Aleksandra Galetin

2024

Albumin-Mediated Drug Uptake by Organic Anion Transporter 1/3 Is Real: Implications for the Prediction of Active Renal Secretion Clearance

Tan, S. P. F., Tillmann, A., Murby, S. J., Rostami-Hodjegan, A., Scotcher, D. & Galetin, A., 2 Sept 2024, In: Molecular Pharmaceutics. 21, 9, p. 4603 - 4617 15 p.

Research output: Contribution to journal › Article › peer-review

Open Access

Establishing a physiologically-based pharmacokinetic framework for aldehyde oxidase and dual aldehyde oxidase-CYP substrates

Izat, N., Bolleddula , J., Carione, P., Huertas Valentin, L., Jones, R. S., Kulkarni, P., Moss, D., Peterkin, V. C., Tian, D.-D., Treyer, A., Venkatakrishnan, K., Zientek, M. A., Barber, J., Houston, J., Galetin, A. & Scotcher, D., 27 Sept 2024, (Accepted/In press) In: CPT: Pharmacometrics and Systems Pharmacology.

Research output: Contribution to journal › Article › peer-review

Evaluating drug-drug interaction risk associated with peptide analogues using advanced in vitro systems

Nørgaard, R. A., Bhatt, D. K., Järvinen, E., Stage, T. B., Gabel-Jensen, C., Galetin, A. & Säll, C., 1 Sept 2024, In: Drug Metabolism and Disposition. 52, 9

Research output: Contribution to journal › Article › peer-review

Open Access

Facing the facts of altered plasma protein binding: Do current models correctly predict changes in fraction unbound in special populations?

Al Qassabi, J., Tan, P. F. S., Phonboon, P., Galetin, A., Rostami-Hodjegan, A. & Scotcher, D., 26 Feb 2024, (E-pub ahead of print) In: Journal of Pharmaceutical Sciences.

Research output: Contribution to journal › Article › peer-review

Open Access

In silico modeling and simulation of organ-on-a-chip systems to support data analysis and a priori experimental design

Milani, N., Parrott, N., Galetin, A., Fowler, S. & Gertz, M., 1 Apr 2024, In: CPT: Pharmacometrics and Systems Pharmacology. 13, 4, p. 524-543 20 p.

Research output: Contribution to journal › Article › peer-review

Open Access

2023

Challenges and opportunities for in vitro-in vivo extrapolation of aldehyde oxidase-mediated clearance: Towards a roadmap for quantitative translation

Izat, N., Bolleddula, J., Abbasi, A., Cheruzel, L., Jones, R., Moss, D., Ortega-Muro, F., Parmentier, Y., Peterkin, V. C., Tian, D.-D., Venkatakrishnan, K., Zientek, M., Barber, J., Houston, J., Galetin, A. & Scotcher, D., 28 Aug 2023, (Accepted/In press) In: Drug Metabolism and Disposition.

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Development of 4-Pyridoxic Acid PBPK Model to Support Biomarker- Informed Evaluation of OAT1/3 Inhibition and Effect of Chronic Kidney Disease

Tan, S. P. F., Willemin, M., Snoeys, J., Shen, H., Rostami‐hodjegan, A., Scotcher, D. & Galetin, A., 24 Aug 2023, (E-pub ahead of print) In: Clinical Pharmacology & Therapeutics.

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Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug-Drug Interactions in Children

Cleary, Y., Kletzl, H., Grimsey, P., Heinig, K., Ogungbenro, K., Silber Baumann, H. E., Frey, N., Aarons, L., Galetin, A. & Gertz, M., 1 Jun 2023, In: Clinical Pharmacokinetics. 62, 6, p. 891-904 14 p.

Research output: Contribution to journal › Article › peer-review

Open Access

Use of In Vivo Imaging and Physiologically-Based Kinetic Modelling to Predict Hepatic Transporter Mediated Drug–Drug Interactions in Rats

Melillo, N., Scotcher, D., Kenna, J. G., Green, C., Hines, C. D. G., Laitinen, I., Hockings, P. D., Ogungbenro, K., Gunwhy, E. R., Sourbron, S., Waterton, J. C., Schuetz, G. & Galetin, A., 10 Mar 2023, In: Pharmaceutics. 15, 3, 25 p., 896.

Research output: Contribution to journal › Article › peer-review

Open Access

2022

Application of a gut-liver-on-a-chip device and mechanistic modelling to the quantitative in vitro pharmacokinetic study of mycophenolate mofetil

Milani, N., Parrott, N., Ortiz Franyuti, D., Godoy, P., Galetin, A., Gertz, M. & Fowler, S., 26 Jul 2022, In: Lab on a Chip. 22, 15, p. 2853-2868 16 p.

