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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

07.05.25

Paediatric pharmacokinetic-pharmacodynamic extrapolation to identify suitable bulevirtide doses for children and adolescents with chronic hepatitis delta

MIDD

Trial design and analysis

Regulatory interactions

Pharmacometrics

Infectious Diseases

J Hepatol 82:S823

Kumar P, Mc Laughlin AM, Velez de Mendizabal N, Caro L, Kersey K, Iglesias-Lopez C, Koziara J, Ruiz-Garcia A

29.04.25

The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models

MIDD

Pharmacometrics

Methodology

AAPS J. 2025 Apr 29;27(4):86.

Ibrahim MMA, Jonsson EN, Bergstrand M

03.04.25

Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference

PBPK & PBBM

QSP

Pharmacometrics

CPT Pharmacometrics Syst Pharmacol. 2025 May;14(5):822-827.

Dallmann A, Feick D, Balazki P, Benamara S, Burghaus R, Chenel M, Choi SL, Cordes H, Guimarães M, Hamadeh A, Ince I, Job KM, Kanacher T, Kovar A, Kuepfer L, Lippert J, Macente J, Nauwelaerts N, Niederalt C, Peters S, Proença S, Sato M, Schaller S, Schlender JF, Schneider A, Sjögren E, Solodenko J, Staab A, Vrenken P, Wendl T, de Witte WEA, Teutonico D

10.03.25

Exposure‐tumour growth inhibition modelling of brigimadlin using phase I solid tumour data to support phase II dose selection

Oncology

MIDD

Pharmacometrics

Program strategies and efficiencies

Br J Clin Pharmacol. 2025 Mar.

Neldemo I, Gausi K, Sarr C, Friberg LE, Sailer R, Lahmar M, Jayadeva G, Pérez-Pitarch A, Schmid U, Busse D.

01.03.25

Assessing Drug–Drug Interaction and Food Effect for BCS Class 2 Compound BI 730357 (Retinoic Acid-Related Orphan Receptor Gamma Antagonist, Bevurogant) Using a Physiology-Based Pharmacokinetics Modeling (PBPK) Approach with Semi-Mechanistic Absorption

PBPK & PBBM

Immunology

Regulatory interactions

Pharmaceutics 2025, 17(3), 314;

Kanacher T, Sjögren E, Korell J, Plan EL, Gómez-Mantilla JD, Ince I.

25.02.25

Model-informed drug development of a sustained release formulation of flucytosine in the treatment of cryptococcal meningitis: a case study using physiologically based pharmacokinetic modeling

PBPK & PBBM

MIDD

Specific populations

Infectious Diseases

Program strategies and efficiencies

CPT Pharmacometrics Syst Pharmacol. 2025 Feb 25.

Eriksson J, Sjögren E, Gillon JY, Caplain H, Goyal V, Satam V, Robinson S, Ribeiro I, Chenel M

22.02.25

The impact of misspecified covariate models on inclusion and omission bias when using fixed effects and full random effects models

Pharmacometrics

Methodology

J Pharmacokinet Pharmacodyn. 2025 Feb 22;52(2):18.

Nyberg J, Jonsson EN

21.01.25

Pharmacokinetic characterization and exposure–response relationship of crovalimab in the COMMODORE 1, 2 and 3 and COMPOSER trials of patients with paroxysmal nocturnal haemoglobinuria

MIDD

Trial design and analysis

Pharmacometrics

Genetic

Hematology

Br J Clin Pharmacol. 2025 Jan 21.

Cosson V, Fu R, Kulasekararaj A, Nishimura J-I, Panse J, Röth A, Scheinberg P, Tong H, Yoon S-S, Beveridge L, Gotanda K, Jaminion F, Henrich A, Lundberg P, Shi D, Sreckovic S, Zhang Y, Zhang Z, Benkali K, Buatois S

1 …91011… 34

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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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