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Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 489-490, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3377
Issue No: Vol. 116, No. 3 (2024)
- Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of
Maslow's Hammer-
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Authors:
Mark J. Ratain
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 508-510, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3264
Issue No: Vol. 116, No. 3 (2024)
- ASCPT News
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Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 499-503, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3372
Issue No: Vol. 116, No. 3 (2024)
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Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 497-498, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3376
Issue No: Vol. 116, No. 3 (2024)
- Getting the Dosage Right: A Vital Role for Clinical Pharmacology in the
Era of Precision Medicine-
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Authors:
Iris K. Minichmayr; Mohamad Shebley,
Piet H. van der Graaf,
Karthik Venkatakrishnan
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 491-496, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3375
Issue No: Vol. 116, No. 3 (2024)
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Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 479-485, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.2946
Issue No: Vol. 116, No. 3 (2024)
- “Getting the Dose Right”—Revisiting the Topic With Focus
on Biologic Agents-
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Authors:
Diane R. Mould; Richard N. Upton
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 613-618, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3285
Issue No: Vol. 116, No. 3 (2024)
- Dose Optimization Informed by PBPK Modeling: State‐of‐the Art
and Future-
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Authors:
Karen Rowland Yeo; Eva Gil Berglund,
Yuan Chen
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 563-576, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3289
Issue No: Vol. 116, No. 3 (2024)
- Oral Drug Dosing After Gastric Bypass and Diet‐Induced Weight Loss:
Simpler Than We Think' Lessons Learned From the COCKTAIL Study-
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Authors:
Kine Eide Kvitne; Jøran Hjelmesæth,
Markus Hovd,
Rune Sandbu,
Line Kristin Johnson,
Shalini Andersson,
Cecilia Karlsson,
Hege Christensen,
Rasmus Jansson‐Löfmark,
Anders Åsberg,
Ida Robertsen
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 647-652, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3307
Issue No: Vol. 116, No. 3 (2024)
- Phenotypic Models of Drug–Drug‐Gene Interactions Mediated by
Cytochrome Drug‐Metabolizing Enzymes-
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Authors:
Roberto Viviani; Judith Berres,
Julia C. Stingl
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 592-601, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3188
Issue No: Vol. 116, No. 3 (2024)
- Beyond Population‐Level Targets for Drug Concentrations: Precision
Dosing Needs Individual‐Level Targets that Include Superior Biomarkers
of Drug Responses-
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Authors:
Thomas M. Polasek; Richard W. Peck
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 602-612, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3197
Issue No: Vol. 116, No. 3 (2024)
- Dose Optimization in Oncology Drug Development: An International
Consortium for Innovation and Quality in Pharmaceutical Development White
Paper-
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Authors:
Divya Samineni; Karthik Venkatakrishnan,
Ahmed A. Othman,
Yazdi K. Pithavala,
Srinivasu Poondru,
Chirag Patel,
Pavan Vaddady,
Wendy Ankrom,
Saroja Ramanujan,
Nageshwar Budha,
Michael Wu,
Nahor Haddish‐Berhane,
Holger Fritsch,
Azher Hussain,
Jitendra Kanodia,
Meng Li,
Mengyao Li,
Murad Melhem,
Apurvasena Parikh,
Vijay V. Upreti,
Neeraj Gupta
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 531-545, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3298
Issue No: Vol. 116, No. 3 (2024)
- Beyond MABEL: An Integrative Approach to First in Human Dose Selection of
Immunomodulators by the Health and Environmental Sciences Institute (HESI)
Immuno‐Safety Technical Committee (ITC)-
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Authors:
Mineo Matsumoto; Joseph Ryan Polli,
Suresh K. Swaminathan,
Kaushik Datta,
Cris Kampershroer,
Marie C. Fortin,
Smita Salian‐Mehta,
Rutwij Dave,
Zheng Yang,
Payal Arora,
Masanori Hiura,
Mizuho Suzuki,
Frank R. Brennan,
Jean Sathish
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 546-562, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3316
Issue No: Vol. 116, No. 3 (2024)
- Dosing and Exposure of Vancomycin With Continuous Infusion: A
Retrospective Study-
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Authors:
Judith Y. M. N. Derijks‐Engwegen; Nynke G.L. Jager
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 665-669, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3221
Issue No: Vol. 116, No. 3 (2024)
- Rationale, Development, and Validation of HdxSim, a Clinical Decision
Support Tool for Model‐Informed Precision Dosing of Hydroxyurea for
Children with Sickle Cell Anemia-
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Authors:
Alexandra Power‐Hays; Min Dong,
Nieko Punt,
Tomoyuki Mizuno,
Luke R. Smart,
