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- Issue Information
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Volume 13, Issue 8, Page 1281-1284, August 2024.
PubDate: 2024-08-17T08:22:02-07:00
DOI: 10.1002/psp4.12991
Issue No: Vol. 13, No. 8 (2024)
- A stacking ensemble machine learning model for evaluating cardiac toxicity
of drugs based on in silico biomarkers
Authors:
Yunendah Nur Fuadah; Ali Ikhsanul Qauli,
Muhammad Adnan Pramudito,
Aroli Marcellinus,
Ulfa Latifa Hanum,
Ki Moo Lim
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-26T04:40:18-07:00
DOI: 10.1002/psp4.13229
- Development and comparison of model‐integrated evidence approaches for
bioequivalence studies with pharmacokinetic end points
Authors:
Xiaomei Chen; Henrik B. Nyberg,
Mark Donnelly,
Liang Zhao,
Lanyan Fang,
Mats O. Karlsson,
Andrew C. Hooker
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-23T04:45:33-07:00
DOI: 10.1002/psp4.13216
- Quantitative systems pharmacology model of α‐synuclein pathology in
Parkinson's disease‐like mouse for investigation of passive
immunotherapy mechanisms
Authors:
Olga Ivanova; Tatiana Karelina
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-23T04:28:58-07:00
DOI: 10.1002/psp4.13223
- Modeling of HIV‐1 prophylactic efficacy and toxicity with islatravir
shows non‐superiority for oral dosing, but promise as a subcutaneous
implant
Authors:
Hee‐yeong Kim; Lanxin Zhang,
Craig W. Hendrix,
Jessica E. Haberer,
Max von Kleist
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-20T10:05:01-07:00
DOI: 10.1002/psp4.13212
- Simulation‐based evaluation of the Pharmpy Automatic Model Development
tool for population pharmacokinetic modeling in early clinical drug
development
Authors:
Zrinka Duvnjak; Franziska Schaedeli Stark,
Valérie Cosson,
Sylvie Retout,
Emilie Schindler,
João A. Abrantes
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-18T12:00:00-07:00
DOI: 10.1002/psp4.13213
- Bayesian sparse regression for exposure–response analyses of efficacy
and safety endpoints to justify the clinical dose of valemetostat for
adult T‐cell leukemia/lymphoma
Authors:
Masato Fukae; James Rogers,
Ramon Garcia,
Masaya Tachibana,
Takako Shimizu
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-18T11:38:21-07:00
DOI: 10.1002/psp4.13203
- Enhancing inclusivity in clinical trials: Model‐informed drug
development for pregnant individuals in the era of personalized medicine
Authors:
André Dallmann; Peter L. Bonate,
Janelle Burnham,
Blessy George,
Lynne Yao,
Jane Knöchel
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-18T11:27:59-07:00
DOI: 10.1002/psp4.13218
- Indirect modeling of derived outcomes: Are minor prediction discrepancies
a cause for concern'
Authors:
John P. Prybylski
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-14T06:43:07-07:00
DOI: 10.1002/psp4.13219
- EMA perspective on the value of model‐informed drug development for
labeling recommendations regarding medicine use during pregnancy and
breastfeeding
Authors:
Efthymios Manolis; Flora Tshinanu Musuamba,
Corinne S. de Vries,
Pieter J. Colin,
Martin B. Oleksiewicz
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-13T07:04:53-07:00
DOI: 10.1002/psp4.13214
- Characterization of mavacamten pharmacokinetics in patients with
hypertrophic cardiomyopathy to inform dose titration
Authors:
Peter Chang; Vidya Perera,
David H. Salinger,
Samira Merali,
Neelima Thanneer,
Hyunmoon Back,
Julie D. Seroogy,
Daniel D. Gretler,
Amy J. Sehnert,
Maria Palmisano,
Amit Roy
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-08-13T03:43:51-07:00
DOI: 10.1002/psp4.13197
- Automated Poisson regression exposure–response analysis for binary
outcomes with PoissonERM
Authors:
Yuchen Wang; Luke Fostvedt,
Jessica Wojciechowski,
Donald Irby,
Timothy Nicholas
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-31T09:30:31-07:00
DOI: 10.1002/psp4.13207
- Population pharmacokinetics of total and unbound valemetostat and platelet
dynamics in healthy volunteers and patients with non‐Hodgkin lymphoma
Authors:
Masato Fukae; Kyle Baron,
Masaya Tachibana,
John Mondick,
Takako Shimizu
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-30T03:39:53-07:00
DOI: 10.1002/psp4.13201
- Population pharmacokinetic modeling of sufentanil in adult Korean patients
undergoing cardiopulmonary bypass surgery
Authors:
Vipada Khaowroongrueng; Kuk Hui Son,
Sang‐Min Lee,
JiYeon Lee,
Chun‐Gon Park,
Seok In Lee,
Dongseong Shin,
Kwang‐Hee Shin
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-23T12:13:44-07:00
DOI: 10.1002/psp4.13205
- Correction to: Model‐based estimates of tumor growth inhibition metrics
are time‐independent: A reply to Mistry
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-23T12:05:58-07:00
DOI: 10.1002/psp4.13209
- Correction to: Simulations to predict clinical trial outcome of
bevacizumab plus chemotherapy vs. chemotherapy alone in patients with
first‐line gastric cancer and elevated plasma VEGF‐A