Research output: Contribution to journal › Article › peer-review

Clinical implications of altered drug transporter abundance/function and PBPK modeling in specific populations: An ITC perspective

Chu, X., Prasad, B., Neuhoff, S., Yoshida, K., Leeder, J. S., Mukherjee, D., Taskar, K., Varma, M. V., Zhang, X., Yang, X. & Galetin, A., 13 May 2022, (E-pub ahead of print) In: Clinical Pharmacology & Therapeutics.

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Coproporphyrin I as an endogenous biomarker to detect reduced OATP1B activity and shift in elimination route in chronic kidney disease

Takita, H., Scotcher, D., Chu, X., Yee, K. L., Ogungbenro, K. & Galetin, A., 2 Jun 2022, In: Clinical Pharmacology & Therapeutics.

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Effect of chronic kidney disease on the renal secretion via organic anion transporters (OAT)1/3: Implications for PBPK modelling and dose adjustment

Tan, S. P. F., Scotcher, D., Rostami‐hodjegan, A. & Galetin, A., 15 May 2022, In: Clinical Pharmacology & Therapeutics.

Research output: Contribution to journal › Article › peer-review

Open Access

Exploration and application of a liver-on-a-chip device in combination with modelling and simulation for quantitative drug metabolism studies

Docci, L., Milani, N., Ramp, T., Romeo, A. A., Godoy, P., Franyuti, D. O., Krähenbühl, S., Gertz, M., Galetin, A., Parrott, N. & Fowler, S., 25 Jan 2022, In: Lab on a Chip. 22, 6, p. 1187-1205 19 p.

Research output: Contribution to journal › Article › peer-review

Open Access

2021

Clinical Investigation on Endogenous Biomarkers to Predict Strong OAT-Mediated Drug–Drug Interactions

Willemin, M.-E., Van Der Made, T. K., Pijpers, I., Dillen, L., Kunze, A., Jonkers, S., Steemans, K., Tuytelaars, A., Jacobs, F., Monshouwer, M., Scotcher, D., Rostami-hodjegan, A., Galetin, A. & Snoeys, J., 10 Apr 2021, In: Clinical Pharmacokinetics.

Research output: Contribution to journal › Article › peer-review

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Impact of Hepatic CYP3A4 Ontogeny Functions on Drug-Drug Interaction Risk in Pediatric Physiologically-Based Pharmacokinetic/Pharmacodynamic Modeling: Critical Literature Review and Ivabradine Case Study

Lang, J., Vincent, L., Chenel, M., Ogungbenro, K. & Galetin, A., Jun 2021, In: Clinical Pharmacology & Therapeutics. 109, 6, p. 1618-1630 13 p.

Research output: Contribution to journal › Article › peer-review

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PBPK Model of Coproporphyrin I: Evaluation of the Impact of SLCO1B1 Genotype, Ethnicity, and Sex on its Inter-Individual Variability

Takita, H., Barnett, S., Zhang, Y., Ménochet, K., Shen, H., Ogungbenro, K. & Galetin, A., Feb 2021, In: CPT: Pharmacometrics and Systems Pharmacology. 10, 2, p. 137-147 11 p.

Research output: Contribution to journal › Article › peer-review

Open Access

PBPK simulation-based evaluation of ganciclovir crystalluria risk factors: effect of renal impairment, old age and low fluid intake

Scotcher, D. & Galetin, A., 2021, In: AAPS Journal.

Research output: Contribution to journal › Article › peer-review

Physiologically Based Pharmacokinetic Modeling of TransporterMediated Hepatic Disposition of Imaging Biomarker Gadoxetate in Rats

Scotcher, D., Melillo, N., Tadimalla, S., Darwich, A., Ziemian, S., Ogungbenro, K., Schutz, G., Sourbron, S. & Galetin, A., 2 Aug 2021, In: Molecular Pharmaceutics. 18, 8, p. 2997-3009 13 p.

Research output: Contribution to journal › Article › peer-review

Physiologically-based pharmacokinetic modelling of transporter-mediated hepatic disposition of 1 imaging biomarker gadoxetate in rats

Scotcher, D., Melillo, N., Tadimalla, S., Darwich, A., Ziemian, S., Ogungbenro, K., Schütz, G., Sourbron, S. P. & Galetin, A., 2021, In: Molecular Pharmaceutics.