Alexander A. Vinks,
Russell E. Ware
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 670-677, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3119
Issue No: Vol. 116, No. 3 (2024)
- Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in
Pediatric Recipients of Heart or Liver Transplants: A Regulatory
Perspective-
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Authors:
Amer Al‐Khouja; Nadia Chaudhri,
Ergun Velidedeoglu,
Ozlem Belen,
Youwei Bi,
Suresh Doddapaneni,
Jianmeng Chen
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 807-813, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3288
Issue No: Vol. 116, No. 3 (2024)
- Pharmacokinetics, Pharmacodynamics, and Safety of Edoxaban in Pediatric
Subjects: A Phase I Single‐Dose Study-
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Authors:
Peng Zou; Hamim Zahir,
Anil Duggal,
Grishma Pandya,
James Jin,
Tarek A. Leil
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 736-746, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3196
Issue No: Vol. 116, No. 3 (2024)
- Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome
with Percutaneous Coronary Intervention-
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Authors:
Ming‐Lung Tsai; Yuan Lin,
Dong‐Yi Chen,
Ming‐Shyan Lin,
Chao‐Yung Wang,
I‐Chang Hsieh,
Ning‐I Yang,
Ming‐Jui Hung,
Tien‐Hsing Chen
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 747-756, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3209
Issue No: Vol. 116, No. 3 (2024)
- Nonlinear Mixed‐Effects Model of Z‐Endoxifen Concentrations in
Tamoxifen‐Treated Patients from the CEPAM Cohort-
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Authors:
Anna M. Mc Laughlin; Thomas Helland,
Fenja Klima,
Stijn L.W. Koolen,
Ron H.N. van Schaik,
Ron H.J. Mathijssen,
Patrick Neven,
Jesse J. Swen,
Henk‐Jan Guchelaar,
Florence Dalenc,
Melanie White‐Koning,
Robin Michelet,
Gerd Mikus,
Werner Schroth,
Thomas Mürdter,
Hiltrud Brauch,
Matthias Schwab,
Håvard Søiland,
Gunnar Mellgren,
Fabienne Thomas,
Charlotte Kloft,
Daniel L. Hertz,
the CYP2D6 Endoxifen Percentage Activity Model (CEPAM) Consortium,
Bram C. Agema,
Anabel Sanchez‐Spitman,
Thais Almeida,
Jeanine Nardin,
José Claudio Casali‐da‐Rocha,
Rosa Esther Moo‐Puc,
Jorge Aarón Rangel‐Mendez,
Gwendolyn McMillin,
Ewa E. Hennig,
Elżbieta Brewczyńska,
Marina Venzon Antunes,
Vincent Haufroid,
Linda Thorén,
Lisa Madlensky,
John Pierce,
Yusuke Nakaumra,
Michiaki Kubo,
Hitoshi Zembutsu,
João Paulo Bianchi Ximenez,
Vera Lucia Lanchote,
James M. Rae,
Daniel F Hayes,
Vered Stearns,
Todd C Skaar,
Zeruesenay Desta,
Stuart A Scott,
Robert J Desnick,
In Hae Park,
Hye In Woo,
Soo‐Youn Lee,
Ana Fernandez‐Santander,
Alicia Romero‐Lorca,
Apolonia Novillo Villajos,
María Gaibar Alonso,
Harriet Johansson,
Bernardo Bonanni,
Andrea DeCensi,
Howard Gurney,
Rosemary Balleine,
William J. Irvin,
Howard L. McLeod,
Matthew P. Goetz,
Joel M. Reid,
Vera J. Suman,
Nutthada Areepium,
Wanaporn Charoenchokthavee,
Diana Eccles,
William Tapper,
Balram Chowbay,
Chiea Chuen Khor,
Elaine Lim Hsuen,
Arafat Tfayli,
Nathalie K. Zgheib,
Cécile Arellano
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 690-702, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3238
Issue No: Vol. 116, No. 3 (2024)
- Predicting the Long‐Term Effects of Therapeutic Neutralization of
Oncostatin M on Human Hematopoiesis-
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Authors:
Anders Thorsted; Chiara Zecchin,
Alienor Berges,
Mats O. Karlsson,
Lena E. Friberg
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 703-715, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3246
Issue No: Vol. 116, No. 3 (2024)
- Assessment of Dosing Strategies for Pediatric Drug Products
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Authors:
Zachary L. Taylor; Francis G. Green,
Nayeem Hossain,
Gilbert J. Burckart,
Michael Pacanowski,
Robert N. Schuck
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 716-723, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3250
Issue No: Vol. 116, No. 3 (2024)
- Model‐Informed Assessment of Probability of Phase 3 Success for
Ritlecitinib in Patients with Moderate‐to‐Severe Ulcerative Colitis-
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Authors:
Jessica Wojciechowski; Arnab Mukherjee,
Christopher Banfield,
Timothy Nicholas
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 724-735, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3251
Issue No: Vol. 116, No. 3 (2024)
- Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery,
Clinical Dose, and Regimen Selection-
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Authors:
Allison M. Claas; Meelim Lee,
Pai‐Hsi Huang,
Charles G. Knutson,
Domenico Bullara,
Birgit Schoeberl,
Suzanne Gaudet
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 757-769, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3267
Issue No: Vol. 116, No. 3 (2024)
- Evaluation of Patient‐Centric Sample Collection Technologies for
Pharmacokinetic Assessment of Large and Small Molecules-
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Authors:
Sandhya Mandlekar; Dhruvitkumar S. Sutaria,
Xiaoyun Yang,
Ryan Johnson,
Yixuan Zou,
Brian Dean,
Liuxi Chen,
Rucha Sane,
Kathi Williams,
Alison Cardenas,
Mary Simon,
Saloumeh Fischer
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 782-794, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3272
Issue No: Vol. 116, No. 3 (2024)
- Transforming the Discovery of Targeted Protein Degraders: The
Translational Power of Predictive PK/PD Modeling-
