The Journal of Clinical Pharmacology最新文献

{"title":"How to Replace the TQT Study—The Use of Concentration-QTc Modeling to Exclude a Small Effect of a Novel Drug on QT Interval: Historical Perspective and Implementation","authors":"Borje Darpo MD, PhD,&nbsp;Georg Ferber PhD,&nbsp;Seth C Hopkins PhD,&nbsp;Karine Litherland PhD,&nbsp;Nenad Sarapa MD,&nbsp;Hongqi Xue PhD,&nbsp;Robert Kleiman MD","doi":"10.1002/jcph.70237","DOIUrl":"10.1002/jcph.70237","url":null,"abstract":"<p>The initial ICH E14 guidance described the thorough QT/QTc (TQT) study with the purpose of evaluating whether a new drug has effects on the QTc interval. Following its adoption, concentration-QTc (C-QTc) modeling was applied to data from TQT studies, and results were comparable with those based on a “by time point” analysis. In 2014, the IQ-CSRC study demonstrated that a small study in healthy subjects using C-QTc as the primary analysis could detect mild drug-induced QTc prolongation. The study led to the revision of the E14 guidance in 2015, allowing the use of C-QTc modeling to exclude a QTc effect at the threshold of concern, 10 ms. The 2015 revision was the starting point for the use of C-QTc modeling applied to data from first-in-human (FIH) studies with the intent to waive requests for a designated TQT study. The 2022 revision (S7B/E14 Q&amp;A) brought non-clinical studies into the decision process for a “definitive” QT evaluation. In this manuscript, the emergence of C-QTc analysis applied to FIH studies with the intent to waive the TQT study is described, and a survey of FDA labels and reviews of approved drugs since 2015 is shared. The uptake has been modest, with only 30% of approved drugs for which a TQT study would be expected using this approach, while a TQT study has been conducted in ∼70% of development programs. It can be expected that the 2022 S7B/E14 revision will increase the number of programs for which a TQT study can be replaced.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148392175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genome Sequencing Enhances Precision and Clinical Utility of Pharmacogenetic Data Compared to Arrays","authors":"Ibrahim Numanagić PhD,&nbsp;Morgan Similuk PhD, ScM,&nbsp;Tristan M. Sissung PhD, MS,&nbsp;Ananth Hari PhD,&nbsp;Michael K. B. Ford MS,&nbsp;Magdalena A. Walkiewicz PhD,&nbsp;Jia Yan PhD, MS,&nbsp;Rajarshi Ghosh PhD, FACMG,&nbsp;Justin Lack PhD,&nbsp;Wenjia Cao MS,&nbsp;Ryan N. Baugher PhD, MS,&nbsp;Todd B. Young MS,&nbsp;Teri Manolio MD, PhD,&nbsp;Leslie G. Biesecker MD,&nbsp;Stephen M. Hewitt MD, PhD,&nbsp;Suleyman Cenk Sahinalp PhD,&nbsp;Steven M. Holland MD,&nbsp;William D. Figg PharmD, MBA","doi":"10.1002/jcph.70235","DOIUrl":"10.1002/jcph.70235","url":null,"abstract":"<p>While pharmacogenetic testing has traditionally relied on array-based genotyping platforms, these methods are limited by incomplete variant coverage and inability to detect novel alleles. We hypothesize that the performance of genome sequencing (GS) is superior to that of an array-based genotyping method for gene–drug pairs that are clinically implemented at the NIH Clinical Center. DNA was collected from a cohort of 293 patients from a single-center prospective cohort study at the National Institutes of Health, Bethesda, MD. Post hoc analysis was conducted in probands with genetically inferred ancestry: European, African, African American, and Asian. The primary endpoint was to determine concordance between GS, exome sequencing (ES), and a commercial genotyping array while assessing accuracy of non-concordant alleles using orthogonal sequencing. In a cohort of 293 individuals genotyped with a commonly used array, GS (n = 120) and/or ES (n = 185) was conducted. GS demonstrated superior accuracy, resolving unknown or ambiguous array-based allele calls in 5% of cases, ultimately achieving 99% baseline accuracy. Moreover, we confirmed discordances between array-based calls and GS in favor of GS through validation by orthogonal sequencing methods such as long-read sequencing. We highlight clinically significant inaccuracies that include critical variants missed by arrays and ES. From a cost perspective, GS proved comparable or superior to array-based methods, with significantly greater clinical applicability and flexibility. Our findings underscore the feasibility and superiority of integrating GS-based pharmacogenetics testing into clinical settings, demonstrating robust analytical performance, improved patient management potential, and a pathway toward broader, lifetime utility of genomic data.