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Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1157-1158, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3637 Issue No: Vol. 117, No. 5 (2025)
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Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1162-1163, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3648 Issue No: Vol. 117, No. 5 (2025)
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Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1164-1170, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3638 Issue No: Vol. 117, No. 5 (2025)
- MRI Provides New Insights Into the Pharmacologic Mechanism of Bisacodyl: A
Blueprint for Understanding Intestinal Drug Mechanisms-
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Kathleen M. Giacomini
Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1159-1161, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3646 Issue No: Vol. 117, No. 5 (2025)
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Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1149-1154, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3321 Issue No: Vol. 117, No. 5 (2025)
- Methodological Insights on Biomarker‐Based Patient Selection: A Review
of Scientific Advice Procedures at the European Medicines Agency-
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Cynthia Huber; Joerg Zinserling,
Norbert Benda,
Thorsten Vetter,
Marcia Rueckbeil Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1226-1235, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3558 Issue No: Vol. 117, No. 5 (2025)
- A 2024 Update on US FDA Implementation of Partial Area Under the Curve
Into Bioavailability and Bioequivalence Assessments-
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Robert Hopefl; Yuqing Gong,
Elizabeth Bielski,
Venkateswaran C Pillai,
Bryan Newman,
Bin Qin,
Yan Wang,
Miyoung Yoon,
Qiangnan Zhang,
Ethan Stier,
Ramana Uppoor,
Hao Zhu,
Lei Zhang,
Lanyan Fang Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1185-1193, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3561 Issue No: Vol. 117, No. 5 (2025)
- Machine Learning for Prediction of Drug Concentrations: Application and
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Shuqi Huang; Qihan Xu,
Guoping Yang,
Junjie Ding,
Qi Pei Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1236-1247, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3577 Issue No: Vol. 117, No. 5 (2025)
- Mapping the Clinical Development Trajectory of Cell and Gene Therapy
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Magdi Elsallab; Michelle Ouvina,
Andrea Arfe,
Florence T. Bourgeois Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1264-1271, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3512 Issue No: Vol. 117, No. 5 (2025)
- Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of
Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation-
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Authors:
Abdulsalam Aliyu; Neele Dellschaft,
Caroline Hoad,
Hannah Williams,
Emily Gaudoin,
Sarah Sulaiman,
Colin Crooks,
Penny Gowland,
Alexia Aran,
Robert Lange,
Beatrice Bois De Fer,
Maura Corsetti,
Luca Marciani,
Robin Spiller Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1284-1291, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3532 Issue No: Vol. 117, No. 5 (2025)
- Model‐Informed Once‐Daily Dosing Strategy for Bedaquiline and
Delamanid in Children, Adolescents and Adults with Tuberculosis-
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Yu‐Jou Lin; Louvina E. van der Laan,
Mats O. Karlsson,
Anthony J. Garcia‐Prats,
Anneke C. Hesseling,
Elin M. Svensson Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1292-1302, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3536 Issue No: Vol. 117, No. 5 (2025)
- Microdose Cocktail Study Reveals the Activity and Key Influencing Factors
of OATP1B, P‐Gp, BCRP, and CYP3A in End‐Stage Renal Disease Patients-
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Weijie Kong; Yuejuan Pan,
Yujie Wu,
Yiyi Hu,
Zhenbin Jiang,
Xinkui Tian,
Shuhong Bi,
Song Wang,
Feifei Feng,
Yuyan Jin,
Jiayu Li,
Haiyan Li,
Yue Wang,
Hao Liang,
Wen Tang,
Dongyang Liu Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1303-1312, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3546 Issue No: Vol. 117, No. 5 (2025)
- Investigation of Genomic and Transcriptomic Risk Factors of Clopidogrel
Response in African Americans-
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Guang Yang; Cristina Alarcon,
Catherine Chanfreau,
Norman H. Lee,
Paula Friedman,
Edith Nutescu,
Matthew Tuck,
