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Clinical and Translational Science
Scopus
ISSN 1752-8062 · Wiley · 1,851 articles in the index
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Journal Article
A Framework to Quantify Disparities in Pharmacogenomic Treatment Concordance and Drug Response Outcomes
ABSTRACT Clinical PGx practice guidelines (PGx guidelines) may have limited generalizability for “marginalized” groups. We proposed the five‐step Real‐World Data for Genome‐Guided Prescribing (ReGGRx) framework and, using All of Us research program (AoU) data, examined its ability to estimate…
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Journal Article
Pharmacogenomics of Thiopurine Drugs: A Bench‐To‐Bedside Success Story in Thailand
ABSTRACT Thiopurine drugs are the cornerstone treatment for many diseases such as acute lymphoblastic leukemia (ALL), organ rejection, inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and other autoimmune diseases. However, their clinical use faces…
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Journal Article
Quantitative Prediction of Human Pharmacokinetics for Fc‐Engineered Therapeutic Monoclonal Antibodies With Increased FcRn Binding Mutations After Subcutaneous Injection
ABSTRACT Fc‐engineered antibodies (mAbs) enhancing FcRn binding have rapidly expanded in drug discovery and development. Although an approach exists for predicting the pharmacokinetics of Fc‐engineered mAbs after intravenous injections in humans, no methodology has been established for predicting…
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Journal Article
Effects of Siltuximab Versus Corticosteroids in Preventing COVID−19 Pneumonia Disease Progression: Multicentre, Open‐Label, Randomized Clinical Trial
ABSTRACT In 2020, COVID‐19 caused a global health crisis, prompting research efforts and accelerating drug development. As part of this response, we conducted a phase 2b, multicentre, open‐label, randomized (1:1) clinical trial to compare the effects of siltuximab versus corticosteroids on disease…
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Journal Article
Prognostic Model–Guided Randomization Improves Efficiency in Early‐Phase Trials: Evidence From Surveys and Simulations
ABSTRACT Early‐phase trials often struggle to detect treatment effects due to small sample sizes and substantial patient heterogeneity. While randomization is the standard for balancing treatment arms, many trials fail to account for key prognostic factors, potentially reducing statistical power…
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Journal Article
Concomitant Use of DPP‐4 Inhibitors May Prevent the Development of Oxaliplatin‐Induced Peripheral Neuropathy: A Retrospective Cohort Study
ABSTRACT Oxaliplatin‐induced peripheral neuropathy (OIPN) causes numbness and pain in the limbs, often leading to interruption of chemotherapy and representing a significant clinical problem. Previous basic studies have suggested that the dipeptidyl peptidase‐4 (DPP‐4) inhibitor alogliptin may…
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Journal Article
The Effect of Ecopipam on the Pharmacokinetics of Concomitant Medications
ABSTRACT Ecopipam is a first‐in‐class dopamine D1 receptor antagonist under investigation for the treatment of Tourette syndrome. This open‐label, fixed‐sequence, three‐cohort study evaluated whether ecopipam induces or inhibits cytochrome P450 (CYP) 1A2, CYP2B6, CYP2C19, CYP2D6, CYP3A4, organic…
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Journal Article
The Effect of Uridine Diphosphate‐Glucuronosyltransferase Inhibition on the Pharmacokinetics of Ecopipam and Its Metabolites
ABSTRACT Ecopipam, a selective dopamine D1 receptor antagonist in development for Tourette syndrome, is primarily converted by uridine diphosphate‐glucuronosyltransferase (UGT)1A9 to ecopipam glucuronide, with a minor metabolic pathway by cytochrome P450 3A4 forming EBS‐101‐40853 (also referred to…
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Journal Article
Clinical and Economic Impact of Expanded TPMT Testing to Prevent Thiopurine‐Induced Myelosuppression in Australia: A Budget Impact Analysis
ABSTRACT Testing thiopurine methyltransferase (TPMT) enzyme activity or genotype prior to thiopurine prescribing is recommended to reduce the risk of moderate to severe—and potentially fatal—myelosuppression in poor or intermediate TPMT metabolizers. Despite this, only about one‐third of…
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Journal Article
Open‐Label Study Assessing Relative and Absolute Bioavailability of Oral Camizestrant Formulations and Food Effects in Healthy Postmenopausal Women
ABSTRACT Camizestrant is the next‐generation oral selective estrogen receptor degrader and complete estrogen receptor antagonist in Phase 3 development for hormone receptor‐positive breast cancer. To investigate the impact of manufacturing changes during pivotal Phase 3 studies, this open‐label…
