; LUMC Transplant Center, Leiden University Medical Center (LUMC), Leiden, The Netherlands.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2023 Jul; Vol. 114 (1), pp. 137-147. Date of Electronic Publication: 2023 May 11.

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Application of Accelerator Mass Spectrometry to Characterize the Mass Balance Recovery and Disposition of AZD4831, a Novel Myeloperoxidase Inhibitor, following Administration of an Oral Radiolabeled Microtracer Dose in Humans.

Autor: Bhattacharya C; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Sandinge AS; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Bragg RA; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Heijer M; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Yan J; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Andersson LC; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Jurva U; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Pelay-Gimeno M; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Vaes WHJ; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., de Ligt RAF; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Gränfors M; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Amilon C; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Lindstedt EL; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Menakuru SR; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Garkaviy P; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Weidolf L; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.)., Gopaul VS; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland (C.B.); DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism (A.-S.S., J.Y., U.J., L.C.A., V.S.G.); Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences (M.H.); and Early Product Development, Pharmaceutical Sciences (M.G.), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Chemical Development, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom (R.A.B.); TNO, Leiden, The Netherlands (M.P.-G., W.H.J.V., R.A.F.d.L.); Quotient Sciences, Nottingham, United Kingdom (S.R.M.); Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (P.G.); and Formerly BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (L.W., C.A., E.-L.L.) sashi.gopaul@astrazeneca.com.

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2023 Apr; Vol. 51 (4), pp. 451-463. Date of Electronic Publication: 2023 Jan 13.

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Assessment of dermal absorption of aluminium from a representative antiperspirant formulation using a ( ²⁶ Al)Al microtracer approach: a follow-up study in humans.

Autor: de Ligt R; TNO, P.O. Box 2215, 2301CE Leiden, The Netherlands., Westerhout J; TNO, P.O. Box 80015, 3508TA Utrecht, The Netherlands., Grossouw D; TNO, P.O. Box 2215, 2301CE Leiden, The Netherlands., Buters TP; Center for Human Drug Research, 2333CL Leiden, The Netherlands., Rissmann R; Center for Human Drug Research, 2333CL Leiden, The Netherlands., Burggraaf J; Center for Human Drug Research, 2333CL Leiden, The Netherlands., Windhorst AD; Department of Radiology and Nuclear Medicine, Free University Medical Center, P.O. Box 7057, 1007MB, Amsterdam, The Netherlands., Tozer S; Procter & Gamble Technical Centres Ltd, Reading RG2 0QE, UK., Pappa G; Beiersdorf AG, Unnastrasse 48, 20245 Hamburg, Germany., Wall B; Colgate Palmolive Company, 909 River Road, Piscataway, NJ 08855, USA., Bury D; L'Oréal Research & Innovation, 9 rue Pierre Dreyfus, 92110 Clichy, France., Mason DR; Safety and Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook MK44 1LQ, UK., Vaes WHJ; TNO, P.O. Box 2215, 2301CE Leiden, The Netherlands.

Publikováno v: Toxicology research [Toxicol Res (Camb)] 2022 May 31; Vol. 11 (3), pp. 511-519. Date of Electronic Publication: 2022 May 31 (Print Publication: 2022).

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Microdosing as a Potential Tool to Enhance Clinical Development of Novel Antibiotics: A Tissue and Plasma PK Feasibility Study with Ciprofloxacin.

Autor: Oesterreicher Z; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.; Internal Medicine 2, Gastroenterology and Hepatology and Rheumatology, University Hospital of St. Pölten, St. Pölten, Austria., Eberl S; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria., Wulkersdorfer B; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria., Matzneller P; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria., Eder C; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria., van Duijn E; TNO, Zeist, The Netherlands., Vaes WHJ; TNO, Zeist, The Netherlands., Reiter B; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria., Stimpfl T; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria., Jäger W; Department of Pharmaceutical Sciences, University of Vienna, Vienna, Austria., Nussbaumer-Proell A; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria., Marhofer D; Department of Anaesthesia, General Intensive Care and Pain Therapy, Medical University of Vienna, Vienna, Austria., Marhofer P; Department of Anaesthesia, General Intensive Care and Pain Therapy, Medical University of Vienna, Vienna, Austria.; Orthopaedic Hospital Speising, Vienna, Austria., Langer O; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria., Zeitlinger M; Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. markus.zeitlinger@meduniwien.ac.at.