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Authors:
Robin Thomas Ulrich Haid; Andreas Reichel
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 770-781, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3273
Issue No: Vol. 116, No. 3 (2024)
- Leveraging QSP Models for MIPD: A Case Study for Warfarin/INR
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Authors:
Undine Falkenhagen; Larisa H. Cavallari,
Julio D. Duarte,
Charlotte Kloft,
Stephan Schmidt,
Wilhelm Huisinga
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 795-806, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3274
Issue No: Vol. 116, No. 3 (2024)
- Dealing With Variable Drug Exposure Due to Variable Hepatic Metabolism:
A Proof‐of‐Concept Application of Liquid Biopsy in Renal Impairment-
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Authors:
Amin Rostami‐Hodjegan; Zubida M. Al‐Majdoub,
Yannick von Grabowiecki,
Ka Lai Yee,
Sudhakar Sahoo,
Wolfgang Breitwieser,
Aleksandra Galetin,
Christopher Gibson,
Brahim Achour
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 814-823, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3291
Issue No: Vol. 116, No. 3 (2024)
- Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine
in General Practice: Development, Validation and Clinical Simulation Trial
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Authors:
Jules M. Janssen Daalen; Djoeke Doesburg,
Liesbeth Hunik,
Rogier Kessel,
Thomas Herngreen,
Dennis Knol,
Thony Ruys,
Bart J.F. van den Bemt,
Henk J. Schers
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 824-833, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3293
Issue No: Vol. 116, No. 3 (2024)
- Optimizing Early Clinical Investigations in Cancer Immunotherapy: The
Translational Journey of RG6292, a Novel, Selective Treg‐Depleting
Antibody-
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Authors:
Sara Belli; Maria Amann,
Lucy Hutchinson,
Laurène Pousse,
Afsaneh Abdolzade‐Bavil,
Nicole Justies,
Bjoern Jacobsen,
Corinne Ploix,
Eleni Tselempi,
Vinko Tosevski,
Hans Koll,
Gabriel Schnetzler,
Christophe Boetsch,
Estelle Marrer‐Berger
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 834-846, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3303
Issue No: Vol. 116, No. 3 (2024)
- Population Pharmacokinetic and Exposure–Response Modeling to Inform
Risankizumab Dose Selection in Patients With Ulcerative Colitis-
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Authors:
Neha Thakre; Aline Goebel,
Insa Winzenborg,
Ahmed A. Suleiman,
Ronilda D'Cunha,
Sven Mensing,
Wei Liu,
Yinuo Pang
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 847-857, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3330
Issue No: Vol. 116, No. 3 (2024)
- Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New
Findings from Model‐Based Assessment of Amlodipine-
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Authors:
Jie En Valerie Sia; Xuan Lai,
Wen Yao Mak,
Xinyi Wu,
Fan Zhang,
Cheng Cui,
Dongyang Liu,
Xiaoqiang Xiang
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 858-865, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3347
Issue No: Vol. 116, No. 3 (2024)
- A Score to Predict the Clinical Usefulness of Therapeutic Drug Monitoring:
Application to Oral Molecular Targeted Therapies in Cancer-
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Authors:
Arthur Géraud; David Combarel,
Christian Funck‐Brentano,
Quentin Beaulieu,
Noël Zahr,
Sophie Broutin,
Jean‐Philippe Spano,
Christophe Massard,
Benjamin Besse,
Paul Gougis
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 678-689, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3193
Issue No: Vol. 116, No. 3 (2024)
- From Dose to Exposure: Shifting the Paradigm of Pediatric Clinical
Pharmacology Research and Education-
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Authors:
Ronaldo Morales Junior; Victor Amajor,
Kelli Paice,
Kathryn E. Kyler,
H. Rhodes Hambrick,
Kathryn E. Pavia,
Andrew S. Haynes,
Felicia Gooden,
Gwendolyn M. Pais,
Kevin J. Downes,
Laura B. Ramsey,
Jonathan Wagner,
Sonya Tang Girdwood
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 515-517, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3281
Issue No: Vol. 116, No. 3 (2024)
- Optimizing Dosage in Pharmacotherapy—Missing the Forest for the
Trees-
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Susan M. Abdel‐Rahman; Andrew J. Farrell,
N. Seth Berry,
Gilbert J. Burckart
Abstract: Clinical Pharmacology &Therapeutics, Volume 116, Issue 3, Page 511-514, September 2024.
PubDate: 2024-08-20T09:24:17-07:00
DOI: 10.1002/cpt.3268
Issue No: Vol. 116, No. 3 (2024)
- The Rare Disease Moonshot: Paradigms Shift, Translational Medicine, and
Regulatory Science for the World's Rarest Conditions-
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Cécile Ollivier; Solange Corriol‐Rohou,
Marta del Álamo,
Roseline Favresse,
Johanna Kostenzer,
Mathieu Boudes,
Anton E. Ussi,
Klaus Viel,
R. Michael Linden,
Magda Chlebus
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-23T03:34:09-07:00
DOI: 10.1002/cpt.3428
- Development of a Multifaceted Program for Pharmacogenetics Adoption at an
Academic Medical Center: Practical Considerations and Lessons Learned-
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Tyler Shugg; Emma M. Tillman,
Amy M. Breman,
Jennelle C. Hodge,
Christine A. McDonald,
Reynold C. Ly,
Elizabeth J. Rowe,
Wilberforce Osei,
Tayler B. Smith,
Peter H. Schwartz,
John T. Callaghan,
Victoria M. Pratt,
Sheryl Lynch,
Michael T. Eadon,
Todd C. Skaar