Travis O'Brien,
Li Gong,
Teri E. Klein,
Kyong‐Mi Chang,
Philip S. Tsao,
David O. Meltzer,
Julie A. Lynch,
Million Veteran Program,
Sony Tuteja,
Minoli A. Perera Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1313-1324, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3552 Issue No: Vol. 117, No. 5 (2025)
- Evolving Research and Development Landscape for Rare Diseases: Growing
Concerns Over Orphan Drug Lag in Japan-
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Kazuaki Enya; Itsuki Kageyama,
Yoshiyuki Kobayashi,
Yeongjoo Lim,
Shintaro Sengoku,
Kota Kodama Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1325-1337, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3553 Issue No: Vol. 117, No. 5 (2025)
- Characterization of NAT, GST, and CYP2E1 Genetic Variation in
Sub‐Saharan African Populations: Implications for Treatment of Tuberculosis and Other Diseases-
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Thandeka V.B. Malinga; Houcemeddine Othman,
Maria Paximadis,
Caroline T. Tiemessen,
Michèle Ramsay,
Scott Hazelhurst,
David Twesigomwe Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1338-1357, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3557 Issue No: Vol. 117, No. 5 (2025)
- Effect of Target‐Mediated Disposition on Iptacopan Clinical
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Elise Burmeister Getz; Richard R. Stein,
Martin Fink,
Kenneth Kulmatycki,
Irina Baltcheva,
Wendy Weis,
Bharti Shah,
Eric Lawitz,
Robert Schmouder Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1358-1368, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3559 Issue No: Vol. 117, No. 5 (2025)
- Cytokine Dynamics in Action: A Mechanistic Approach to Assess Interleukin
6 Related Therapeutic Protein‐Drug–Disease Interactions-
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Xian Pan; Katherine L. Gill,
Amita Pansari,
Oliver Hatley,
Liam Curry,
Masoud Jamei,
Iain Gardner Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1369-1380, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3560 Issue No: Vol. 117, No. 5 (2025)
- Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With
Concomitant Rifampicin: A Dose Escalation Study-
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Amedeo De Nicolò; Alice Palermiti,
Henry Mugerwa,
Shamim Nakabuye,
Josephine Namusanje,
Josephine Kobusingye,
Denis Odoch,
Mohammed Lamorde,
Allan Kengo,
Paolo Denti,
Kamunkhwala Gausi,
Gary Maartens,
Helen McIlleron,
Lubbe Wiesner,
Saye Khoo,
Catriona Waitt,
Antonio D'Avolio Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1393-1402, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3572 Issue No: Vol. 117, No. 5 (2025)
- Clinical Evaluation of Drug–Drug Interactions with Obeldesivir, an
Orally Administered Antiviral Agent-
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Chi‐Chi Peng; Rita Humeniuk,
Anuja Raut,
Anna Kwan,
Lily Mak,
Caitlin Stacom,
Deqing Xiao,
Shuguang Chen,
Santosh Davies,
Sharline Madera,
Yiannis Koullias,
Amos Lichtman,
Joe Llewellyn,
Elham Amini,
Helen Winter,
Luzelena Caro Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1403-1412, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3575 Issue No: Vol. 117, No. 5 (2025)
- CB1 Receptor Antagonist Selonabant (ANEB‐001) Blocks Acute THC Effects
in Healthy Volunteers: A Phase II Randomized Controlled Trial-
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Andriy A. Gorbenko; Jules A. A. C. Heuberger,
Maria Juachon,
Erica Klaassen,
Michael Tagen,
Joseph F. Lawler,
Daniel Schneeberger,
Kenneth C. Cundy,
Linda E. Klumpers,
Geert J. Groeneveld Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1427-1436, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3581 Issue No: Vol. 117, No. 5 (2025)
- Pharmacokinetic Modeling and Model‐Based Hypothesis Generation for Dose
Optimization of Clonidine in Neonates With Neonatal Opioid Withdrawal Syndrome-
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Fei Tang; Chee M. Ng,
Jamie Horn,
Henrietta S. Bada,
Markos Leggas Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1254-1263, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3507 Issue No: Vol. 117, No. 5 (2025)
- Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After
Nephrotoxic and Ischemic Injury-
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Sushrut S. Waikar; Robin Mogg,
Amanda F. Baker,
Gyorgy Frendl,
Michael Topper,
Scott Adler,
Stefan Sultana,
Runqi Zhao,
Nicholas M. P. King,
Steven P. Piccoli,
John‐Michael Sauer,
Steve Hoffmann,
Irene Nunes,
Frank D. Sistare Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1272-1283, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3531 Issue No: Vol. 117, No. 5 (2025)