Publikováno v: Clinical pharmacokinetics [Clin Pharmacokinet] 2022 May; Vol. 61 (5), pp. 697-707. Date of Electronic Publication: 2022 Jan 07.

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Evaluation of Normothermic Machine Perfusion of Porcine Livers as a Novel Preclinical Model to Predict Biliary Clearance and Transporter-Mediated Drug-Drug Interactions Using Statins.

Autor: Stevens LJ; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.) Lianne.stevens@tno.nl., Zhu AZX; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., Chothe PP; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., Chowdhury SK; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., Donkers JM; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., Vaes WHJ; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., Knibbe CAJ; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., Alwayn IPJ; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.)., van de Steeg E; Department of Surgery, Leiden University Medical Centre (LUMC) Transplant Center, Leiden, The Netherlands (L.J.S., I.P.J.A.); The Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands (L.J.S., J.M.D., W.H.J.V., E.v.d.S.); Quantitative Solutions (A.Z.X.Z.), Department of Drug Metabolism & Pharmacokinetic (P.P.C., S.K.C.), Takeda Pharmaceutical International, Cambridge, Massachusetts; Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research (LACDR), Leiden, The Netherlands (C.A.J.K.); and Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein and Utrecht, The Netherlands (C.A.J.K.) Lianne.stevens@tno.nl.

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2021 Sep; Vol. 49 (9), pp. 780-789. Date of Electronic Publication: 2021 Jul 30.

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Quantification of azacitidine incorporation into human DNA/RNA by accelerator mass spectrometry as direct measure of target engagement.

Autor: Wang X; Celgene, a Wholly Owned Subsidiary of Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, United States. Electronic address: Xiaomin.Wang@bms.com., Vaes WHJ; Nederlandse Organisatie Voor Toegepast Natuurwetenschappelijk Onderzoek (TNO), Zernikedreef 9, 2333 CK, Leiden, the Netherlands., van Duijn E; Nederlandse Organisatie Voor Toegepast Natuurwetenschappelijk Onderzoek (TNO), Zernikedreef 9, 2333 CK, Leiden, the Netherlands., Nooijen I; Nederlandse Organisatie Voor Toegepast Natuurwetenschappelijk Onderzoek (TNO), Zernikedreef 9, 2333 CK, Leiden, the Netherlands., Tong Z; Celgene, a Wholly Owned Subsidiary of Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, United States., de Menezes DL; Celgene, a Wholly Owned Subsidiary of Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, United States., Maxwell SE; Celgene, a Wholly Owned Subsidiary of Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, United States.

Publikováno v: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2021 Aug 05; Vol. 202, pp. 114152. Date of Electronic Publication: 2021 May 19.

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The Oral Bioavailability and Metabolism of Midazolam in Stable Critically Ill Children: A Pharmacokinetic Microtracing Study.

Autor: van Groen BD; Intensive Care and Pediatric Surgery, Erasmus Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands., Krekels EHJ; Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands., Mooij MG; Department of Pediatrics, Leiden University Medical Centre, Leiden, The Netherlands., van Duijn E; TNO, Zeist, The Netherlands., Vaes WHJ; TNO, Zeist, The Netherlands., Windhorst AD; Amsterdam University Medical Centers - Location VU Medical Center, Amsterdam, The Netherlands., van Rosmalen J; Department of Biostatistics, Erasmus Medical Center, Rotterdam, the Netherlands., Hartman SJF; Department of Pharmacology and Toxicology, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands., Hendrikse NH; Amsterdam University Medical Centers - Location VU Medical Center, Amsterdam, The Netherlands., Koch BCP; Department of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands., Allegaert K; Department of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands.; Katholieke Universiteit Leuven, Leuven, Belgium., Tibboel D; Intensive Care and Pediatric Surgery, Erasmus Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands., Knibbe CAJ; Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands.; St Antonius Hospital, Nieuwegein, The Netherlands., de Wildt SN; Intensive Care and Pediatric Surgery, Erasmus Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.; Department of Pharmacology and Toxicology, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Jan; Vol. 109 (1), pp. 140-149. Date of Electronic Publication: 2020 Jun 28.

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