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-21T09:53:58-07:00
DOI: 10.1002/cpt.3402
- Progress in Pharmacometrics Implementation and Regulatory Integration in
Africa: A Systematic Review-
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Bonginkosi S'fiso Ndzamba; Samuel Egieyeh,
Pius Fasinu
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-20T11:39:10-07:00
DOI: 10.1002/cpt.3415
- Model‐Informed Approaches to Optimizing Therapeutics in the African
Patient Populations-
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Mwila Mulubwa; Kelly Chibale
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-20T11:33:06-07:00
DOI: 10.1002/cpt.3425
- Towards Preanalytical Best Practices for Liquid Biopsy Studies: A BLOODPAC
Landscape Analysis-
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Christina M. Lockwood; Jason D. Merker,
Elizabeth Bain,
Caroline Compton,
Robert L. Grossman,
Donald Johann,
Frederick Jones,
Gregory Jones,
Matthew Kreifels,
Suzanne LeBlang,
Jerry S.H. Lee,
John Lyle,
Jean‐Francois Martini,
Lauren Saunders,
Howard Scher,
Stella Somiari,
Mark Stewart,
Jacob Vinson,
Lauren C. Leiman
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-20T10:18:45-07:00
DOI: 10.1002/cpt.3416
- Neuron‐Derived Extracellular Vesicles miRNA Profiles Identify Children
Who Experience Adverse Events after Ketamine Administration for Procedural
Sedation-
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Marianna Lucafò; Carlotta Bidoli,
Martina Franzin,
Erez Eitan,
Sara Rau,
Alessandro Amaddeo,
Alice Fachin,
Adamo Pio d'Adamo,
Giuliana Decorti,
Gabriele Stocco,
Egidio Barbi,
Giorgio Cozzi
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-20T09:34:50-07:00
DOI: 10.1002/cpt.3420
- Developmental Expression of Drug Transporters and Conjugating Enzymes
Involved in Enterohepatic Recycling: Implication for Pediatric Drug Dosing
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Aarzoo Thakur; Sandhya Subash,
Deepak Ahire,
Bhagwat Prasad
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-19T09:09:24-07:00
DOI: 10.1002/cpt.3409
- Getting the Dose Right in Drug Development for Rare Diseases: Barriers and
Enablers-
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Mariam A. Ahmed; Rajesh Krishna,
Noha Rayad,
Salwa Albusaysi,
Amitava Mitra,
Elizabeth Shang,
Yuen Yi Hon,
Bilal AbuAsal,
Rana Bakhaidar,
Youssef M. Roman,
Indranil Bhattacharya,
James Cloyd,
Munjal Patel,
Reena V. Kartha,
Islam R. Younis
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-16T12:44:29-07:00
DOI: 10.1002/cpt.3407
- Ongoing Pharmacological Developments in SLC6A1 Research & Treatment
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Melissa B. DeLeeuw; Jacob Tiller,
Jing‐Qiong Kang,
Amber Freed
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-16T06:28:13-07:00
DOI: 10.1002/cpt.3413
- Effects of Sacubitril/Valsartan on Survival in Patients with Heart Failure
and Significant Valvular Heart Disease-
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Donna Shu‐Han Lin; Ying‐Ting Chao,
Shu‐Lin Chuang,
Jen‐Kuang Lee,
Ting‐Tse Lin,
Lung‐Chun Lin,
Kuan‐Chih Huang,
Juey‐Jen Hwang
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-15T11:44:07-07:00
DOI: 10.1002/cpt.3417
- Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage
Optimization for Patients with Renal Insufficiency or Receiving Continuous
Renal Replacement Therapy-
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Emiel Leegwater; Lauren Baidjoe,
Erik B. Wilms,
Leo G. Visser,
Daniel J. Touw,
Brenda C. M. de Winter,
Mark G. J. de Boer,
Judith van Paassen,
Charlotte H. S. B. van den Berg,
Joffrey van Prehn,
Teun van Gelder,
Dirk Jan A. R. Moes
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-15T11:34:50-07:00
DOI: 10.1002/cpt.3421
- New Biomarkers for Renal Transporter‐Mediated Drug–Drug Interactions:
Metabolomic Effects of Cimetidine, Probenecid, Verapamil, and Rifampin in
Humans-
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Arne Gessner; Jörg König,
Pia Wenisch,
Markus R. Heinrich,
Peter Stopfer,
Martin F. Fromm,
Fabian Müller
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-15T09:50:45-07:00
DOI: 10.1002/cpt.3414
- Regulatory Pathways for Qualification and Acceptance of Digital Health
Technology‐Derived Clinical Trial Endpoints: Considerations for Sponsors
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Jessie P. Bakker; Elena S. Izmailova,
Aude Clement,
Steven Hoffmann,
Christopher Leptak,
Joseph P. Menetski,
John A. Wagner
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-15T09:07:12-07:00
DOI: 10.1002/cpt.3398
- Pediatric Rare Diseases Development in the Pharmaceutical Industry: An
International Consortium for Innovation and Quality in Pharmaceutical
Development, Clinical Pharmacology Leadership Group‐Pediatrics Working
Group, Rare Diseases Subteam Whitepaper Examining the Current Landscape
and Recommendations for the Future-
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Rajesh Krishna; Bernard Sebastien,
Solange Corriol‐Rohou,
S. Y. Amy Cheung,
Jing Liu,
Satyendra Suryawanshi
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-15T05:24:04-07:00
DOI: 10.1002/cpt.3422
- Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after
Kidney Transplantation with Population Pharmacokinetic Modeling-
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Suwasin Udomkarnjananun; Maaike R. Schagen,
Helena Volarević,
Daan van de Velde,
Marjolein Dieterich,
Maja Matic,
Carla C. Baan,
Marlies E. J. Reinders,
Brenda C. M. de Winter,
Dennis A. Hesselink