- Association of Influenza Vaccination During Pregnancy with Health Outcomes
in Mothers and Children: A Population‐Based Cohort Study-
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Authors:
Hyesung Lee; Dongwon Yoon,
Ju Hwan Kim,
Yunha Noh,
Eun‐Jeong Joo,
Jung Yeol Han,
Young June Choe,
Ju‐Young Shin Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1381-1392, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3565 Issue No: Vol. 117, No. 5 (2025)
- Navigating the Challenges of Cyclosporine as an Alternative to Rifampicin
as an OATP1B Index Inhibitor-
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Manthena V. S. Varma; Manoli Vourvahis Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1175-1178, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3564 Issue No: Vol. 117, No. 5 (2025)
- Japan's Conditional/Time‐Limited Early Approval System in Regenerative
Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets-
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Hayase Hakariya; Akihiko Ozaki,
Yudai Kaneda,
Tetsuya Tanimoto Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1171-1174, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3562 Issue No: Vol. 117, No. 5 (2025)
- A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines
into Clinical Practice-
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Authors: Teresa T. Ho; D. Max Smith, Christina L. Aquilante, Emily J. Cicali, Nihal El Rouby, Daniel L. Hertz, Iman Imanirad, Jai N. Patel, Stuart A. Scott, Sandra M. Swain, Sony Tuteja, J. Kevin Hicks, on behalf of the Pharmacogenomics Global Research Network Publication Committee Abstract: Clinical Pharmacology &Therapeutics, Volume 117, Issue 5, Page 1194-1208, May 2025. PubDate: 2025-04-12T02:44:31-07:00 DOI: 10.1002/cpt.3567 Issue No: Vol. 117, No. 5 (2025)
- Oncology Dose Optimization: Tailored Approaches to Different Molecular
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Jiawen Zhu; Amy Schroeder,
Sabine Frank,
Christophe Boetsch,
Candice Jamois,
Nastya Kassir,
Koorosh Korfi,
Elizabeth Punnoose,
Anjali Vaze,
Peter Trask,
Pritti Gosai,
Jane Fridlyand,
Chunze Li Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-18T03:34:42-07:00 DOI: 10.1002/cpt.3658
- ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000
Genomes Project and Native American Populations-
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Mariana M. Scudeler; Caíque Manóchio,
Bruno Miwa,
Guilherme Belfort‐Almeida,
Lucas Faria‐Costa,
Cesar Sanchez,
Carlos Padilla,
Omar Caceres,
Eduardo Tarazona‐Santos,
Heinner Guio,
Timothy D. O'Connor,
Fernanda Rodrigues‐Soares Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-17T08:51:45-07:00 DOI: 10.1002/cpt.3681
- Innovations and Best Practices for Therapeutic Development in Pediatric
Rare Diseases: A Model‐Informed Drug Development Perspective-
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Rajesh Krishna; Satyendra Suryawanshi,
Juliane Rascher,
Sonja Hartmann,
Bernard Sebastien,
Jeffrey S. Barrett Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-16T04:30:05-07:00 DOI: 10.1002/cpt.3683
- Supplementing Single‐Arm Trials with External Control Arms—Evaluation
of German Real‐World Data-
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Martin Russek; Jonas Peltner,
Britta Haenisch Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-16T04:08:30-07:00 DOI: 10.1002/cpt.3684
- Prenatal and Early Childhood Exposure to Antibiotics or Gastric Acid
Inhibitors and Increased Risk of Epilepsy: A Nationwide Population‐Based Study-
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Unnur Gudnadottir; Ronny Wickström,
Anna Gunnerbeck,
Stefanie Prast‐Nielsen,
Nele Brusselaers Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-15T01:37:26-07:00 DOI: 10.1002/cpt.3679
- Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications
Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024 -
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Jie Zhang; Li Yang Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-14T06:56:38-07:00 DOI: 10.1002/cpt.3676
- Emergence of Small Nucleic Acids as Drugs in Precision Medicine
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Xing Cheng; Yan Wang,
Tingting Zhang,
Yuening Cao,
Hongbin Cheng,
Yong Du,
Xian Ge,
Bo Ren,
Jun Lu,
Liuying Li Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-14T02:10:09-07:00 DOI: 10.1002/cpt.3678
- Exposure–Response Relationships in Patients with Non‐Small‐Cell Lung
Cancer and Other Solid Tumors Treated with Patritumab Deruxtecan (HER3‐DXd)-