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148392203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FDA Gene Therapy Approvals (1998–2025): Current Status, Regulatory Evolution, and Future Directions","authors":"Charles Oo PharmD, PhD, FCP,&nbsp;Xiaofa Qin MD, PhD,&nbsp;Sherwin KB Sy PhD","doi":"10.1002/jcph.70226","DOIUrl":"10.1002/jcph.70226","url":null,"abstract":"<p>FDA approvals of gene therapies began slowly and were concentrated within a few early modalities, but recent years have seen a marked acceleration across RNA-based agents, viral and non-viral in vivo platforms, and ex vivo genetically modified cell therapies. This expansion reflects the maturation of gene therapy into a diverse therapeutic class while revealing scientific, regulatory, and economic challenges that traditional development paradigms cannot fully accommodate. In response, FDA has introduced platform-aligned, risk-based initiatives—including the plausible mechanism framework, CMC flexibility initiative, and advanced manufacturing technologies program—to support individualized, mechanistically targeted, and potentially curative products. Persistent issues such as high upfront costs, manufacturing complexity, and payer constraints underscore the need for sustainable development and access models. Mechanistic and model-informed drug development, increasingly supported by AI/ML-enabled analytics, is becoming central to dose selection, safety evaluation, and durability prediction. These scientific, regulatory, and clinical-pharmacology perspectives define the evolving landscape of FDA gene therapy approvals and outline future directions needed to ensure durable benefit, equitable access, and long-term safety as genetic medicines expand into broader patient populations.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148383027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Pharmacokinetics and Safety of Imlunestrant in Participants with Hepatic Impairment","authors":"Amita Datta-Mannan PhD,&nbsp;Stephanie White BS,&nbsp;Elaine Shanks PhD,&nbsp;Eunice Yuen PhD,&nbsp;Stephen David Hall PhD,&nbsp;Vivian Rodriguez Cruz PhD,&nbsp;Xuejing Aimee Wang PhD","doi":"10.1002/jcph.70181","DOIUrl":"https://doi.org/10.1002/jcph.70181","url":null,"abstract":"<p>The estrogen receptor (ER) is the key therapeutic target for ER-positive (ER+) breast cancer. Novel ER degraders may overcome resistance to available endocrine therapy while providing consistent oral bioavailability. Imlunestrant is a novel, orally bioavailable selective estrogen receptor degrader (SERD) designed to deliver continuous ER target inhibition. A phase 1, open-label, 3-site study was conducted to characterize the pharmacokinetic (PK) profile of imlunestrant in individuals with varying degrees of hepatic impairment based on Child-Pugh and National Cancer Institute classifications. In this study, participants received a single oral dose of imlunestrant at either 200 or 400 mg in the fasted state, and the pharmacokinetics and safety were assessed in individuals with normal hepatic function and those with mild, moderate, or severe hepatic impairment. Based on Child-Pugh classification, there were no significant differences in the exposure profiles of imlunestrant in participants with mild hepatic impairment in comparison to participants with normal hepatic function. In participants with moderate and severe hepatic impairment, there were significant increases in imlunestrant AUC (but not C_max) observed when compared with normal hepatic function (by 120% and 191% for AUC(0-t_last) and 122% and 206% for AUC(0-∞), respectively). Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity. Nausea and headache were the only TEAEs reported by more than one participant. Treatment-related adverse events were reported by two participants, one each from the moderate and severe hepatic impairment groups. This data will inform the recommendations for dosing patients with hepatic impairment under treatment with imlunestrant.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcph.70181","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Insights into Genetic Polymorphisms Influencing the Therapeutic Efficacy and Toxicity of Rivaroxaban","authors":"Mohammad Salem Hareedy MD,&nbsp;Hayan W. Mubaideen MBChB,&nbsp;Dana O. Al Tarawneh MBChB,&nbsp;Saif A. Abu Ghaida MBChB,&nbsp;Samer F. Zayed MBChB,&nbsp;Sameeh Al-Sarayreh PhD,&nbsp;Abulmaaty M. Elsayed MD,&nbsp;Reem Kamel Pharm D,&nbsp;Yousef M. Al-Saraireh PhD,&nbsp;Sulaiman Mohammed Alnasser PhD","doi":"10.1002/jcph.70236","DOIUrl":"https://doi.org/10.1002/jcph.70236","url":null,"abstract":"<p>Thromboembolic diseases, including venous thromboembolism and atrial fibrillation–related stroke, represent a prevalent health concern and a risk for mortality and health care costs. Rivaroxaban is a direct oral factor Xa inhibitor that is used as an anticoagulant to prevent thromboembolism; although it had a predictable pharmacokinetic profile, it had great inter-individual variability, where some experienced inadequate response and recurrent thrombosis, and others were subjected to bleeding risks. Genetic polymorphisms that could impact the pharmacokinetics and/or pharmacodynamics of rivaroxaban should be involved in its dose adjustment.</p><p>The present work highlighted the current pharmacogenomics evidences influencing rivaroxaban therapy with an analysis of data from previous reports. Using reliable pharmacogenomic profiles can reduce the adverse effects of rivaroxaban and improve patient outcomes in the future.</p><p><i>CYP3A4</i> and <i>CYP3A5</i> polymorphisms greatly impacted the pharmacokinetics of rivaroxaban; <i>CYP2J2</i> polymorphisms were not greatly associated with the clinical outcome. Genetic polymorphisms in membrane transporters like <i>ABCB1</i> and <i>ABCG2</i> could modulate the distribution and absorption of rivaroxaban, leading to inter-individual variation in response. Furthermore, novel genetic polymorphisms in <i>SUSD3</i> and <i>APOB</i> were associated with bleeding risk during rivaroxaban therapy. A preliminary effect of polymorphisms in <i>CYP2C19</i>, <i>PRF1</i>, and <i>PRKAG2</i> on rivaroxaban outcome still needs validation. Both pharmacogenomic analysis (<i>CYP3A4/5, ABCB1, and ABCG2</i>) and drug interactions data could guide dose adjustments of rivaroxaban and significantly decrease the major bleeding risks clinically.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mind the Gap: Unraveling the Pharmacokinetic Variability of Δ9-Tetrahydrocannabinol (THC)","authors":"Shuang Lu MCom,&nbsp;Xin Liu MSc,&nbsp;Linda Truong PhD,&nbsp;Zheng Liu PhD,&nbsp;Fei Guo PhD,&nbsp;Jennifer Martin PhD,&nbsp;Xiao Zhu PhD","doi":"10.1002/jcph.70233","DOIUrl":"https://doi.org/10.1002/jcph.70233","url":null,"abstract":"<p>The global rise in the legalization and medical use of cannabis has underscored the need to understand the pharmacology of its major active compound, Δ9-tetrahydrocannabinol (THC). THC displays complex pharmacokinetic behaviors and marked inter-individual variability, which contribute to inconsistent therapeutic outcomes. Population pharmacokinetic (popPK) modeling has emerged as a key approach to characterizing this variability and guiding individualized dosing strategies. This study systematically reviewed existing popPK models for THC to identify major determinants of pharmacokinetic variability and support future research in medicinal cannabis. A comprehensive search of PubMed, Embase, Web of Science, and Scopus identified 12 popPK models from 11 studies. While both THC and cannabidiol (CBD) were initially screened, the modeling literature was found to be significantly imbalanced; consequently, this review focuses on the 9 identified THC models, with CBD data analyzed in the Supplementary Material. All reviewed THC models employed