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-14T12:28:33-07:00
DOI: 10.1002/cpt.3419
- Comparative Analysis of Post‐Authorization Measures for Advanced
Medicinal Products Authorized in the European Union and in the United
States of America Between 2009 and 2023-
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Diana Mandslay; Diogo Almeida,
Adriana Marques,
João Rocha,
Frantisek Drafi,
Bruno Sepodes,
Carla Torre
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-14T06:04:54-07:00
DOI: 10.1002/cpt.3410
- PharmVar GeneFocus: CYP4F2
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Pablo Zubiaur; Cristina Rodríguez‐Antona,
Erin C. Boone,
Ann K. Daly,
Evangelia Eirini Tsermpini,
Lubna Q. Khasawneh,
Katrin Sangkuhl,
Jorge Duconge,
Mariana R. Botton,
Jessica Savieo,
Charity Nofziger,
Michelle Whirl‐Carrillo,
Teri E. Klein,
Andrea Gaedigk
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-13T12:18:36-07:00
DOI: 10.1002/cpt.3405
- Exposure Matching‐Based Pediatric Dose Selection for Drugs with Renal
Excretion – Lessons Learned from Pediatric Development of Direct Oral
Anticoagulants-
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Peng Zou; Tarek A. Leil
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-13T05:29:23-07:00
DOI: 10.1002/cpt.3396
- Item Response Theory Quantifies the Relationship Between Improvements in
Serum Phosphate and Patient‐Reported Outcomes in Adults With X‐Linked
Hypophosphatemia-
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Krina Mehta; Nathalie H. Gosselin,
Karl Insogna,
Olivier Barriere,
Emilia Quattrocchi,
Matthew W. Hruska,
Douglas Marsteller
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-12T12:34:43-07:00
DOI: 10.1002/cpt.3406
- Model‐informed Evidence for Clinical Non‐inferiority of
Every‐2‐Weeks Versus Standard Weekly Dosing Schedule of Cetuximab in
Metastatic Colorectal Cancer-
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Ana‐Marija Milenković‐Grišić; Siobhán Hayes,
Colm Farrell,
Yoshihiro Kuroki,
Mauro Bertolino,
Karthik Venkatakrishnan,
Pascal Girard
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-12T05:40:27-07:00
DOI: 10.1002/cpt.3345
- Questioning the Design of Non‐Inferiority Trials: The Strange Case for
Therapeutic Drug Monitoring Absence in Phase III Trials-
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Florian Lemaitre; Sébastien Lalanne,
Marie‐Clémence Verdier
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-09T03:58:15-07:00
DOI: 10.1002/cpt.3408
- The Value of Clinical Pharmacogenomic Guidelines That Recommend Standard
of Care Over Genotype‐Based Prescribing-
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Roseann S. Donnelly; Michelle Whirl‐Carrillo,
Teri E. Klein,
Kelly E. Caudle
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-08T08:51:06-07:00
DOI: 10.1002/cpt.3401
- The Effect of Low‐Dose Colchicine on the Phenotype and Function of
Neutrophils and Monocytes in Patients with Chronic Coronary Artery
Disease: A Double‐Blind Randomized Placebo‐Controlled Cross‐Over
Study-
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Helin Tercan; Amber van Broekhoven,
Harsh Bahrar,
Tjerk Opstal,
Benjamin C. Cossins,
Nils Rother,
Laura Rodwell,
Siroon Bekkering,
Saloua El Messaoudi,
Niels P. Riksen,
Jan H. Cornel
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-08T05:14:02-07:00
DOI: 10.1002/cpt.3394
- Coproporphyrin‐I as a Selective OATP1B Biomarker Can Be Used to
Delineate the Mechanisms of Complex Drug–Drug Interactions: Cedirogant
Case Study-
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Ryota Kikuchi; Yuli Qian,
Mohamed Badawi,
John P. Savaryn,
Shashikanth Gannu,
Ann Eldred,
Shuai Hao,
Ahmed Hamed Salem,
Wei Liu,
Cheri E. Klein,
Mohamed‐Eslam F. Mohamed
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-05T04:01:11-07:00
DOI: 10.1002/cpt.3399
- Pharmacogenomic Prescribing Guidelines: Are They Always Useful'
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Magnus Ingelman‐Sundberg
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-05T02:09:10-07:00
DOI: 10.1002/cpt.3403
- Recent Advances Addressing the Challenges of Precision Dosing
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Iris K. Minichmayr; Tomoyuki Mizuno,
Srijib Goswami,
Richard W. Peck,
Thomas M. Polasek,
the American Society of Clinical Pharmacology Therapeutics Precision Dosing Community
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-08-01T01:34:33-07:00
DOI: 10.1002/cpt.3365
- Phenoconversion Due to Drug–Drug Interactions in CYP2C19 Genotyped
Healthy Volunteers-
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Kenza Abouir; Nadia Exquis,
Yvonne Gloor,
Youssef Daali,
Caroline Flora Samer
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-29T11:48:22-07:00
DOI: 10.1002/cpt.3378
- Dosage Optimization: A Regulatory Perspective for Developing Oncology
Drugs-
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Atiqur Rahman; Mirat Shah,
Stacy S. Shord
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-29T04:09:33-07:00
DOI: 10.1002/cpt.3373
- A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted
Covalent Inhibitors vs. Reversible Inhibitors in Oncology-
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Huy X. Ngo; Yue Winnie Wen,
Swathi Pisupati,
Weize Huang,
Sandhya Mandlekar
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-28T09:45:09-07:00
DOI: 10.1002/cpt.3390
- Congenital and Fetal Effects After Mifepristone Exposure and Continuation
of Pregnancy: A Systematic Review-
