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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.

Search publications

Publications

11.06.19

Open Systems Pharmacology Community-An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences

PBPK & PBBM

CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):878-882.

Lippert J, Burghaus R, Edginton A, Frechen S, Karlsson M, Kovar A, Lehr T, Milligan PA, Nock V, Ramusovic S, Riggs M, Schaller S, Schlender J, Schmidt S, Sevestre M, Sjögren E, Solodenko J, Staab A, Teutonico D

11.06.19

Assessment of Expected Drug Exposure Relative Maximum Safety Limits in Early Phase Studies

MIDD

Trial design and analysis

Pharmacometrics

Program strategies and efficiencies

PAGE 28 (2019) Abstr 9159.

Kristoffersson A, Röshammar D, Plan EL

11.06.19

Competing Risks Analysis of the Finnish Diabetes Prevention Study

Endocrinology

Pharmacometrics

Metabolism

PAGE 28 (2019) Abstr 9033.

Ibrahim MMA, de Mello VD, Uusitupa M, Tuomilehto J, Lindström J, Kjellsson MC, Karlsson MO

11.06.19

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report

PBPK & PBBM

Regulatory interactions

Program strategies and efficiencies

AAPS J. 2019 Feb 11;21(2):29.

Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, Sjögren E, Tsakalozou E, Seo P, Li M, Zhang X, Lin HP, Montague T, Mitra A, Morris D, Patel N, Kesisoglou F

11.06.19

Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies

Pharmacometrics

Hematology

AAPS J. 2019 Jul 8;21(5):85.

Brekkan A, Lopez-Lazaro L, Plan EL, Nyberg J, Kankanwadi S, Karlsson MO

11.06.19

Model Based Support to Biosimilarity Assessment Planning – A Case Study of Pegfilgrastim

Pharmacometrics

Hematology

PAGE 28 (2019) Abstr 9166.

Brekkan A, Lopez-Lazaro L, Plan EL, Acharya C, Yngman G, Nyberg J, Hooker AC, Kankanwadi S, Karlsson MO

01.02.19

Caplacizumab Dosing Rational in aTTP Patients Supported by Mechanism Based PKPD Modelling

MIDD

Specific populations

Pharmacometrics

Hematology

PAGE 28 (2019) Abstr 8800.

Bergstrand M, Hansson E, Sargentini-Maier ML

01.09.18

The Standard Output: A Tool-Agnostic Modeling Storage Format

CPT Pharmacometrics Syst Pharmacol. 2018 Sep;7(9):543-546.

Terranova N, Smith MK, Nordgren R, Comets E, Lavielle M, Harling K, Hooker AC, Sarr C, Mentré F, Yvon F, Swat MJ

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About Pharmetheus

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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