two- or three-compartment structures, with variability most pronounced in the absorption phase. Between-subject variability in clearance (17%-50%) and volume of distribution (10%-57%) was moderate, whereas bioavailability exhibited wide variability ranging from 22% to 91%. This absorption-related variability was strongly influenced by administration route, usage status, and formulation type. The establishment of a standardized popPK model repository for THC provides a valuable reference for future model development, offering insights into the pharmacokinetic determinants of cannabinoid exposure and supporting model-informed precision dosing in clinical cannabinoid therapy.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Physiologically Based Pharmacokinetic Modeling to Predict the Pharmacokinetics of Sacubitril/Valsartan in the Elderly with Renal or Hepatic Impairment Population","authors":"Jiaqi Shao BSc,&nbsp;Ying Jin PhD,&nbsp;Yingying Yang MSc,&nbsp;Qiulin Xiang MSc,&nbsp;Guoxing Li MSc,&nbsp;Luyuan Shi BSc,&nbsp;Zhihua Duan BSc,&nbsp;Xian Yu PhD","doi":"10.1002/jcph.70180","DOIUrl":"https://doi.org/10.1002/jcph.70180","url":null,"abstract":"<p>This study developed and validated a whole-body physiologically based pharmacokinetic (PBPK) model for sacubitril/valsartan and its active metabolite LBQ657. The model, which incorporates key transporter-mediated clearance pathways, demonstrated robust predictive performance upon validation with clinical data from healthy, renally impaired, and hepatically impaired populations. Simulations using this validated model provided quantitative predictions of steady-state exposure in elderly populations with organ impairment under label-recommended dosing. The results mechanistically confirmed the selective increase in drug exposure driven by organ dysfunction: renal impairment disproportionately elevated LBQ657 exposure, whereas hepatic impairment predominantly increased valsartan exposure. A critical finding was the nuanced interaction between aging and organ impairment, where advanced age selectively exacerbated the exposure of the drug component cleared by the relatively intact organ. This work highlights the potential challenge of balancing exposure for both components when adjusting the dose of this fixed-dose combination in patients with organ dysfunction. The established PBPK model serves as a valuable quantitative tool for informing personalized dosing strategies and supporting clinical decision-making for vulnerable elderly patients with renal or hepatic impairment.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Decoupling CAR-T Expansion, Conversion, and Decay Timing: Physiologically Aligned Semi-Mechanistic Modeling With Smooth Gating and a Cauchy Likelihood Residual Model","authors":"Yiming Cheng PhD,&nbsp;Yan Li PhD","doi":"10.1002/jcph.70232","DOIUrl":"https://doi.org/10.1002/jcph.70232","url":null,"abstract":"<p>Chimeric antigen receptor (CAR) T-cell therapies exhibit complex cellular kinetics with high variability, frequent observations below the limit of quantification (BLQ), and influential outliers. These features can destabilize parameter estimation under Gaussian assumptions, motivating robust likelihood-based approaches. While Student's t residuals with M3 censoring improve robustness, the lack of a closed-form cumulative distribution function (CDF) complicates implementation across platforms like Monolix. We evaluated the Cauchy distribution as an implementation-friendly, heavy-tailed alternative providing closed-form probability density and CDF expressions. In pharmacokinetic simulations with terminal-phase outliers, Cauchy residuals preserved stable parameter recovery comparable to Student's t while Normal residuals exhibited significant bias. In a real-data integrated CAR-T application using full Bayesian inference, Cauchy and Student's t likelihoods yielded highly concordant posterior inference and subject-level predictions. Furthermore, we extended the semi-mechanistic CAR-T framework by replacing piecewise switching with smooth, S-shaped rate functions and process-specific transition times. Full Bayesian summaries supported asynchronous transitions, revealing earlier memory conversion relative to expansion and delayed decay-related transitions. These results support Cauchy likelihoods for robust cross-platform implementation and demonstrate that smooth, decoupled transition modeling enhances the physiological plausibility of CAR-T kinetics.