Results 21 to 30 of about 6,010 (176)

Mechanistic Modeling of Intra‐Tumor Spatial Distribution of Antibody‐Drug Conjugates: Insights into Dosing Strategies in Oncology

open access: yesClinical and Translational Science, 2021
Antibody drug conjugates (ADCs) provide targeted delivery of cytotoxic agents directly inside tumor cells. However, many ADCs targeting solid tumors have exhibited limited clinical efficacy, in part, due to insufficient penetration within tumors.
Jared Weddell   +4 more
doaj   +1 more source

Phase II Dose Selection for Alpha Synuclein–Targeting Antibody Cinpanemab (BIIB054) Based on Target Protein Binding Levels in the Brain

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2020
This modeling and simulation analysis was aimed at selecting doses of cinpanemab (BIIB054), a monoclonal antibody targeting aggregated α‐synuclein, for a phase II study in Parkinson’s disease (PD).
Mita Kuchimanchi   +4 more
doaj   +1 more source

Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis

open access: yesClinical and Translational Science, 2021
Elagolix is a novel, oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids.
Sven Stodtmann   +8 more
doaj   +1 more source

Advancing Pharmacometrics and Systems Pharmacology [PDF]

open access: yesClinical Pharmacology & Therapeutics, 2012
Pharmacometrics and systems pharmacology are emerging as principal quantitative sciences within drug development and experimental therapeutics. In recognition of the importance of pharmacometrics and systems pharmacology to the discipline of clinical pharmacology, the American Society for Clinical Pharmacology and Therapeutics (ASCPT), in collaboration
Waldman, Scott A., Terzic, Andre
openaire   +2 more sources

Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets

open access: yesAAPS Open, 2023
Patients who have difficulty swallowing apalutamide tablets may benefit from administration in a food vehicle that is easier to swallow. In a previous single-dose study conducted in healthy male volunteers (n = 12) a larger peak exposure was observed ...
Alex Yu, Oliver Ackaert
doaj   +1 more source

Follow-Up Bias in Tumor Dynamic Modeling: A Comparison of Classical and Neural-ODE Approaches. [PDF]

open access: yesCPT Pharmacometrics Syst Pharmacol
ABSTRACT Tumor dynamic models are vital for evaluating oncology treatments and guiding clinical drug development decisions. However, few studies rigorously assess their predictive capabilities, especially when forecasting tumor trajectories from clinical trials with short or inconsistent follow‐up across treatment arms.
Turner DC   +7 more
europepmc   +2 more sources

Pharmacometrics: Focus on the Patient [PDF]

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2014
Pharmacometrics, whether using simple or complex models, has contributed to rational and efficient drug development,(1-3) with the main focus on early drug development.(4) This article describes why opportunities more directly focused on the patient abound in late stage development, illustrating the concept with three innovative examples which focus on
Dumitrescu, T Pene   +2 more
openaire   +2 more sources

Optimization of trial duration to predict long‐term HbA1c change with therapy: A pharmacometrics simulation‐based evaluation

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2022
Glycated hemoglobin (HbA1c) is the main biomarker of diabetes drug development. However, because of its delayed turnover, trial duration is rarely shorter than 12 weeks, and being able to predict long‐term HbA1c with precision using data from shorter ...
Hanna Kunina   +4 more
doaj   +1 more source

Scaling Approaches for Pediatric Dose Selection: The Fremanezumab (AJOVY®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data from a Phase 1 Study

open access: yesPharmaceutics, 2021
Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and prevents it from binding to the CGRP receptor.
Aksana Jones   +3 more
doaj   +1 more source

The Use of Translational Modelling and Simulation to Develop Immunomodulatory Therapy as an Adjunct to Antibiotic Treatment in the Context of Pneumonia

open access: yesPharmaceutics, 2021
The treatment of respiratory tract infections is threatened by the emergence of bacterial resistance. Immunomodulatory drugs, which enhance airway innate immune defenses, may improve therapeutic outcome.
Robin Michelet   +12 more
doaj   +1 more source

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