Research output: Contribution to journal › Article › peer-review

Population pharmacokinetic modeling and simulation to support qualification of pyridoxic acid as endogenous biomarker of OAT1/3 renal transporters

Ahmad, A., Ogungbenro, K., Kunze, A., Jacobs, F., Snoeys, J., Rostami‐hodjegan, A. & Galetin, A., 1 May 2021, In: CPT: Pharmacometrics and Systems Pharmacology. 10, 5, p. 467-477

Research output: Contribution to journal › Article › peer-review

Open Access

Quantitative Proteomic Map of Enzymes and Transporters in the Human Kidney: Stepping Closer to Mechanistic Kidney Models to Define Local Kinetics

Al-Majdoub, Z., Scotcher, D., Achour, B., Barber, J., Galetin, A. & Rostami-Hodjegan, A., 1 Nov 2021, In: Clinical Pharmacology & Therapeutics. 110, 5, p. 1389-1400 12 p.

Research output: Contribution to journal › Article › peer-review

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Reduced physiologically-based pharmacokinetic model of dabigatran etexilate-dabigatran and its application for prediction of intestinal P-gp-mediated drug-drug interactions

Lang, J., Vincent, L., Chenel, M., Ogungbenro, K. & Galetin, A., 1 Oct 2021, In: European Journal of Pharmaceutical Sciences. 165, 14 p., 105932.

Research output: Contribution to journal › Article › peer-review

2020

A novel physiologically based model of creatinine renal disposition to integrate current knowledge of systems parameters and clinical observations

Scotcher, D., Arya, V., Yang, X., Zhao, P., Zhang, L., Huang, S.-M., Rostami-Hodjegan, A. & Galetin, A., 22 May 2020, In: CPT: Pharmacometrics and Systems Pharmacology.

Research output: Contribution to journal › Article › peer-review

Open Access

Intestinal P‐gp and Putative Hepatic OATP1B Induction: ITC Perspective on Drug Development Implications

Zamek-Gliszczynski, M. J., Patel, M., Yang, X., Lutz, J. D., Chu, X., Brouwer, K. L. R., Lai, Y., Lee, C. A., Neuhoff, S., Paine, M. F., Sugiyama, Y., Taskar, K. S. & Galetin, A., 2020, In: Clinical Pharmacology & Therapeutics.

Research output: Contribution to journal › Article › peer-review

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Mechanistic models as framework for understanding biomarker disposition: Prediction of creatinine-drug interactions

Scotcher, D., Arya, V., Yang, X., Zhao, P., Zhang, L., Huang, S.-M., Rostami-Hodjegan, A. & Galetin, A., 14 May 2020, In: CPT: Pharmacometrics and Systems Pharmacology. 9, 5, p. 282-293 12 p.

Research output: Contribution to journal › Article › peer-review

Open Access

Physiologically-based Pharmacokinetic Modelling of Creatinine-drug Interactions in the Chronic Kidney Disease Population

Takita, H., Scotcher, D., Chinnadurai, R., Kalra, P. & Galetin, A., 13 Oct 2020, In: CPT: Pharmacometrics and Systems Pharmacology. 9, 12, p. 695-706 12 p.

Research output: Contribution to journal › Article › peer-review

Open Access

Simultaneous Ivabradine Parent-Metabolite PBPK/PD modelling using a Bayesian estimation method

Lang, J., Vincent, L., Chenel, M., Ogungbenro, K. & Galetin, A., 18 Aug 2020, (Accepted/In press) In: AAPS Journal.

Research output: Contribution to journal › Article › peer-review

Utilising magnetically isolated lysosomes for direct quantification of intralysosomal drug concentrations by LC MS/MS analysis: An investigatory study with imipramine

Francis, L., Harrell, A., Hallifax, D. & Galetin, A., 1 Sept 2020, In: Journal of Pharmaceutical Sciences. 109, 9, p. 2891-2901

Research output: Contribution to journal › Article › peer-review

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2019

A population pharmacokinetic model for simvastatin and its metabolites in children and adolescents

Ogungbenro, K., Wagner, J. B., Abdel-Rahman, S., Leeder, J. S. & Galetin, A., 2019, In: European journal of clinical pharmacology.

Research output: Contribution to journal › Article › peer-review

Open Access

Comprehensive evaluation of the utility of 20 endogenous molecules as biomarkers of OATP1B inhibition compared to rosuvastatin and coproporphyrin I

Barnett, S., Ogungbenro, K., Menochet, K., Shen, H., Humphreys, G. W. & Galetin, A., 1 Jan 2019, In: Journal of Pharmacology and Experimental Therapeutics. 368, 1, p. 125-135 11 p.

