Results 61 to 70 of about 13,844,580 (194)

A Comprehensive Framework for Physiologically‐Based Pharmacokinetic Modeling in Matlab

CPT: Pharmacometrics & Systems Pharmacology, 2019
Physiologically‐based pharmacokinetic (PBPK) models are useful tools to predict clinical scenarios for special populations for whom there are high hurdles to conduct clinical trials such as children or the elderly.
Felix Stader, Melissa A. Penny, Marco Siccardi, Catia Marzolini   +3 more
doaj   +1 more source

Repurposing Drugs for Malaria through a Human Dose Prediction: A Case Study with Berzosertib

Clinical Pharmacology &Therapeutics, EarlyView.
Repurposing drugs whose clinical safety has been established offers a valuable approach to reduce the cost and time associated with the development of new drugs for malaria. Here, we investigate the potential to repurpose the anticancer kinase inhibitor berzosertib for the treatment of malaria, by assessing whether a predicted efficacious human dose ...
Devasha Redhi, Mwila Mulubwa, Mmakwena M. Mmonwa, Mathew Njoroge, Liezl Krugmann, Kelly Chibale   +5 more
wiley   +1 more source

AI‐Enabled Precision Dosing in Pediatrics: Enhancing Model‐Informed Decision Making

Clinical Pharmacology &Therapeutics, EarlyView.
Ensuring safe and effective pharmacotherapy for children remains a central challenge in clinical pharmacology, yet rapid advances in AI have not translated into clinical practice. This Perspective highlights how AI‐enabled approaches can enhance model‐informed decision making for precision dosing.
Kei Irie, Tomoyuki Mizuno
wiley   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Characterization of Lysosomal Hydrolases and Transporters and Their Age‐Dependent Variability: Relevance to Drug Metabolism and Transport of Small Molecule and Biologic Drugs

Clinical Pharmacology &Therapeutics, EarlyView.
Lysosomes play a key role in the accumulation, catabolism, and transport of endogenous and exogenous metabolites and proteins and are involved in drug metabolism and prodrug activation. However, the protein abundance and interindividual variability of lysosomal drug‐metabolizing enzymes and transporters (DMETs) remain underexplored.
Darshak Gadara, Dilip Kumar Singh, Sandhya Subash, Guihua Yue, Deepak Ahire, Chris Bohl, Maciej Czerwinski, Stephanie Helmstetter, Scott Heyward, Robert S. Jones, Cyrus Khojasteh, Ryota Kikuchi, Priyanka Kulkarni, Bin Ma, Bernard Murray, Chris Seib, Bill Smith, David M. Stresser, Mitchell E. Taub, Ting Wang, Bhagwat Prasad   +20 more
wiley   +1 more source

Drug Interaction PBPK Modeling: Review of the Literature Exposes the Need for Increased Verification of Model Inputs and Outputs as Part of Credibility Assessment

Clinical and Translational Science
In vitro data are routinely used to support both static and physiologically based pharmacokinetic (PBPK) model‐based drug–drug interaction (DDI) predictions.
David Rodrigues, Christopher R. Gibson, Nina Isoherranen   +2 more
doaj   +1 more source

Virtual Twin Approach Using Physiologically Based Pharmacokinetic Modeling to Support Precision Dosing of Valproic Acid in Geriatric Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Personalized dosing is particularly important for drugs with narrow therapeutic indices in geriatric patients, who exhibit substantial physiological variability and limited pharmacokinetic (PK) evidence to guide individualized dose selection. Valproic acid (VPA) is an effective treatment option for bipolar disorder in older adults, yet dosing largely ...
Yoo Jin Jang, Dong‐Gyu Heo, Eunjin Hong   +2 more
wiley   +1 more source

Physiologically Based Pharmacokinetic (PBPK) model for biodistribution of radiolabeled peptides in patients with neuroendocrine tumours [PDF]

, 2016
Objective(s): The objectives of this work was to assess the benefits of the application of Physiologically Based Pharmacokinetic (PBPK) models in patients with different neuroendocrine tumours (NET) who were treatedwith Lu-177 DOTATATE.
Knoll, Peter, Peter Knoll, Viktor Popov, Mirzaei, Siroos, Radovan Gospavic, Siroos Mirzaei, Popov, Viktor, Gospavić, Radovan   +7 more
core   +1 more source

Quantitative Systems Toxicology Model Predicts Obeticholic Acid‐Associated Liver Injury in Metabolic Dysfunction‐Associated Steatotic Liver Disease

Clinical Pharmacology &Therapeutics, EarlyView.
Obeticholic acid (OCA), a synthetic analog of chenodeoxycholic acid, was approved in 2016 for the treatment of primary biliary cholangitis. Early clinical trials revealed elevated liver biomarkers in healthy subjects receiving supratherapeutic OCA doses (100–250 mg).
Abigail K. Mayo, James J. Beaudoin, Jeffrey L. Woodhead, Paul B. Watkins, Kim L. R. Brouwer   +4 more
wiley   +1 more source

Applied Concepts in PBPK Modeling: How to Extend an Open Systems Pharmacology Model to the Special Population of Pregnant Women

CPT: Pharmacometrics & Systems Pharmacology, 2018
This tutorial presents the workflow of adapting an adult physiologically based pharmacokinetic (PBPK) model to the pregnant populations using the Open Systems Pharmacology (OSP) software suite (www.open-systems-pharmacology.org).
André Dallmann, Juri Solodenko, Ibrahim Ince, Thomas Eissing   +3 more
doaj   +1 more source