Results 41 to 50 of about 13,844,580 (194)
CPT: Pharmacometrics & Systems Pharmacology, 2023 This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu +17 more
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Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics
British Journal of Clinical Pharmacology, EarlyView.Abstract This review focuses on the development of radiopharmaceutical imaging agents and radioligand therapeutics for paediatric use. Nuclear medicine plays an important role in the diagnosis and treatment of various childhood conditions, including cancers, infections and brain disorders.
Justin L. Hay +5 more
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Frontiers in Pharmacology, 2022 ST-246 is an oral drug against pathogenic orthopoxvirus infections. An intravenous formulation is required for some critical patients. A ternary complex of ST-246/meglumine/hydroxypropyl-β-cyclodextrin with well-improved solubility was successfully ...
Zhiwei Zhang +8 more
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British Journal of Clinical Pharmacology, EarlyView.Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
Parameters Used for PBPK Model.
, 2013 Parameters Used for PBPK Model.
John Wambaugh (230167) +1 more
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Physiology Based Pharmacokinetic (Pbpk) Model in Paediatric Drug Development
, 2023 Purpose Physiologically based pharmacokinetic (PBPK) modelling, a mathematical modelling approach which uses a pharmacokinetic model to mimic human physiology to predict drug concentration–time profiles, has been used for the discover and development of ...
D.M. Ravichand, G Naveen choudary,
core +1 more source
Molecules, 2019 Tozadenant is one of the selective adenosine A2a receptor antagonists with a potential to be a new Parkinson’s disease (PD) therapeutic drug. In this study, a liquid chromatography-mass spectrometry based bioanalytical method was qualified and ...
Byeong ill Lee +7 more
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Mathematics, 2022 Here we describe a toolkit for presenting physiologically based pharmacokinetic (PBPK) models in a modular graphical view in the BioUML platform.
Elena Kutumova +4 more
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British Journal of Clinical Pharmacology, EarlyView.Abstract Aim Liquid biopsy is minimally invasive (compared with tissue biopsy) and has previously been used to generate systems data regarding drug elimination via hepatic enzymes and transporters. This study extends quantitative assessment of systems parameters in liquid biopsy to pharmacodynamic (PD) and disease markers relevant to cancer development
Zubida M. Al‐Majdoub +3 more
wiley +1 more source
PBPK-based in vivo contextualization of in vitro toxicity data (PICD).
, 2017 INPUT: At the organism level, PBPK models are developed for specific drugs. At the cellular level, in vitro response data of compound-treated primary hepatocytes are analyzed (28).
Lorenzo Fabbri (3712408) +8 more
core +1 more source