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Journal Article
Dicloxacillin and Flucloxacillin Inhibit Hepatic Uptake Transporters—In Vitro Investigations and Physiologically Based Pharmacokinetic Modeling
ABSTRACT Dicloxacillin and flucloxacillin are β‐lactamase‐resistant penicillin antibiotics that have been in clinical use for over 50 years. While both antibiotics are known to induce cytochrome P450 enzymes, there is limited information available regarding their interactions with drug…
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Journal Article
Enhanced Clearance of HIV‐1 Broadly Neutralizing Antibody VRC07‐523‐LS During Viremia: Influences on Trial Design and Analysis
ABSTRACT Broadly neutralizing antibodies (BNAb) are capable of neutralizing multiple HIV‐1 strains through the targeting of conserved epitopes. This study's objective was to quantify the pharmacokinetic (PK) parameters describing the distribution and elimination of the BNAb VRC07‐523‐LS in people…
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Journal Article
Can Environmental Enrichment Mitigate Cell Apoptosis in the Central Nervous System Under Adverse Health Conditions? A Systematic Review
ABSTRACT To summarize the available evidence in the literature regarding the effects of exposure to an enriched environment (EE) on the modulation of apoptotic markers in central tissue of rodents under unfavorable conditions. Searches were conducted in three databases: PubMed/Medline (70…
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Journal Article
A First‐In‐Human Randomized Controlled Phase 1 Study Assessing the Safety and Tolerability of Topical TCP‐25 Gel in Epidermal Suction Blister Wounds
ABSTRACT Inflammation and infection remain unmet challenges in wounds of various etiologies, delaying healing, impacting quality of life, and increasing healthcare costs. The thrombin‐derived C‐terminal peptide TCP‐25 has demonstrated dual anti‐inflammatory and antibacterial activities in animal…
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Journal Article
Optimal Dosage Justification for Datopotamab Deruxtecan in HR‐Positive/HER2‐Negative Breast Cancer Through Model‐Informed Drug Development Approaches
ABSTRACT Project Optimus has been reforming the dose selection and optimization paradigm in oncology. In this context, model‐informed drug development (MIDD) approaches were utilized to validate the optimal dose selection of 6 mg/kg every 3 weeks (Q3W) for datopotamab deruxtecan (Dato‐DXd) in…
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Journal Article
Clinical Characteristics, Molecular Diagnosis, and Drug Resistance Profiles of Nontuberculous Mycobacteria Infections: A Retrospective Analysis Using PCR Melting Curve Technology
ABSTRACT Nontuberculous mycobacteria (NTM) are emerging global pathogens. This study aimed to analyze the clinical features, species distribution, and drug resistance profiles of NTM infections in a northern Chinese hospital. A retrospective cohort study included 1769 patients with suspected…
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Journal Article
Pacific Blue Derivatives of Paclitaxel as Fluorescent Probes of OATP1B‐Type Transporters
ABSTRACT Paclitaxel (Taxol) is a widely used anticancer agent that undergoes extensive hepatic metabolism and that causes a debilitating, dose‐limiting peripheral neurotoxicity. We previously reported that the uptake of paclitaxel in hepatocytes and dorsal root ganglion neurons, the site of injury…
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Journal Article
Intrinsic Factors Influencing Simvastatin and Simvastatin Acid Pharmacokinetics: Age‐Related Studies in Thai Adults and Cross‐Population Comparisons
ABSTRACT Intrinsic factors such as age and ethnicity influence statin pharmacokinetics (PK) and may increase the risk of muscle‐related adverse events. This study investigated the effect of age on the PK of simvastatin (SV) and its active metabolite, simvastatin acid (SVA), in healthy Thai subjects…
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Journal Article
Six‐Year Trends in Real‐World Data Use for Post‐Marketing Surveillance of New Medical Products in Japan
ABSTRACT The Ministerial Ordinance on Good Post‐Marketing Study Practice for Drugs was amended by the Ministry of Health, Labour and Welfare (MHLW) in 2018 to clearly define post‐marketing database studies (DBS) as a measure of pharmacovigilance activities for approved medical products in Japan…
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Journal Article
Efavirenz and CYP2C9 Genetic Polymorphisms Reduce CYP2C9 Activity in Healthy Participants
ABSTRACT Efavirenz's effects on cytochrome P450 2C9 (CYP2C9) activity have not been formally characterized in vivo. We conducted the first clinical drug–drug interaction (DDI) study to test the effect of chronic efavirenz dosing on CYP2C9 activity, using tolbutamide as a selective probe. Healthy…
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