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Li Li; Mark Lee,
Rujuta Joshi,
Yuan Xu,
Ramon Garcia,
Kyle Baron,
Eric Anderson,
Tim Waterhouse,
David Sternberg,
Pomy Shrestha,
Pavan Vaddady,
Malaz Abutarif,
Tushar Garimella Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-11T04:11:07-07:00 DOI: 10.1002/cpt.3674
- Participants in the FDA's Biomarker Qualification Program
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Mahnum Shahzad; Ariel D. Stern Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-09T04:02:17-07:00 DOI: 10.1002/cpt.3661
- ASCPT 125th Anniversary: A Society Leadership Perspective
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Sandra A. G. Visser Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-08T12:03:47-07:00 DOI: 10.1002/cpt.3653
- Empowering Early‐Career Scientists: Opportunities Through ASCPT
Programs, Networks, and Communities-
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Sheena Sharma; Jacqueline Gerhart,
Iris K. Minichmayr,
Natasha Strydom,
Patricia D. Maglalang,
Michael Liao,
Tao Long,
Sonya Tang Girdwood,
Akinyemi Oni‐Orisan,
Keroles Nakhla,
Dan Li Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-08T10:49:38-07:00 DOI: 10.1002/cpt.3664
- Establishing a Validation Framework of Treatment Discontinuation in Claims
Data Using Natural Language Processing and Electronic Health Records-
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Chun‐Ting Yang; Kerry Ngan,
Dae Hyun Kim,
Jie Yang,
Jun Liu,
Kueiyu Joshua Lin Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-08T05:25:58-07:00 DOI: 10.1002/cpt.3650
- Reply to “Translational Modeling as a Tool to Evaluate the Effectiveness
of Nalmefene in a Community Setting: A Critical Perspective”-
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Shilpa Chakravartula,
John Mann,
Seyed Hamed Meshkin,
Jeffry Florian Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-08T03:30:48-07:00 DOI: 10.1002/cpt.3669
- Translational Modeling as a Tool to Evaluate the Effectiveness of
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Phil Skolnick Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-08T03:24:04-07:00 DOI: 10.1002/cpt.3668
- Optimizing Maternal and Fetal Antibody Exposure and Dosing Regimens During
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Rui Zhong,
Jacqueline B. Tiley,
Yanguang Cao Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-04T12:57:00-07:00 DOI: 10.1002/cpt.3656
- Reply to “Chat GPT and the Challenges to Detect Potential Drug–Drug
Interactions Related to QT Prolongation”-
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Markus Zeitlinger,
Anselm Jorda,
Michelle Hana,
Karla‐Nikita Singeorzan,
Nikolaus Riesenhuber,
Gunar Stemer,
Christian Schoergenhofer Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-02T01:10:52-07:00 DOI: 10.1002/cpt.3662
- Use of Real‐World Claims Data to Assess the Prevalence of Concomitant
Medications to Inform Drug–Drug Interaction Risk in Target Patient Populations-
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Alice S. Tang; Logan Brooks,
Denise M. Boudreau,
Pascal Chanu,
Amita Joshi,
Bianca Vora,
Rui Zhu Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-01T11:39:47-07:00 DOI: 10.1002/cpt.3652
- Identification and Clinical Evaluation of Potential Biomarkers for Breast
Cancer Resistance Protein (BCRP/ABCG2)-
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Jia Yang,
Claire M. Brett,
Kelsey Trumbach,
Xujia Zhou,
Renmeng Liu,
Xiaomin Liang,
Yurong Lai,
Runlan Huo,
Yongjun Xue,
Hong Shen,
Lei Zhang,
Xinning Yang,
Qi Liu,
Shiew‐Mei Huang,
Kathleen M. Giacomini Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-01T11:39:18-07:00 DOI: 10.1002/cpt.3657
- Chat GPT and the Challenges to Detect Potential Drug–Drug Interactions
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Fabrizio De Ponti Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-04-01T06:12:57-07:00 DOI: 10.1002/cpt.3660
- First‐in‐Human Single and Multiple Ascending Dose Studies of
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Dietmar Weitz,
Johann Gassenhuber,
Markus Rehberg,
Markus Kohlmann,
Fabienne Schumacher,
Amel Lahmar,
Andreas Kovar,
Laurent Perrin,
Frank‐Dietrich Wagner,
Maria Wiekowski,
Mai Anh Nguyen Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-30T10:16:09-07:00 DOI: 10.1002/cpt.3655
- Frequency and Nature of Generic “Design Around” of Brand‐Name
Patents in the United States-
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- Hepatic Impairment and the Differential Effects on Drug Clearance
Mechanisms: Analysis of Pharmacokinetic Changes in Disease State-
