Population pharmacokinetics of durvalumab in cancer patients and association with longitudinal biomarkers of disease status

PG Baverel, VFS Dubois, CY Jin… - Clinical …, 2018 - Wiley Online Library
The objectives of this analysis were to develop a population pharmacokinetics (PK) model of
durvalumab, an anti‐PD‐L1 antibody, and quantify the impact of baseline and time‐varying …

Efficient and relevant stepwise covariate model building for pharmacometrics

RJ Svensson, EN Jonsson - CPT: pharmacometrics & systems …, 2022 - Wiley Online Library
Covariate modeling is an important opportunity for pharmacometrics to influence decision
making in drug development. The stepwise covariate model (SCM) building procedure is the …

Imeglimin population pharmacokinetics and dose adjustment predictions for renal impairment in Japanese and Western patients with type 2 diabetes

Y Tomita, E Hansson, F Mazuir… - Clinical and …, 2022 - Wiley Online Library
Imeglimin is an orally administered first‐in‐class drug to treat type 2 diabetes mellitus
(T2DM) and is mainly excreted unchanged by the kidneys. The present study aimed to …

Exposure‐response analysis after subcutaneous administration of RBP‐7000, a once‐a‐month long‐acting Atrigel formulation of risperidone

V Ivaturi, M Gopalakrishnan… - British journal of …, 2017 - Wiley Online Library
Aims A new, long‐acting, subcutaneous (SC) formulation of risperidone (RBP‐7000) has
been developed for the treatment of schizophrenia to address issues of non‐adherence …

Characterization of an in vivo concentration-effect relationship for piperaquine in malaria chemoprevention

M Bergstrand, F Nosten, KM Lwin… - Science translational …, 2014 - science.org
A randomized, placebo-controlled trial conducted on the northwest border of Thailand
compared malaria chemoprevention with monthly or bimonthly standard 3-day treatment …

Rituximab pharmacokinetic and pharmacokinetic–pharmacodynamic evaluation based on a study in diffuse large B‐cell lymphoma: Influence of tumor size on …

RJ Svensson, QX Ooi, LE Friberg… - CPT …, 2023 - Wiley Online Library
Abstract Dr. Reddy's Laboratories rituximab (DRL_RI; Dr. Reddy's Laboratories SA, Basel,
Switzerland) is under development as a rituximab biosimilar. Study RI‐01‐002 (Clinical …

An evaluation of overall survival in patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure

S Lin, N Shaik, G Chan, JE Cortes… - Cancer chemotherapy and …, 2020 - Springer
Purpose Glasdegib, an oral inhibitor of the Hedgehog signaling pathway, is approved in the
United States in combination with low-dose cytarabine (LDAC) to treat patients with newly …

Population repeated time‐to‐event analysis of exacerbations in asthma patients: a novel approach for predicting asthma exacerbations based on biomarkers …

RJ Svensson, J Ribbing, N Kotani… - CPT …, 2021 - Wiley Online Library
Identification of covariates, including biomarkers, spirometry, and diaries/questionnaires,
that predict asthma exacerbations would allow better clinical predictions, shorter phase II …

Population pharmacokinetics of tenecteplase in patients with acute myocardial infarction and application to patients with acute ischemic stroke

F Tang, J Langenhorst, S Dang, N Kassir… - The Journal of …, 2023 - Wiley Online Library
The pharmacokinetics (PK) of tenecteplase in patients with acute ischemic stroke has not
been extensively studied. This study aimed to describe PK characteristics of tenecteplase in …

Application of Mixed-Effect Modeling to Improve Mechanistic Understanding and Predictability of Oral Absorption

M Bergstrand - 2011 - diva-portal.org
The oral route is and will for, a foreseeable future, be the by far most common way of
administering pharmacological substances. This is natural given the convenience that it …