Results 91 to 100 of about 9,895 (222)

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

A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation

Clinical Pharmacology &Therapeutics, EarlyView.
The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix, Sam Mostafa, Amin Rostami‐Hodjegan, Thomas M. Polasek, Carl M. J. Kirkpatrick   +4 more
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

Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients

Clinical Pharmacology &Therapeutics, EarlyView.
ISB 2001 is a trispecific antibody that binds to two tumor‐associated antigens (TAA), CD38 and BCMA, and crosslinks to CD3 on T cells resulting in T cell‐mediated cytotoxicity of tumor cells expressing these TAAs. ISB 2001 is currently being tested in relapsed and/or refractory multiple myeloma (RRMM) patients in the first‐in‐human (FIH) TRIgnite‐1 ...
Vinu Chandralayam Ayyappa Menon, Tomomi Matsuura, Beata Holkova, Girish S. Gudi, Adam Drake, Maria Pihlgren, Piet H. van der Graaf, Sunitha GN, Andrew Garton, Mario Perro, Cyril Konto, Lida Pacaud   +11 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

Translational physiologically-based pharmacokinetic (PBPK) modeling and simulation to support drug development and pharmacotherapy [PDF]

, 2018
The Physiologically-based Pharmacokinetic (PBPK) approach was successfully used within four projects to meet challenges in drug development and pharmacotherapy.
Moj, Daniel Andreas
core   +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

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

ZeroPM piece 12 PBPK modelling

ZeroPM Pieces, 2022
ZeroPM piece 12 about PBPK modelling. The presentation can be viewed as a film on the ZeroPM youtube channel.
openaire   +2 more sources

Payload‐Based Clinical Pharmacology Review of Approved Antibody–Drug Conjugates: Commonalities and Considerations for Streamlined Development

Clinical Pharmacology &Therapeutics, EarlyView.
Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the potency of a cytotoxic drug. Thirteen ADCs, utilizing seven unique cytotoxic payloads and targeting 11 distinct antigens, are currently approved by the US Food and Drug Administration as of June 2025, representing a rapidly growing and highly promising class of anticancer ...
Sijie Lu, Qingqing Xiao, Lixuan Qian, Siyuan Sun, Zhu Zhou, Michael Z. Liao, Chunze Li   +6 more
wiley   +1 more source