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- Impact of Model‐Informed Drug Development on Drug Development Cycle
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Gianluca Nucci,
Cynthia J Musante,
Brian Corrigan Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-26T06:19:08-07:00 DOI: 10.1002/cpt.3636
- Impact of Age and Factor Xa Inhibitor Concentrations on Bleeding Risk in
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Li‐Ting Ho,
Ching‐Hua Kuo,
Yu‐Fong Peng,
Chih‐Fen Huang,
Sung‐Chun Tang,
Jiann‐Shing Jeng Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-25T12:40:38-07:00 DOI: 10.1002/cpt.3654
- Confirmatory Evidence Used in Non‐Oncologic Rare Disease New Molecular
Entity Marketing Applications Approved by FDA, 2020–2023-
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Jennifer R. Pippins,
Salvatore Pepe,
Mary Doi,
Audrey Thomas,
Brandon Bagheri,
Cynthia Welsh,
Rajanikanth Madabushi,
Kerry Jo Lee Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-20T07:23:58-07:00 DOI: 10.1002/cpt.3630
- ICH M12 Drug Interaction Studies: Summary of the Efforts to Achieve Global
Convergence-
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Sheila Annie Peters,
Vikram Sinha,
Helen Heymann,
Luiza Novaes Borges,
Heidi J. Einolf,
Shujun Fu,
Motohiro Hoshino,
Li Li,
Elin Lindhagen,
So Miyoshi,
Katsuhiko Mizuno,
Venkatesh Pilla Reddy,
Matthias S. Roost,
Ryota Shigemi,
Xiaolu Tao,
Meng‐Syuan Yang,
Sylvia Zhao,
Carolien Versantvoort,
Akihiro Ishiguro,
Rajanikanth Madabushi Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-19T10:48:39-07:00 DOI: 10.1002/cpt.3625
- Drug‐Event Pairs as Indicators for the Detection of Adverse Drug
Reactions during Hospitalization in Routinely Collected Electronic Data Sources-
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Wolfgang Fehrmann,
Clara Weglage,
Tobias Dreischulte,
Ulrich Jaehde Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-18T04:43:17-07:00 DOI: 10.1002/cpt.3635
- Changes in S‐Citalopram Plasma Concentrations Across Pregnancy and
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Michael J. Avram,
Alfred L. George Jr; Amy Yang,
Jody D. Ciolino,
Hyunyoung Jeong,
Raman Venkataramanan,
Steve N. Caritis,
Maged M. Costantine,
Katherine L. Wisner Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-18T04:39:28-07:00 DOI: 10.1002/cpt.3642
- Impact of Cancer Cachexia Progression on OATP1B1 Transport Activity:
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Yosuke Suzuki,
Jun Negami,
Yoshio Sueshige,
Ayako Oda,
Ken Shiraiwa,
Takashi Inagaki,
Kazuo Nishikawa,
Ryosuke Tatsuta,
Satoshi Otsu,
Masao Ogata,
Keiko Ohno,
Hiroki Itoh Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-17T12:04:41-07:00 DOI: 10.1002/cpt.3649
- Quantitative Contributions of Hepatic and Renal Organic Cation
Transporters to the Clinical Pharmacokinetic Cimetidine–Metformin Interaction-
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Aarzoo Thakur,
Erin C. Boone,
Andrea Gaedigk,
Mary F. Paine,
Bhagwat Prasad Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-17T10:39:22-07:00 DOI: 10.1002/cpt.3639
- Optimizing Brentuximab Vedotin Dosing in Pediatric Patients with Advanced
Hodgkin Lymphoma: A Population Pharmacokinetic and Exposure‐Response Analysis-
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Lia Gore,
Xiang Bai,
Neeraj Gupta Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-17T05:09:00-07:00 DOI: 10.1002/cpt.3629
- Erratum to “Lenacapavir: Playing the Long Game in the New Era of
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Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-16T11:28:05-07:00 DOI: 10.1002/cpt.3647
- Night‐Time Chronotherapy with Methylprednisolone Prevents an Acute
Rejection in Pediatric Patients with Liver Transplantation: A Randomized Clinical Trial-
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Shinya Otomo,
Keiko Ogaki,
Taiichi Wakiya,
Noriki Okada,
Yuta Hirata,
Yasuharu Onishi,
Yasunaru Sakuma,
Yukiyo Wada,
Akio Fujimura,
Koichi Mizuta Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-16T11:24:26-07:00 DOI: 10.1002/cpt.3640
- Regulatory Approval of CAR‐T Cell and BsAb Products for Lymphoid
Neoplasms in the US, EU, and Japan-
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Kayo Shinohara,
Sumimasa Nagai Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-14T07:07:54-07:00 DOI: 10.1002/cpt.3645
- Model‐Informed Drug Development Applications and Opportunities in
mRNA‐LNP Therapeutics-
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Monica E. Shapiro,
Nessy Tania,
Cody Herron,
Cynthia J. Musante,
Jim H. Hughes Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-14T01:24:46-07:00 DOI: 10.1002/cpt.3641
