PBPK & PBBM consulting services

Way of working

Benefits

Allow for scenarios beyond those observed

The independent representations of drug, biological entities and system parameters in PBPK-PBBM models allow for extrapolation to scenarios beyond those observed. We see the main benefits with applying PBPK-PBBM analyses as the following:

Distinctively addresses how a drug is absorbed, distributed, and eliminated, which allows for better understanding of each process and their respective association to drugs exposure and dynamics.
Via biopharmaceutics and administration route specific absorption models provide basis for optimized drug delivery, drug formulation and dosing strategies to improve drug performance and decisions in bridging.
PBPK facilitates predictions of drug concentration at the site of pharmacological action. Combined with a model representing pharmacological response this provides a holistic and mechanistic understanding of the concentration/response relationship(s) of drugs in patients.
Common translational applications for PBPK-PBBM modeling are First-In-Human trials support, biopharmaceutics and virtual bioequivalence (VBE) assessments, drug-drug interactions (DDI), special populations, like pediatrics and organ, or early prediction of clinical efficacy.

Tools

Examples of our work

Featured affiliated publications

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

18.09.24

Bioavailability of a novel sustained-release pellet formulation of 5-flucytosine in healthy-fed participants for use in patients with cryptococcal meningitis

PBPK & PBBM

Infectious Diseases

Clin Transl Sci. 2024; 17:e13908

Ibnou Zekri Lassout N, Goyal V, Krantz E, Simon F, Neven A, Eriksson J, Saayman A, Satam V, Ruffell C, Victor S, Chenel M, Celebic A, Caplain H, Gillon J-Y, Deshmukh A, Antarkar A, Sjögren E, Ribeiro I

16.09.24

PBPK modeling of recombinant factor IX Fc fusion protein (rFIXFc) and rFIX to characterize the binding to type 4 collagen in the extravascular space

PBPK & PBBM

Hematology

CPT Pharmacometrics Syst Pharmacol. 2024 Sep 16.

Cloesmeijer ME, Sjögren E, Koopman SF, Lenting PJ, Cnossen MH, Mathôt RAA; OPTI‐CLOT study group and SYMPHONY consortium.

10.05.24

Skin pharmacokinetics of miltefosine in the treatment of post-kala-azar dermal leishmaniasis in South Asia

PBPK & PBBM

Infectious Diseases

J Antimicrob Chemother. 2024 Jul 1;79(7):1547-1554.

Palić S, Chu WY, Sundar S, Mondal D, Das P, Pandey K, Raja S, Rijal S, Roseboom IC, Hamadeh A, Malik PRV, Beijnen JH, Huitema ADR, Sjögren E, Alves F, Dorlo TPC.

Way of working

Tools

Examples of our work

Featured affiliated publications

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