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Joseph V. Turner; Deborah Garratt,
Anna Barwick,
Lucas A. McLindon,
M. Joy Spark,
Angela Smith
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-25T12:13:49-07:00
DOI: 10.1002/cpt.3392
- PharmVar GeneFocus: CYP2A6
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Alec W.R. Langlois; Meghan J. Chenoweth,
David Twesigomwe,
Giada Scantamburlo,
Michelle Whirl‐Carrillo,
Katrin Sangkuhl,
Teri E. Klein,
Charity Nofziger,
Rachel F. Tyndale,
Andrea Gaedigk
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-25T12:00:00-07:00
DOI: 10.1002/cpt.3387
- A Phase 1 Assessment of the Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of (2R,6R)‐Hydroxynorketamine in Healthy Volunteers-
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Shruti M. Raja; Jeffrey T. Guptill,
Michelle Mack,
Marni Peterson,
Stephen Byard,
Robert Twieg,
Lynn Jordan,
Natalie Rich,
Richard Castledine,
Samuel Bourne,
Martin Wilmshurst,
Sarah Oxendine,
Satya G.C. Avula,
Helen Zuleta,
Paul Quigley,
Sheila Lawson,
Stephen J. McQuaker,
Reza Ahmadkhaniha,
Lawrence G. Appelbaum,
Kevin Kowalski,
Chineta T. Barksdale,
Brandon T. Gufford,
Asaad Awan,
Alfredo R. Sancho,
Max C. Moore,
Karim Berrada,
Gregory B. Cogan,
Jesse DeLaRosa,
Jeanne Radcliffe,
Maryland Pao,
Michelle Kennedy,
Quentin Lawrence,
Lisa Goldfeder,
Leslie Amanfo,
Panos Zanos,
Jessica R. Gilbert,
Patrick J. Morris,
Ruin Moaddel,
Todd D. Gould,
Carlos A. Zarate Jr,
Craig J. Thomas
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-25T11:15:03-07:00
DOI: 10.1002/cpt.3391
- Cannabidiol Increases Psychotropic Effects and Plasma Concentrations of
Δ9‐Tetrahydrocannabinol Without Improving Its Analgesic Properties-
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Authors:
Andriy A. Gorbenko; Jules A.A.C. Heuberger,
Linda E. Klumpers,
Marieke L. de Kam,
Pamela K. Strugala,
Saco J. de Visser,
Geert J. Groeneveld
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-25T09:49:54-07:00
DOI: 10.1002/cpt.3381
- Racial and Ethnic Disparities in Antihypertensive Medication Prescribing
Patterns and Effectiveness-
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Authors:
Slavina B. Goleva; Ariel Williams,
David J. Schlueter,
Jacob M. Keaton,
Tam C. Tran,
Bennett J. Waxse,
Tracey M. Ferrara,
Thomas Cassini,
Huan Mo,
Joshua C. Denny
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-25T03:55:41-07:00
DOI: 10.1002/cpt.3360
- Impact of Priority Review Voucher Eligibility on Research and Development
of Medical Countermeasures-
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Authors:
Stephanie Wang; Georg Hahn,
Aaron S. Kesselheim
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-23T09:13:32-07:00
DOI: 10.1002/cpt.3388
- Integrated Applied Clinical Pharmacology in the Advancement of Rare and
Ultra‐Rare Disease Therapeutics-
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Steven Ryder
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T12:25:25-07:00
DOI: 10.1002/cpt.3382
- Correction to “Effect of CYP4F2, VKORC1, and CYP2C9 in Influencing
Coumarin Dose: A Single‐Patient Data Meta‐Analysis in More Than 15,000
Individuals”-
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Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T11:33:10-07:00
DOI: 10.1002/cpt.3395
- Ticagrelor modestly raises plasma riboflavin concentration in humans and
inhibits riboflavin transport by BCRP and MRP4-
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Feng Deng; Kreetta Hämäläinen,
Minna Lehtisalo,
Mikko Neuvonen,
Mikko Niemi
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T11:19:05-07:00
DOI: 10.1002/cpt.3384
- Solanidine Metabolites as Diet‐Derived Biomarkers of CYP2D6‐Mediated
Tamoxifen Metabolism in Breast Cancer Patients-
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Samantha Medwid; Ute I. Schwarz,
Yun‐Hee Choi,
Denise Keller,
Cameron Ross,
Richard B. Kim
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T09:34:47-07:00
DOI: 10.1002/cpt.3380
- Population Pharmacokinetic Modeling and Exposure–Response Analysis for
the Antibody–Drug Conjugate Enfortumab Vedotin in Locally Advanced or
Metastatic Urothelial Carcinoma-
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Peiying Zuo; Peter Bonate,
Amit Garg,
Maria Matsangou,
Mei Tang
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T09:00:32-07:00
DOI: 10.1002/cpt.3383
- From Challenge to Opportunity: How Shwachman–Diamond Syndrome Became a
Promising Target for Therapy Development-
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Eszter S. Hars; Lisa J. McReynolds
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T08:50:28-07:00
DOI: 10.1002/cpt.3393
- Disentangling Anti‐Tumor Response of Immunotherapy Combinations:
A Physiologically Based Framework for V937 Oncolytic Virus and
Pembrolizumab-
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Aymara Sancho‐Araiz; Zinnia P. Parra‐Guillen,
Iñaki F. Troconiz,
Tomoko Freshwater
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-22T07:29:19-07:00
DOI: 10.1002/cpt.3379
- Evaluating the Effect of Estimating Renal Function With the CKD‐EPI 2021
Equation on the ABCD‐GENE Score for Clopidogrel Response Prediction-
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Maryam Jamal AlSaeed; Cameron D. Thomas,
Francesco Franchi,
Ellen C. Keeley,
Julio D. Duarte,
Yan Gong,
Joseph S. Rossi,
Amber L. Beitelshees,
George A. Stouffer,
Craig R. Lee,
Dominick J. Angiolillo,
Larisa H. Cavallari
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-19T04:39:28-07:00
DOI: 10.1002/cpt.3385
- PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose
Adjustments in Pediatric Populations Co‐Administered with CYP3A4
Inhibitors-
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Kenichi Umehara; Neil Parrott,
Emilie Schindler,
Valentin Legras,
Georgina Meneses‐Lorente
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-18T06:55:53-07:00
DOI: 10.1002/cpt.3386
- Return to SENDer: The Submitted Electronic Data for Nonclinical
Cardiovascular Studies is Not Facilitating Transparency, Translation or
Innovation-
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Matthew M. Abernathy; Derek D. Best,
Derek J. Leishman
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-17T03:38:38-07:00
DOI: 10.1002/cpt.3389
- Integrated Population Exposure–Response of Dolutegravir in HIV‐1
Supports Bridging of Clinical Response Influenced by Relevant Intrinsic
and Extrinsic Patient Characteristics-
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Hardik Chandasana; Mark Bush,
Cindy Vavro,
Jenny Huang,
Mounir Ait‐Khaled,
Brian Wynne,
Sherene Min,
Rashmi Mehta
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-16T09:40:01-07:00
DOI: 10.1002/cpt.3370
- Extended Model‐Informed Drug Development: Beyond Clinical Trials and
Regulatory Approval-
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Mohamed A. Kamal; Samit Ganguly,
Ananth Kadambi,
Patrick F. Smith
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-15T10:14:41-07:00
DOI: 10.1002/cpt.3357
- Predicting Survival in Patients with Advanced NSCLC Treated with
Atezolizumab Using Pre‐ and on‐Treatment Prognostic Biomarkers-
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Sébastien Benzekry; Mélanie Karlsen,
Célestin Bigarré,
Abdessamad El Kaoutari,
Bruno Gomes,
Martin Stern,
Ales Neubert,
Rene Bruno,
François Mercier,
Suresh Vatakuti,
Peter Curle,
Candice Jamois
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-12T11:19:13-07:00
DOI: 10.1002/cpt.3371
- Limitations Reported in Evaluating Effectiveness of Risk Minimization
Measures in the EU during 2018–2021: A Qualitative Analysis of
Industry‐Sponsored Post‐Authorization Safety Studies-
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Renske J. Grupstra; Thomas Goedecke,
Helga Gardarsdottir
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-12T01:57:45-07:00
DOI: 10.1002/cpt.3369
- Pseudo‐Worsening of Kidney Function Due to Inhibition of Renal
Creatinine Secretion: Quality of Information Provided in Prescribing
Information/SmPC-
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Michael I. Sponfeldner; Wahram Andrikyan,
Renke Maas,
Martin F. Fromm
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-11T02:49:11-07:00
DOI: 10.1002/cpt.3374
- New Horizons of Model Informed Drug Development in Rare Diseases Drug
Development-
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Amitava Mitra; Nessy Tania,
Mariam A. Ahmed,
Noha Rayad,
Rajesh Krishna,
Salwa Albusaysi,
Rana Bakhaidar,
Elizabeth Shang,
Maria Burian,
Michelle Martin‐Pozo,
Islam R. Younis
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-11T02:35:45-07:00
DOI: 10.1002/cpt.3366
- Model‐Informed Reinforcement Learning for Enabling Precision Dosing
Via Adaptive Dosing-
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Elena Maria Tosca; Alessandro De Carlo,
Davide Ronchi,
Paolo Magni
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-11T01:34:31-07:00
DOI: 10.1002/cpt.3356
- Pharmacokinetics and Exposure–Response Analyses to Support Dose
Selection of Upadacitinib in Crohn's Disease-
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Sumit Bhatnagar; Louisa Schlachter,
Doerthe Eckert,
Sven Stodtmann,
Wei Liu,
Ana P. Lacerda,
Mohamed‐Eslam F. Mohamed
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-09T08:54:17-07:00
DOI: 10.1002/cpt.3359
- Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug
Development: Current Practices and Industry Perspectives: White Paper-
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Aarti Sawant‐Basak; Shweta Urva,
Jatinder Kaur Mukker,
Sebastian Haertter,
Dean Mariano,
Dolly A. Parasrampuria,
Kosalaram Goteti,
Ravi Shankar Prasad Singh,
Manoj Chiney,
Michael Z. Liao,
Sandy S. Chang,
Rashmi Mehta
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-07T09:58:33-07:00
DOI: 10.1002/cpt.3350
- Reply to: “Therapeutic Drug Monitoring of Oral Oncology Drugs: Another
Example of Maslow's Hammer” and “Therapeutic Drug Monitoring of Oral
Oncology Drugs: Finding the Right Nails”-
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David Combarel; Arthur Geraud,
Paul Gougis
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-05T11:28:48-07:00
DOI: 10.1002/cpt.3367
- Systemic Treatment of Body‐Wide Duchenne Muscular Dystrophy Symptoms
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Patryk Konieczny
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-04T09:49:03-07:00
DOI: 10.1002/cpt.3363
- Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific
T‐Cell Engagers Development in Oncology-
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Mohamed Elmeliegy; Joseph Chen,
Aruna Dontabhaktuni,
Allison Gaudy,
Georgi I. Kapitanov,
Junyi Li,
Sabiha R. Mim,
Sharad Sharma,
Qin Sun,
Sihem Ait‐Oudhia
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-04T01:55:16-07:00
DOI: 10.1002/cpt.3361
- Real‐World Evidence to Support EU Regulatory Decision Making—Results
From a Pilot of Regulatory Use Cases-
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Stefanie Prilla; Sophie Groeneveld,
Alexandra Pacurariu,
María Clara Restrepo‐Méndez,