- Challenges and Possible Strategies to Address Them in Rare Disease Drug
Development: A Statistical Perspective-
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Jie Chen; Lei Nie,
Shiowjen Lee,
Haitao Chu,
Haijun Tian,
Yan Wang,
Weili He,
Thomas Jemielita,
Susan Gruber,
Yang Song,
Roy Tamura,
Lu Tian,
Yihua Zhao,
Yong Chen,
Mark van der Laan,
Hana Lee Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-13T06:18:12-07:00 DOI: 10.1002/cpt.3631
- Establishment of a Biomarker‐Directed Clinical Endpoint Model for
Early‐Stage Parkinson's Disease Patients-
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Churni Gupta; Chaejin Kim,
Serge Guzy,
Tomoki Yoneyama,
Hamidreza Gharahi,
Vijay Kumar Siripuram,
Sergio Iadevaia,
Dipak Barua,
Yaming Hang,
Tatiana Iakovleva,
Christina Boucher,
Majid Vakilynejad,
Stephan Schmidt,
Valvanera Vozmediano Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-12T10:49:12-07:00 DOI: 10.1002/cpt.3593
- Sodium‐Glucose Cotransporter‐2 Inhibitors and Diabetic‐Ketoacidosis
in T2DM Patients: An Updated Meta‐Analysis and a Mendelian Randomization Analysis-
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Yufei Wang; Yuhan Qin,
Jing Zhang,
Anhu Wu,
Xiaohan Qin,
Le Du,
Huabing Zhang,
Xiaoxiao Guo,
Shuyang Zhang Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-11T11:00:52-07:00 DOI: 10.1002/cpt.3615
- A Benchmark, Expand, and Calibration (BenchExCal) Trial Emulation Approach
for Using Real‐World Evidence to Support Indication Expansions: Design and Process for a Planned Empirical Evaluation-
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Shirley V. Wang; Massimiliano Russo,
Robert J. Glynn,
Marie C. Bradley,
Jiwei He,
John Concato,
Sebastian Schneeweiss Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-11T08:00:48-07:00 DOI: 10.1002/cpt.3621
- Current Status and Future Directions in the Development of Digital
Therapeutic Interventions for Neurodevelopmental Disorders-
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Hyun‐ju Lee; Yoo Joo Jeong,
Jun‐Su Kim,
Seung‐Jae Kim,
Unhui Jo,
Su Jin Jun,
Jongmin Lim,
Jin‐Yeop Park,
Myungji Lee,
Donggi Kim,
Jeong‐Heon Song,
Hyang‐Sook Hoe Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-11T07:06:36-07:00 DOI: 10.1002/cpt.3633
- Integrated Evidence Planning for Enhancing Patient Care: Harnessing the
Power of Real‐World Evidence-
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- Regulatory Perspective Based on Survey of Relationship Between
Biopharmaceutical Characteristics and Food Effects on Systemic Pharmacokinetics-
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Yasuhisa Ideno,
Ryota Takaoka,
Akihiro Ishiguro Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-10T12:54:40-07:00 DOI: 10.1002/cpt.3622
- Evolving Recommendations for Patient Populations Among Oncology Medicines:
A Quantitative and Qualitative Analysis-
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Milou A. Hogervorst; Rick A. Vreman,
Theresa A. Oduol,
Aukje K. Mantel‐Teeuwisse,
Wim G. Goettsch,
Aaron S. Kesselheim Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-10T01:26:01-07:00 DOI: 10.1002/cpt.3628
- Use of Sodium‐Glucose Transport Protein 2 Inhibitors and the Incidence
of Urolithiasis: A Multi‐Database and Cross‐Country Study in Patients With Type 2 Diabetes Mellitus-
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Chao‐Hsiang Chang,
Yi‐Huei Chang,
Po‐Jen Hsiao,
Chi‐Shun Lien,
Laing‐You Wu,
Ming‐Ju Wu,
Jeng‐Jer Shieh,
Peir‐Haur Hung,
Hsin‐Hua Chen,
Chi‐Jung Chung Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-10T01:14:35-07:00 DOI: 10.1002/cpt.3626
- Characterizing Treatment Effect Heterogeneity Using Real‐World Data
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Haedi Thelen; Sean Hennessy Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-06T04:49:32-08:00 DOI: 10.1002/cpt.3627
- SLCO1B1 Functional Variants, Bilirubin, Statin‐Induced Myotoxicity, and
Recent Sub‐Saharan African Ancestry: A Precision Medicine Health Equity Study-
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Tanushree Haldar; Mark Kvale,
Jia Yang,
Michael P. Douglas,
Willow Coyote‐Maetas,
Linda Kachuri,
John S. Witte,
Carlos Iribarren,
Marisa W. Medina,
Ronald M. Krauss,
Sook Wah Yee,
Akinyemi Oni‐Orisan Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-06T04:39:36-08:00 DOI: 10.1002/cpt.3624
- A National Study Among Diverse US Populations of Exposure to Prescription
Medications with Evidence‐Based Pharmacogenomic Information-
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Loren Saulsberry; Jacob C. Jameson,
Robert D. Gibbons,
M. Eileen Dolan,
Olufunmilayo I. Olopade,
