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  2. Publications

Publications

Below we provide links to posters, white papers and scientific publications by Pharmetheus affiliates in chronological order. Please note that access to some publications may require a subscription.

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Publications

08.12.20

Population RTTE Analysis of Exacerbations in Asthma Patients: a Novel Approach for Predicting Asthma Exacerbations Based on Biomarkers, Spirometry and Diaries/Questionnaires

Pharmacometrics

Respiratory

ACoP11, ISSN:2688-3953, 2020, Vol 2.

Svensson RJ, Ribbing J, Kotani N, Dolton M, Vadhavkar S, Cheung D, Staton T, Choy DF, Putnam W, Jin J, Budha N, Karlsson MO, Quartino A, Zhu R

01.11.20

Pharmacokinetic Modelling and Simulation Support the Age and Body-Weight-Adjusted Dosing of Dabigatran Etexilate in Paediatric Patients with Venous Thromboembolism, PB1271

MIDD

Specific populations

Pharmacometrics

Hematology

Res Pract Thromb Haemost. 2020 Jul;4(Suppl 1):1-1311.

Röshammar D, Huang F, Albisetti M, Bomgaars L, Chalmers E, Luciani M, Halton J, Mitchell L, Joseph D, Tartakovsky I, Gropper S, Reilly P, Brueckmann M, Brandão L, on Behalf of the Study Investigators

30.10.20

In Vitro Biopredictive Methods: A Workshop Summary Report

PBPK & PBBM

J Pharm Sci. 2021 Feb;110(2):567-583.

Pepin X, Dressman J, Parrott N, Delvadia P, Mitra A, Zhang X, Babiskin A, Kolhatkar V, Seo P, Taylor L, Sjögren E, Butler J, Kostewicz E, Tannergren C, Koziolek M, Kesisoglou F, Dallmann A, Zhao Y, Suarez-Sharp S

01.08.20

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

PBPK & PBBM

Regulatory interactions

J Pharm Sci. 2021 Feb;110(2):594-609.

Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A

01.07.20

Clinical Trial Simulation To Optimize Trial Design for Fludarabine Dosing Strategies in Allogeneic Hematopoietic Cell Transplantation

Oncology

Trial design and analysis

Pharmacometrics

Hematology

CPT Pharmacometrics Syst Pharmacol. 2020 May;9(5):272-281.

Langenhorst J, Dorlo TPC, van Kesteren C, van Maarseveen E, Nierkens S, de Witte MA, Boelens JJ, Huitema ADR

01.05.20

A Semi-Mechanistic Model Based on Glutathione Depletion to Describe Intra-Individual Reduction in Busulfan Clearance

Oncology

Pharmacometrics

Hematology

Br J Clin Pharmacol. 2020 Aug;86(8):1499-1509.

Langenhorst J, Boss J, van Kesteren C, Lalmohamed A, Kuball J, Egberts ACG, Boelens JJ, Huitema ADR, van Maarseveen EM

02.02.20

[1] A Physiologically-Based Pharmacokinetic (PBPK) Model Network for the Prediction of CYP1A2 and CYP2C19 Drug-Drug-Gene Interactions with Fluvoxamine, Omeprazole, S-mephenytoin, Moclobemide, Tizanidine, Mexiletine, Ethinylestradiol, and Caffeine

PBPK & PBBM

Pharmaceutics. 2020 Dec 8;12(12):1191.

Kanacher T, Lindauer A, Mezzalana E, Michon I, Veau C, Mantilla JD, Nock V, Fleury A.

02.02.20

Model Informed Drug Development: Collaboration Through A Common Framework

MIDD

Clin Pharmacol Ther. 2021 Nov;110(5):1165-1167.

Anziano RJ, Milligan PA

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Pharmetheus is a consultancy firm helping clients reduce uncertainty in technical and regulatory processes, increasing confidence in the development of new medicines that can improve patients’ lives.

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