Research output: Contribution to journal › Article › peer-review

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Quantitative translation of microfluidic transporter in vitro data to in vivo reveals impaired albumin-facilitated indoxyl sulfate secretion in chronic kidney disease

Van Der Made, T. K., Fedecostante, M., Scotcher, D., Rostami-hodjegan, A., Sastre Torano, J., Middel, I., Koster, A. S., Gerritsen, K. G., Jankowski, V., Jankowski, J., Hoenderop, J. G. J., Masereeuw, R. & Galetin, A., 16 Sept 2019, In: Molecular Pharmaceutics. 16, 11, p. 4551–4562

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2018

Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches

Guo, Y., Chu, X., Parrott, N. J., Brouwer, K. L. R., Hsu, V., Nagar, S., Matsson, P., Sharma, P., Snoeys, J., Sugiyama, Y., Tatosian, D., Unadkat, J. D., Huang, S.-M. & Galetin, A., 22 Oct 2018, In: Clinical Pharmacology & Therapeutics. 104, 5, p. 865-889

Research output: Contribution to journal › Article › peer-review

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Clinical Probes and Endogenous Biomarkers as Substrates for Transporter Drug-Drug Interaction Evaluation: Perspectives From the International Transporter Consortium

Chu, X., Liao, M., Shen, H., Yoshida, K., Zur, A. A., Arya, V., Galetin, A., Giacomini, K. M., Hanna, I., Kusuhara, H., Lai, Y., Rodrigues, D., Sugiyama, Y., Zamek-gliszczynski, M. J. & Zhang, L., Nov 2018, In: Clinical Pharmacology & Therapeutics. 104, 5, p. 836-864

Research output: Contribution to journal › Article › peer-review

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Dabigatran Etexilate and Digoxin: Comparison as Clinical Probe Substrates for Evaluation of P-gp Inhibition

Chu, X., Galetin, A., Zamek-gliszczynski, M. J., Zhang, L. & Tweedie, D. J., 1 Nov 2018, In: Clinical Pharmacology & Therapeutics. 104, 5, p. 788-792

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Gaining mechanistic insight into coproporphyrin I as endogenous biomarker for OATP1B-mediated drug-drug interactions using population pharmacokinetic modelling and simultion

Barnett, S., Ogungbenro, K., Menochet, K., Shen, H., Humphreys, W. G. & Galetin, A., 2018, In: Clinical Pharmacology & Therapeutics. p. 1-26

Research output: Contribution to journal › Article › peer-review

Open Access

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Hepatic OATP-mediated clearance in the Beagle dog: assessing in vitro-in vivo relationships and applying cross species empirical scaling factors to improve prediction of human clearance

Matsunaga, N., Ufuk, A., Morse, B. L., Bedwell, D. W., Bao, J., Mohutsky, M. A., Hillgren, K. M., Hall, S. D., Houston, J. B. & Galetin, A., 28 Dec 2018, In: Drug Metabolism and Disposition. 47, 3, p. 215-226 12 p.

Research output: Contribution to journal › Article › peer-review

Influence of Transporter Polymorphisms on Drug Disposition and Response: A Perspective From the International Transporter Consortium

Yee, S. W., Brackman, D. J., Ennis, E. A., Sugiyama, Y., Kamdem, L. K., Blanchard, R., Galetin, A., Zhang, L. & Giacomini, K. M., 2018, In: Clinical Pharmacology and Therapeutics.

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In Vitro-ln Vivo Extrapolation of OATP1B-Mediated Drug-Drug Interactions in Cynomolgus Monkey

Ufuk, A., Kosa, R. E., Gao, H., Bi, Y. A., Modi, S., Gates, D., Rodrigues, A. D., Tremaine, L. M., Varma, M. V. S., Houston, J. B. & Galetin, A., 1 Jun 2018, In: Journal of Pharmacology and Experimental Therapeutics. 365, 3, p. 688-699 12 p.

Research output: Contribution to journal › Article › peer-review

ITC Commentary on Metformin Clinical Drug-Drug Interaction Study Design That Enables an Efficacy- and Safety-Based Dose Adjustment Decision

Zamek-Gliszczynski, M. J., Chu, X., Cook, J. A., Custodio, J. M., Galetin, A., Giacomini, K. M., Lee, C. A., Paine, M. F., Ray, A. S., Ware, J. A., Wittwer, M. B. & Zhang, L., 2018, In: Clinical Pharmacology and Therapeutics.

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Predicting human clearance of organic anion transporting polypeptide substrates using cynomolgus monkey: In vitro-in vivo scaling of hepatic uptake clearance

De Bruyn, T., Ufuk, A., Cantrill, C., Kosa, R. E., Bi, Y. A., Niosi, M., Modi, S., Rodrigues, A. D., Tremaine, L. M., Varma, M. V. S., Galetin, A. & Houston, J. B., Jul 2018, In: Drug Metabolism and Disposition. 46, 7, p. 989-1000 12 p.