Peter H. O’Donnell Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-03T10:13:26-08:00 DOI: 10.1002/cpt.3617
- Identification of Genetic Variants Associated with Pravastatin and
Pitavastatin Pharmacokinetics-
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Anssi J. H. Mykkänen; E. Katriina Tarkiainen,
Suvi Taskinen,
Mikko Neuvonen,
Maria Paile‐Hyvärinen,
Tuomas O. Lilius,
Tuija Tapaninen,
Janne T. Backman,
Aleksi Tornio,
Mikko Niemi Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-03-03T05:13:49-08:00 DOI: 10.1002/cpt.3623
- Acute Effects and Pharmacokinetics of LSD after Paroxetine or Placebo
Pre‐Administration in a Randomized, Double‐Blind, Cross‐Over Phase I Trial-
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Anna M. Becker; Mélusine Humbert‐Droz,
Lorenz Mueller,
Alen Jelušić,
Avram Tolev,
Isabelle Straumann,
Isidora Avedisian,
Livio Erne,
Jan Thomann,
Dino Luethi,
Edna Grünblatt,
Henriette Meyer zu Schwabedissen,
Matthias E. Liechti Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-28T10:19:53-08:00 DOI: 10.1002/cpt.3618
- QTc Interval Changes in Preeclampsia vs. Normal Pregnancy: A Systematic
Review and Meta‐Analysis-
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Omar A. Aboshady; Jess Z. Raffa,
Sara K. Quinney,
James E. Tisdale,
Brian R. Overholser Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-27T12:11:11-08:00 DOI: 10.1002/cpt.3605
- Assessing Correlation between Surrogate Endpoints and Overall Survival for
Oncology Clinical Trials-
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Jiaju Wu,
Yike Tang,
Jonathan Luu,
Chunsheng He,
Shu‐Pang Huang,
Liangang Liu,
Hsin‐Ju Hsieh Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-27T02:19:38-08:00 DOI: 10.1002/cpt.3613
- The Unrealized Potential of Advanced Modeling Methods to Inform Early
Strategic Planning for Payer Reimbursement-
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Ananth Kadambi; Nicholas C. Anderson,
Sandra A.G. Visser,
Matthew L. Zierhut Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-25T12:29:05-08:00 DOI: 10.1002/cpt.3620
- A Joint Pharmacometric Model of Iohexol and Creatinine Administered
through a Meat Meal to Assess GFR and Renal OCT2/MATE Activity-
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Charalambos Dokos,
Jana Boland,
Uwe Fuhr,
Max Taubert Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-25T05:07:24-08:00 DOI: 10.1002/cpt.3612
- Dose Determinations at Drug Approval Reviews: FDA‐Approved Drugs in
Past 5 Years-
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Sachiko Mita; Shunsuke Ono Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-25T04:29:39-08:00 DOI: 10.1002/cpt.3611
- Opportunities and Challenges of Hepatic Impairment Physiologically Based
Pharmacokinetic Modeling in Drug Development—An IQ Perspective-
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Hisham Qosa; Islam R. Younis,
Vaishali Sahasrabudhe,
Ashish Sharma,
Jin Yan,
Gerald Galluppi,
Maria M. Posada,
Jitendra Shrawan Kanodia Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-23T08:28:46-08:00 DOI: 10.1002/cpt.3601
- Impact of Regulatory Post‐Market Safety Advisories on Prescribing
Practices: An Interrupted Time Series Analysis-
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Seonji Kim; Subin Kim,
Chungsoo Kim,
Junhyuk Chang,
Rae Woong Park,
Kyung Won Kim,
Seng Chan You Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-22T12:00:00-08:00 DOI: 10.1002/cpt.3614
- A Phenotyping Tool for Seven Cytochrome P450 Enzymes and Two Transporters:
Application to Examine the Effects of Clopidogrel and Gemfibrozil-
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Laura Aurinsalo; Outi Lapatto‐Reiniluoto,
Mika Kurkela,
Mikko Neuvonen,
Johanna I. Kiiski,
Mikko Niemi,
Aleksi Tornio,
Janne T. Backman Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-21T06:45:58-08:00 DOI: 10.1002/cpt.3610
- Implementing Pharmacogenomics Clinical Decision Support: A Comprehensive
Tutorial on how to Integrate the Epic Genomics Module-
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Bradley T. Hall; Eda Eken,
Larisa H. Cavallari,
Julio D. Duarte,
Kristin W. Wiisanen,
Emily J. Cicali,
Khoa A. Nguyen Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-17T06:23:52-08:00 DOI: 10.1002/cpt.3599
- A Novel Two‐Part Mixture Model for the Incidence and Time Course of
Cytokine Release Syndrome After Elranatamab Dosing in Multiple Myeloma Patients-
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Donald Irby; Jennifer Hibma,
Mohamed Elmeliegy,
Diane Wang,
Erik Vandendries,
Kamrine Poels,
Blerta Shtylla,