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Human Disposition, Metabolism, and Excretion of Sevasemten (EDG-5506), a Selective Modulator of Fast Myosin in Healthy Volunteers","authors":"Molly Madden BA,&nbsp;Marc Evanchik MS,&nbsp;Jonathan Lane PhD,&nbsp;Joanne Donovan MDPhD,&nbsp;Alan J. Russell PhD,&nbsp;Jeffrey A. Silverman PhD","doi":"10.1002/jcph.70234","DOIUrl":"https://doi.org/10.1002/jcph.70234","url":null,"abstract":"<p>Sevasemten (EDG-5506) is a novel, orally bioavailable, investigational small molecule designed to selectively modulate type II fast skeletal myosin with the goal of protecting dystrophic muscle from contraction-induced injury. Sevasemten is in clinical development for the treatment of Becker and Duchenne muscular dystrophy. In the current Phase 1 study (NCT05730842), eight participants were dosed with a 20 mg single oral suspension dose of sevasemten containing approximately 500 µCi [¹⁴C] sevasemten. Blood and urine samples were collected to evaluate the pharmacokinetics (PK), oral absorption, metabolism, and excretion (AME) of sevasemten and its metabolites. A second cohort of seven participants received a single 20 mg oral dose of sevasemten, followed 2 h later by a single dose of [¹⁴C] sevasemten administered as a single intravenous (IV) bolus with approximately 1 µCi [¹⁴C] sevasemten to determine absolute bioavailability. Sevasemten was excreted primarily in urine (52.1%) subsequent to CYP3A-mediated metabolism, and 8.89% was eliminated in the feces, for a total of 61.0% recovered over 840 h post-dose. Most of the recoverable radioactivity was excreted by 576 h (24 days). However, sevasemten total radioactivity in plasma and whole blood was characterized by a very slow elimination phase of 16.1–20.6 days; total recovery of radioactivity was not achieved. Sevasemten was well tolerated, with no serious adverse events or adverse events leading to study discontinuation. Sevasemten has favorable PK properties for once daily administration and continues to be investigated for the treatment of Becker and Duchenne muscular dystrophies.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcph.70234","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Journal of Clinical Pharmacology: 65 Years of History","authors":"David J. Greenblatt MD, FCP","doi":"10.1002/jcph.70227","DOIUrl":"https://doi.org/10.1002/jcph.70227","url":null,"abstract":"<p>The <i>Journal of Clinical Pharmacology</i> (JCP), published continuously since its founding in 1961, is the principal biomedical publication of the American College of Clinical Pharmacology (ACCP), and is one of the first scientific journals devoted to the discipline of clinical pharmacology. In its 65 years, more than 8000 scientific papers have appeared in the pages of JCP, leading to literature citations exceeding 66,000 in number. Eight distinguished and visionary scientists—beginning with the late McKeen Cattell—have served as Editors-in-Chief over the lifetime (so far) of the Journal, and have guided the growth and maturation of JCP. Other names linked with the early history of JCP and ACCP include Harry Gold, Duncan E. Hutcheon, Nathaniel T. Kwit, Benjamin Calesnick, and Arthur D. Herrick. The ACCP annually presents the McKeen Cattell Award—in honor of the first Editor—to the author of the top scientific paper during the proceeding year. The ACCP looks forward to the continuing development and broadening visibility of JCP as a biomedical publication devoted to excellence in both biomedical research and professional education in the essential field of clinical pharmacology.</p>","PeriodicalId":22751,"journal":{"name":"The Journal of Clinical Pharmacology","volume":"66 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148373015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}