Research output: Contribution to journal › Article › peer-review

The International Transporter Consortium: Summarizing Advances in the Role of Transporters in Drug Development

Giacomini, K. M., Galetin, A. & Huang, S. M., 22 Oct 2018, In: Clinical Pharmacology & Therapeutics. 104, 5, p. 766-771

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Towards Further Verification of Physiologically-Based Kidney Models: Predictability of the Effects of Urine-Flow and Urine-pH on Renal Clearance

Matsuzaki, T., Scotcher, D., Darwich, A., Galetin, A. & Rostami-hodjegan, A., 2018, In: Journal of Pharmacology and Experimental Therapeutics.

Research output: Contribution to journal › Article › peer-review

Open Access

Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Effect of Chronic Kidney Disease on the Disposition of Hepatic CYP2C8 and OATP1B Drug Substrates

Tan, M.-L., Zhao, P., Zhang, L., Ho, Y.-F., Varma, M. V. S., Neuhoff, S., Nolin, T. D., Galetin, A. & Huang, S.-M., 2018, In: Clinical Pharmacology & Therapeutics.

Research output: Contribution to journal › Article › peer-review

Open Access

2017

Delineating the role of various factors in renal disposition of digoxin through application of physiologically-based kidney model to renal impairment populations

Scotcher, D., Jones, C., Galetin, A. & Rostami-Hochaghan, A., Mar 2017, In: Journal of Pharmacology and Experimental Therapeutics. 360, 3, p. 484-495 12 p.

Research output: Contribution to journal › Article › peer-review

Open Access

Effect of Chronic Kidney Disease on Nonrenal Elimination Pathways: A Systematic Assessment of CYP1A2, CYP2C8, CYP2C9, CYP2C19, and OATP

Tan, M. L., Yoshida, K., Zhao, P., Zhang, L., Nolin, T. D., Piquette-Miller, M., Galetin, A. & Huang, S. M., 2017, In: Clinical Pharmacology and Therapeutics.

Research output: Contribution to journal › Article › peer-review

Open Access

IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes

Darwich, A., Aarons, L., Galetin, A., Rostami-Hochaghan et al, A., Margolskee, A., Pepin, X., Carlert, S., Hammarberg, M., Hilgendorf, C., Johansson, P., Karlsson, E., Murphy, D., Tannergren, C., Thorn, H., Yasin, M., Mazuir, F., Nicolas, O., Ramusovic, S., Xu, C. & Pathak, S. & 43 others, Korjamo, T., Laru, J., Malkki, J., Pappinen, S., Tuunainen, J., Dressman, J., Hansmann, S., Kostewicz, E. S., He, H., Heimbach, T., Wu, F., Hoft, C., Pang, Y., Bolger, M., Huehn, E., Heimbach, T., Wu, F., Hoft, C., Pang, Y., Bolger, M. B., Huehn, E., Lukacova, V., Mullin, J. M., Szeto, K. X., Costales, C., Lin, J., McAllister, M., Modi, S., Rotter, C., Varma, M., Wong, M., Mitra, A., Bevernage, J., Biewenga, J., Peer, A. V., Lloyd, R., Shardlow, C., Langguth, P., Mishenzon, I., Nguyen, M. A., Brown, J., Lennerans, H. & Abrahmsson, B., 1 Jan 2017, In: European Journal of Pharmaceutical Sciences. 96, p. 626-642 17 p.

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Incorporation of lysosomal sequestration in the mechanistic model for prediction of tissue distribution of basic drugs

Assmus, F., Houston, J. & Galetin, A., 2017, In: European Journal of Pharmaceutical Sciences.

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In vitro and in silico tools to assess extent of cellular uptake and lysosomal sequestration of respiratory drugs in human alveolar macrophages

Ufuk, A., Assmus, F., Francis, L., Plumb, J., Damian, V., Gertz, M., Houston, J. & Galetin, A., 20 Mar 2017, In: Molecular Pharmaceutics. 14, 4, p. 1033–1046

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In Vitro-In Vivo Extrapolation of Metabolism- and Transporter-Mediated Drug-Drug Interactions - Overview of Basic Prediction Methods

Yoshida, K., Zhao, P., Zhang, L., Abernethy, D. R., Rekić, D., Reynolds, K. S., Galetin, A. & Huang, S.-M., 2017, In: Journal of Pharmaceutical Sciences. 106, 9, p. 2209-2213

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Aleksandra Galetin

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