Jason H. Williams Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-16T09:05:12-08:00 DOI: 10.1002/cpt.3533
- A Comprehensive CYP2D6 Drug–Drug–Gene Interaction Network for
Application in Precision Dosing and Drug Development-
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Simeon Rüdesheim; Helena Leonie Hanae Loer,
Denise Feick,
Fatima Zahra Marok,
Laura Maria Fuhr,
Dominik Selzer,
Donato Teutonico,
Annika R. P. Schneider,
Juri Solodenko,
Sebastian Frechen,
Maaike van der Lee,
Dirk Jan A. R. Moes,
Jesse J. Swen,
Matthias Schwab,
Thorsten Lehr Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-14T09:48:32-08:00 DOI: 10.1002/cpt.3604
- Insights into Clinical Trials for Drugs Targeting MASLD: Progress,
Challenges, and Future Directions-
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Yu Wu; Pu Dong,
Qifang Wu,
Ya Zhang,
Gang Xu,
Chenwei Pan,
Haibin Tong Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-14T09:14:28-08:00 DOI: 10.1002/cpt.3606
- Dose‐Optimization of a Novel Co‐Formulated Triple Combination
Antimalarial Therapy: Artemether‐Lumefantrine‐Amodiaquine-
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Arjen M. Dondorp Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-12T11:35:21-08:00 DOI: 10.1002/cpt.3582
- Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of
Neonatal Opioid Withdrawal Syndrome'-
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Walter K. Kraft
Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-11T12:00:00-08:00 DOI: 10.1002/cpt.3600
- Optimal Dosing Regimen for Epcoritamab, a Subcutaneous Bispecific
Antibody, in Relapsed or Refractory Large B‐Cell Lymphoma-
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Tommy Li; Leonid Gibiansky,
Apurvasena Parikh,
Matthew Putnins,
Christopher W. Chiu,
Mariana Sacchi,
Huaibao Feng,
Tahamtan Ahmadi,
Manish Gupta,
Steven Xu Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-11T09:51:13-08:00 DOI: 10.1002/cpt.3588
- Model‐Informed Selection of the Recommended Phase 2 Dosage for
Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement-
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Irina Kareva; Ping Hu,
Vadryn Pierre,
Thomas Kitzing,
Anja Victor,
Emilia Richter,
Wei Gao,
Karthik Venkatakrishnan,
Anup Zutshi Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-08T12:00:00-08:00 DOI: 10.1002/cpt.3590
- IQ Survey Results on Current Industry Practices: Part 2—Quantitative
Evaluations of Immunogenicity Assessment-
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Susan Richards; Insa Winzenborg,
Doreen Luedtke,
Tao Niu,
Lora Hamuro,
Karey Kowalski,
Jocelyn H. Leu,
Jianning Yang,
Vaishnavi Ganti,
Indranil Bhattacharya,
Ivelina Gueorguieva,
Nael Mostafa,
Christine Grimaldi,
Benjamin Wu Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-07T09:39:21-08:00 DOI: 10.1002/cpt.3573
- Model‐Based Prediction of Clinically Relevant Thrombocytopenia after
Allogeneic Hematopoietic Stem Cell Transplantation-
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Katharina M. Götz; Amin T. Turki,
Katharina Och,
Dominik Selzer,
Christian Brossette,
Norbert Graf,
Jochen Rauch,
Stefan Theobald,
Yvonne Braun,
Kerstin Rohm,
Gabriele Weiler,
Simeon Rüdesheim,
Matthias Schwab,
Lisa Eisenberg,
Nico Pfeifer,
Stephan Kiefer,
Ulf Schwarz,
Claudia Riede,
Sigrun Smola,
Dietrich W. Beelen,
Dominic Kaddu‐Mulindwa,
Jürgen Rissland,
Jörg Bittenbring,
Thorsten Lehr Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-06T05:25:00-08:00 DOI: 10.1002/cpt.3580
- The Role and Mechanisms of Aurora Kinases in Kidney Diseases
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Meiying Chang; Qiuyi Li,
Zhenwei Shi,
Shougang Zhuang Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-02-05T06:42:21-08:00 DOI: 10.1002/cpt.3584
- IQ Survey Results on Current Industry Practices—Part 1:
Immunogenicity Risk Assessment-
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Authors:
Christine Grimaldi; Susan Richards,
Daniel Baltrukonis,
Shelley Sims Belouski,
Kelly Coble,
Sanjay L. Dholakiya,
Joanna Grudzinska‐Goebel,
Gerry Kolaitis,
Jocelyn H. Leu,
Linlin Luo,
Stephen Lowe,
Tao Niu,
Henrik Toft‐Hansen,
Jianning Yang,
Benjamin Wu Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-01-28T09:49:23-08:00 DOI: 10.1002/cpt.3568
- Esketamine Nasal Spray in Major Depressive Disorder: A Meta‐Analysis of
Randomized Controlled Trials-
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Authors:
Zhibin Wang; Lili Jiang,
Wenzhuang Ma,
Xingyue Li,
Qiushi Gao,
Siyu Lian,
Weiwei Yu Abstract: Clinical Pharmacology &Therapeutics, EarlyView. PubDate: 2025-01-10T01:09:30-08:00 DOI: 10.1002/cpt.3555
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