Results 81 to 90 of about 8,529 (239)

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

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

PBPK models in risk assessment—A focus on chloroprene

Chemico-Biological Interactions, 2007
Mathematical models are increasingly being used to simulate events in the exposure-response continuum, and to support quantitative predictions of risks to human health. Physiologically based pharmacokinetic (PBPK) models address that portion of the continuum from an external chemical exposure to an internal dose at a target site.
openaire   +3 more sources

Application of Virtual Twin PBPK Models in Individuals with Obesity via CYP3A4 Phenotyping Using Endogenous Biomarker Data

Clinical Pharmacology &Therapeutics, EarlyView.
Plasma 4β‐hydroxycholesterol (4β‐OHC) normalized for the levels of its parent cholesterol (4β‐OHC/C) is an endogenous biomarker for hepatic CYP3A4. This study evaluated CYP3A4 activity longitudinally in individuals while their obesity status was changing. 4β‐OHC/C was measured pre‐surgery (n = 54) and 2 years after Roux‐en‐Y gastric bypass (n = 30) and
Nihan Izat, Haribhau Kangne, Rasmus Jansson‐Löfmark, Jens K. Hertel, Amin Rostami‐Hodjegan, Ida Robertsen, Aleksandra Galetin   +6 more
wiley   +1 more source

Physiologically-based pharmacokinetic/pharmacodynamic modeling of meropenem in critically ill patients

Scientific Reports
This study aimed to develop a physiologically based pharmacokinetic/pharmacodynamic model (PBPK/PD) of meropenem for critically ill patients. A PBPK model of meropenem in healthy adults was established using PK-Sim software and subsequently extrapolated ...
Yujie Yang, Yirong Wang, Wei Zeng, Jinhua Zhou, Min Xu, Ying Lan, Lvye Liu, Jian Shen, Chuan Zhang, Qin He   +9 more
doaj   +1 more source

PBPK Modeling of Lamotrigine and Efavirenz during Pregnancy: Implications for Personalized Dosing and Drug-Drug Interaction Management

Pharmaceutics
This study aimed to model the pharmacokinetics of lamotrigine (LTG) and efavirenz (EFV) in pregnant women using physiologically based pharmacokinetic (PBPK) and pregnancy-specific PBPK (p-PBPK) models.
Bárbara Costa, Maria João Gouveia, Nuno Vale   +2 more
doaj   +1 more source

Developing integrated PBPK/PD coupled mechanistic pathway model (miRNA-BDNF): An approach towards system toxicology [PDF]

, 2017
Integration of a dynamic signal transduction pathway into the tissue dosimetry model is a major advancement in the area of computational toxicology. This paper illustrates the ways to incorporate the use of existing system biological model in the field ...
M Schuhmacher, V Kumar, Marta Schuhmacher, Vikas Kumar, RP Sharma, Raju Prasad Sharma   +5 more
core   +1 more source

Beyond Tradition: An Integrated Toxicological, Ecological, and Public Health Perspective on Aristolochic Acids

Journal of Applied Toxicology, EarlyView.
ABSTRACT Aristolochia species have long been used in traditional medicine for their presumed anti‐inflammatory, analgesic and antimicrobial properties. However, extensive toxicological and epidemiological evidence now demonstrates that these plants contain aristolochic acids (AAs) I and II, highly potent nephrotoxic, genotoxic, and carcinogenic ...
Victor Ventura de Souza, Lara Rodrigues De Andrade, Tatiana da Silva Souza   +2 more
wiley   +1 more source

Expanded Physiologically‐Based Pharmacokinetic Model of Rifampicin for Predicting Interactions With Drugs and an Endogenous Biomarker via Complex Mechanisms Including Organic Anion Transporting Polypeptide 1B Induction

CPT: Pharmacometrics & Systems Pharmacology, 2019
As rifampicin can cause the induction and inhibition of multiple metabolizing enzymes and transporters, it has been challenging to accurately predict the complex drug–drug interactions (DDIs).
Ryuta Asaumi, Karsten Menzel, Wooin Lee, Ken‐ichi Nunoya, Haruo Imawaka, Hiroyuki Kusuhara, Yuichi Sugiyama   +6 more
doaj   +1 more source

Codeine and Metabolite Concentrations in the Breastfed Neonate

Pediatric Anesthesia, EarlyView.
ABSTRACT Analgesic effect from codeine is from its metabolite, morphine. Morphine is formed by the O‐demethylation of codeine and that enzyme is controlled by the cytochrome P450 2D6. More than 60 alleles in the CYP2D6 gene have been identified. This spectrum of polymorphism can be categorized into four groups: poor (PM), intermediate (IM), normal (NM),
Brian J. Anderson, Jacqueline A. Hannam
wiley   +1 more source