Population Pharmacokinetic Modeling and Exposure‐Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1022
Abstract: An intramuscular formulation of aripiprazole monohydrate dosed once monthly (AOM) was developed to address nonadherence with the approved oral tablets. A 3‐compartment linear population pharmacokinetic model for oral and AOM doses was developed; relative bioavailability… read more here.
Keywords: population pharmacokinetic; population; exposure response; metabolizer status ... See more keywords
Population Pharmacokinetic/Pharmacodynamic and Exposure‐Response Modeling Analyses of Sotatercept in Healthy Participants and Patients with Pulmonary Arterial Hypertension
Sign Up to like & getrecommendations! Published in 2024 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.3524
Abstract: Sotatercept is a breakthrough, first‐in‐class biologic, recently approved by the Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). Exposure‐response (E‐R) analyses and pharmacokinetic/pharmacodynamic (PK/PD) modeling were performed for sotatercept after… read more here.
Keywords: arterial hypertension; pharmacokinetic pharmacodynamic; exposure response; pulmonary arterial ... See more keywords
Addressing Causality and Homogeneity Assumptions in Exposure-Response Analyses.
Sign Up to like & getrecommendations! Published in 2025 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.70132
Abstract: Exposure-response, or pharmacokinetic-pharmacodynamic (PKPD), analyses support many drug development decisions. It is typically applied without assessment of causality and homogeneity, where the latter refers to the assumption that the reason for variability in exposure is… read more here.
Keywords: causality homogeneity; response; exposure response; model ... See more keywords
Strategies for Optimizing Traditional Exposure and Response Prevention: A Case Study Example in an Adolescent With Contamination-Based OCD.
Sign Up to like & getrecommendations! Published in 2024 at "Journal of clinical psychology"
DOI: 10.1002/jclp.23758
Abstract: Cognitive Behavioral Therapy (CBT) with an emphasis on Exposure and Response Prevention (ERP) has consistently been observed to be an efficacious treatment for obsessive-compulsive disorder (OCD). Although ERP is currently considered the gold-standard, first-line psychological… read more here.
Keywords: response prevention; exposure; exposure response; case study ... See more keywords
Population Pharmacokinetics and Exposure‐Response Analyses for CPX‐351 in Patients With Hematologic Malignancies
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Clinical Pharmacology"
DOI: 10.1002/jcph.1366
Abstract: CPX‐351, a dual‐drug liposomal encapsulation of cytarabine and daunorubicin at a synergistic ratio, is approved in the United States for adults with newly diagnosed therapy‐related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia‐related changes.… read more here.
Keywords: cpx 351; exposure response; cytarabine daunorubicin;
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Clinical Pharmacology"
DOI: 10.1002/jcph.1771
Abstract: We report the population pharmacokinetic (PK) and exposure‐response analyses of a novel subcutaneous formulation of daratumumab (DARA) using data from 3 DARA subcutaneous monotherapy studies (PAVO Part 2, MMY1008, COLUMBA) and 1 combination therapy study… read more here.
Keywords: exposure response; intravenous dara; dara; monotherapy ... See more keywords
Innovations in the Delivery of Exposure and Response Prevention for Obsessive-Compulsive Disorder.
Sign Up to like & getrecommendations! Published in 2021 at "Current topics in behavioral neurosciences"
DOI: 10.1007/7854_2020_202
Abstract: Obsessive-Compulsive Disorder is an important cause of global health-related disability. In the last several decades, exposure and response prevention (EX/RP) has emerged as one of the most evidence-based treatments for adult and pediatric OCD. Recommended… read more here.
Keywords: exposure response; compulsive disorder; response; obsessive compulsive ... See more keywords
Exposure–response analyses of trastuzumab emtansine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane
Sign Up to like & getrecommendations! Published in 2017 at "Cancer Chemotherapy and Pharmacology"
DOI: 10.1007/s00280-017-3440-4
Abstract: PurposeIn the phase III EMILIA study, trastuzumab emtansine (T-DM1) significantly improved progression-free survival (PFS) and overall survival (OS) versus capecitabine plus lapatinib (control) in previously treated human epidermal growth factor receptor 2-positive advanced breast cancer.… read more here.
Keywords: model predicted; exposure response; response; exposure ... See more keywords
A joint model of longitudinal pharmacokinetic and time-to-event data to study exposure–response relationships: a proof-of-concept study with alectinib
Sign Up to like & getrecommendations! Published in 2024 at "Cancer Chemotherapy and Pharmacology"
DOI: 10.1007/s00280-024-04698-w
Abstract: In exposure–response analyses of oral targeted anticancer agents, longitudinal plasma trough concentrations are often aggregated into a single value even though plasma trough concentrations can vary over time due to dose adaptations, for example. The… read more here.
Keywords: time; exposure response; response; trough concentrations ... See more keywords
Population pharmacokinetics and exposure-response analysis of durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer
Sign Up to like & getrecommendations! Published in 2025 at "Cancer Chemotherapy and Pharmacology"
DOI: 10.1007/s00280-024-04743-8
Abstract: Durvalumab in combination with gemcitabine/cisplatin has shown a favorable benefit-risk profile in the TOPAZ-1 study for advanced biliary tract cancers (BTC). This analysis evaluated the population pharmacokinetics (PopPK) of durvalumab, and exposure-response for efficacy and… read more here.
Keywords: treatment; analysis; exposure response; population ... See more keywords
A comprehensive evaluation of exposure–response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Pharmacokinetics and Pharmacodynamics"
DOI: 10.1007/s10928-018-9581-1
Abstract: Guselkumab, a human IgG1 monoclonal antibody that blocks interleukin-23, has been evaluated in one Phase 2 and two Phase 3 trials in patients with moderate-to-severe psoriasis, in which disease severity was assessed using Psoriasis Area… read more here.
Keywords: exposure response; response; guselkumab dose; evaluation ... See more keywords