Patrice Verpillat,
Carla Torre,
Christian Gartner,
Peter G. M. Mol,
Frauke Naumann‐Winter,
Kieran C. Breen,
Nathalie Gault,
Liana Gross‐Martirosyan,
Sylvie Benchetrit,
Brian Aylward,
Violeta Stoyanova‐Beninska,
Maura O'Donovan,
Sabine Straus,
Jesper Kjaer,
Peter Arlett
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-04T01:39:00-07:00
DOI: 10.1002/cpt.3355
- From Plan to Pivot: How Model‐Informed Drug Development Shaped the Dose
Strategy of the Zibotentan/Dapagliflozin ZENITH Trials-
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Anne‐Kristina Mercier; Sebastian Ueckert,
Mikael Sunnåker,
Bengt Hamrén,
Phil Ambery,
Peter J. Greasley,
Magnus Åstrand
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-03T11:04:04-07:00
DOI: 10.1002/cpt.3362
- Enhancing External Control Arm Analyses through Data Calibration and
Hybrid Designs-
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Sebastian Schneeweiss
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-02T12:10:16-07:00
DOI: 10.1002/cpt.3364
- Age‐Dependent Abundance of CYP450 Enzymes Involved in Metronidazole
Metabolism: Application to Pediatric PBPK Modeling-
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Authors:
Md Masud Parvez; Aarzoo Thakur,
Aanchal Mehrotra,
Stephani Stancil,
Robin E. Pearce,
Abdul Basit,
J. Steven Leeder,
Bhagwat Prasad
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-02T07:40:33-07:00
DOI: 10.1002/cpt.3354
- Therapeutic Drug Monitoring of Oral Oncology Drugs: Finding the Right
Nails-
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Authors:
Niels A. D. Guchelaar; Maud B. A. van der Kleij,
Neeltje Steeghs,
Alwin D. R. Huitema,
Ron H. J. Mathijssen,
Stijn L. W. Koolen
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-01T11:59:32-07:00
DOI: 10.1002/cpt.3368
- Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for
CYP2D6, ADRB1, ADRB2, ADRA2C, GRK4, and GRK5 Genotypes and Beta‐Blocker
Therapy-
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Authors:
Julio D. Duarte; Cameron D. Thomas,
Craig R. Lee,
Rachel Huddart,
Jose A. G. Agundez,
Jordan F. Baye,
Andrea Gaedigk,
Teri E. Klein,
David E. Lanfear,
Andrew A. Monte,
Mohamed Nagy,
Matthias Schwab,
C. Michael Stein,
Chakradhara Rao S. Uppugunduri,
Ron H. N. van Schaik,
Roseann S. Donnelly,
Kelly E. Caudle,
Jasmine A. Luzum
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-01T09:39:03-07:00
DOI: 10.1002/cpt.3351
- Getting the Dose Right: ASCPT Translational Precision Medicine (TPM)
Network Perspectives-
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Mariam Ahmed; Hazem E. Hassan
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-07-01T05:44:53-07:00
DOI: 10.1002/cpt.3358
- Informing the Recommended Phase III Dose of Alnuctamab, a CD3 × BCMA
T‐Cell Engager, Using Population Pharmacokinetics and
Exposure–Response Analysis-
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Brian Kiesel; Mayu Osawa,
Madhan Masilamani,
Merav Bar,
Kevin Hsu,
Colin Godwin,
Michael Burgess,
Manisha Lamba,
Allison Gaudy
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-06-28T12:34:49-07:00
DOI: 10.1002/cpt.3353
- Pharmacokinetics, Mass Balance, Safety, and Tolerability of Obeldesivir in
Healthy Participants-
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Olena Anoshchenko; Mazin Abdelghany,
Amos Lichtman,
Ran Duan,
Henry Chen,
Naveed A. Shaik,
Chi‐Chi Peng,
Qin Yue,
Raju Subramanian,
Robert H. Hyland,
Santosh Davies,
Keelin Castellanos,
Lily Mak,
Gong Shen,
Deqing Xiao,
Luzelena Caro,
Helen Winter,
Joe Llewellyn,
Rita Humeniuk
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-06-28T05:10:00-07:00
DOI: 10.1002/cpt.3337
- Low Nirmatrelvir and Ritonavir Exposure through Breastmilk: Analyzing Milk
Concentrations and Infant Risk-
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Jean Dai; Taylor Fuquay,
Samuel Huseman,
Dhavalkumar Patel,
Palika Datta,
Kaytlin Krutsch
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-06-25T12:09:42-07:00
DOI: 10.1002/cpt.3352
- Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy
Volunteers and Patients with Chronic Kidney Disease-
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Pamela Navarro‐Gonzales; Tomas Ganz,
Pablo E. Pergola,
Anna Zuk,
Kevin Dykstra
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-06-25T10:49:32-07:00
DOI: 10.1002/cpt.3342
- Assessing the Performance of In silico Tools and Molecular Dynamics
Simulations for Predicting Pharmacogenetic Variant Impact-
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Authors:
Maryam Jamal AlSaeed; Peter Ramdhan,
Jean Gabriel Malave,
Islam Eljilany,
Taimour Langaee,
Caitrin W. McDonough,
Gustavo Seabra,
Chenglong Li,
Larisa H. Cavallari
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-06-18T11:44:15-07:00
DOI: 10.1002/cpt.3348
- Multicenter Pharmacokinetic and Pharmacodynamic Study of Pembrolizumab for
Non‐small‐Cell Lung Cancer in Patients Aged 75 Years and Older-
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Authors:
Shigehiro Yagishita; Yuta Yamanaka,
Takayasu Kurata,
Kageaki Watanabe,
Yukio Hosomi,
Hidehito Horinouchi,
Yuichiro Ohe,
Yoshiro Nakahara,
Katsuhiko Naoki,
Tetsuhiko Asao,
Kazuhisa Takahashi,
Sho Saeki,
Takuro Sakagami,
Kazuhisa Nakashima,
Yukari Tsubata,
Yu Fujita,
Hiroshi Wakui,
Megumi Furuta,
Jun Sakakibara Konishi,
Mayu Ohuchi,
Yuichi Ando,
Hidenori Mizugaki,
Akinobu Hamada
Abstract: Clinical Pharmacology &Therapeutics, EarlyView.
PubDate: 2024-06-17T10:34:28-07:00
DOI: 10.1002/cpt.3339
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