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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…
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Keywords:
population pharmacokinetic;
population;
exposure response;
metabolizer status ... See more keywords
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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.…
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Keywords:
cpx 351;
exposure response;
cytarabine daunorubicin;
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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…
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Keywords:
exposure response;
intravenous dara;
dara;
monotherapy ... See more keywords
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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…
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Keywords:
exposure response;
compulsive disorder;
response;
obsessive compulsive ... See more keywords
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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.…
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Keywords:
model predicted;
exposure response;
response;
exposure ... See more keywords
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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…
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Keywords:
exposure response;
response;
guselkumab dose;
evaluation ... See more keywords
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Published in 2018 at "Journal of Pharmacokinetics and Pharmacodynamics"
DOI: 10.1007/s10928-018-9592-y
Abstract: Evolocumab, a novel human monoclonal antibody, inhibits proprotein convertase subtilisin/kexin type 9, a protein that targets low-density lipoprotein-cholesterol (LDL-C) receptors for the treatment of hyperlipidemia. The primary objective of this analysis was to characterize the…
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Keywords:
exposure response;
response;
population pharmacokinetics;
simulation ... See more keywords
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Published in 2018 at "Journal of Pharmacokinetics and Pharmacodynamics"
DOI: 10.1007/s10928-018-9610-0
Abstract: Accurate characterization of exposure–response relationship of clinical endpoints is important in drug development to identify optimal dose regimens. Endpoints with ≥ 10 ordered categories are typically analyzed as continuous. This manuscript aims to show circumstances where…
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Keywords:
mayo scores;
modeling mayo;
response modeling;
exposure response ... See more keywords
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Published in 2021 at "Journal of pharmacokinetics and pharmacodynamics"
DOI: 10.1007/s10928-021-09784-7
Abstract: A central question in drug discovery is how to select drug candidates from a large number of available compounds. This analysis presents a model-based approach for comparing and ranking combinations of radiation and radiosensitizers. The…
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Keywords:
modeling improves;
response modeling;
exposure response;
improves selection ... See more keywords
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Published in 2021 at "Journal of pharmacokinetics and pharmacodynamics"
DOI: 10.1007/s10928-021-09796-3
Abstract: Exposure-response modeling is important to optimize dose and dosing regimens in clinical drug development. While primary clinical trial endpoints often have few categories and thus provide only limited information, sometimes there may be additional, more…
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Keywords:
response modeling;
exposure response;
endpoint;
response ... See more keywords
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Published in 2018 at "Applied Acoustics"
DOI: 10.1016/j.apacoust.2018.04.037
Abstract: Abstract Since the first synthesis curves were reported, a number of social surveys have been conducted to assess community response to noise, and determine a suitable exposure-response relationship for each socio-cultural area within different environments.…
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Keywords:
exposure response;
response;
annoyance;
community ... See more keywords