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-23T12:05:25-07:00
DOI: 10.1002/psp4.13210
- Exposure–response modeling for nausea incidence for cotadutide using a
Markov modeling approach
Authors:
Hongtao Yu; Sebastian Ueckert,
Lina Zhou,
Jenny Cheng,
Darren Robertson,
Lars Hansen,
Armando Flor,
Victoria Parker,
Bengt Hamrén,
Anis A. Khan
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-23T09:40:37-07:00
DOI: 10.1002/psp4.13194
- A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II
dose selection
Authors:
Azar Shahraz; Mark Penney,
Juliana Candido,
Grace Opoku‐Ansah,
Melanie Neubauer,
Jim Eyles,
Oluwaseun Ojo,
Nelson Liu,
Nadia M. Luheshi,
Alex Phipps,
Karthick Vishwanathan
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-23T05:24:33-07:00
DOI: 10.1002/psp4.13204
- A physiologically‐based pharmacokinetic modeling approach for dosing
amiodarone in children on ECMO
Authors:
Venkata K. Yellepeddi; John Porter Hunt,
Danielle J. Green,
Autumn McKnite,
Aviva Whelan,
Kevin Watt
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-21T07:36:13-07:00
DOI: 10.1002/psp4.13199
- A guide to developing population files for physiologically‐based
pharmacokinetic modeling in the Simcyp Simulator
Authors:
Liam Curry; Sarah Alrubia,
Frederic Y. Bois,
Ruth Clayton,
Eman El‐ Khateeb,
Trevor N. Johnson,
Muhammad Faisal,
Sibylle Neuhoff,
Kris Wragg,
Amin Rostami‐Hodjegan
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-18T09:54:55-07:00
DOI: 10.1002/psp4.13202
- Time‐varying covariates, overadjustment bias and mediation in
pharmacokinetic/pharmacodynamic modeling
Authors:
Sebastiaan Camiel Goulooze; Nelleke Snelder
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-16T12:09:29-07:00
DOI: 10.1002/psp4.13200
- Bridging pharmacology and neural networks: A deep dive into neural
ordinary differential equations
Authors:
Idris Bachali Losada; Nadia Terranova
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-11T10:45:13-07:00
DOI: 10.1002/psp4.13149
- A literature review of drug transport mechanisms during lactation
Authors:
Christine Gong; Lynn N. Bertagnolli,
David W. Boulton,
Paola Coppola
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-07T12:00:00-07:00
DOI: 10.1002/psp4.13195
- Dose optimization of cefazolin in South African children undergoing
cardiac surgery with cardiopulmonary bypass
Authors:
Manna Semere Gebreyesus; Alexandra Dresner,
Lubbe Wiesner,
Ettienne Coetzee,
Tess Verschuuren,
Roeland Wasmann,
Paolo Denti
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-04T02:05:26-07:00
DOI: 10.1002/psp4.13196
- Type 1 diabetes prevention clinical trial simulator: Case reports of
model‐informed drug development tool
Authors:
Juan Francisco Morales; Marian Klose,
Yannick Hoffert,
Jagdeep T. Podichetty,
Jackson Burton,
Stephan Schmidt,
Klaus Romero,
Inish O'Doherty,
Frank Martin,
Martha Campbell‐Thompson,
Michael J. Haller,
Mark A. Atkinson,
Sarah Kim
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-07-03T08:49:19-07:00
DOI: 10.1002/psp4.13193
- Full random effects models (FREM): A practical usage guide
Authors:
E. Niclas Jonsson; Joakim Nyberg
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-27T09:29:16-07:00
DOI: 10.1002/psp4.13190
- Combining data on the bioavailability of midazolam and
physiologically‐based pharmacokinetic modeling to investigate intestinal
CYP3A4 ontogeny
Authors:
Trevor N. Johnson; Hannah K. Batchelor,
Jan Goelen,
Richard D. Horniblow,
Jean Dinh
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-26T02:30:52-07:00
DOI: 10.1002/psp4.13192
- Population pharmacokinetics of valproic acid in children with epilepsy:
Implications for dose tailoring when switching from oral syrup to
sustained‐release tablets
Authors:
Wei‐Jun Wang; Yue Li,
Ya‐Hui Hu,
Jie Wang,
Yuan‐Yuan Zhang,
Lin Fan,
Hao‐Ran Dai,
Hong‐Li Guo,
Xuan‐Sheng Ding,
Feng Chen
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-24T11:05:27-07:00
DOI: 10.1002/psp4.13191
- Impact of obesity and roux‐en‐Y gastric bypass on the pharmacokinetics
of (R)‐ and (S)‐omeprazole and intragastric pH
Authors:
Leandro F. Pippa; Valvanera Vozmediano,
Lieke Mitrov‐Winkelmolen,
Daan Touw,
Amira Soliman,
Rodrigo Cristofoletti,
Wilson Salgado Junior,
Natalia Valadares de Moraes
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-24T08:43:52-07:00
DOI: 10.1002/psp4.13189
- Physiologically‐based pharmacokinetic modeling predicts the drug
interaction potential of GLS4 in co‐administered with ritonavir
Authors:
Zexu Sun; Nan Zhao,
Ran Xie,
Bo Jia,
Junyu Xu,
Lin Luo,
Yulei Zhuang,
Yuyu Peng,
Xinchang Liu,
Yingjun Zhang,
Xia Zhao,
Zhaoqian Liu,
Yimin Cui
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-20T10:43:30-07:00
DOI: 10.1002/psp4.13184
- Hepatic OATP1B zonal distribution: Implications for rifampicin‐mediated
drug–drug interactions explored within a PBPK framework
Authors:
Mattie Hartauer; William A. Murphy,
Kim L. R. Brouwer,
Roz Southall,
Sibylle Neuhoff
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-19T08:49:01-07:00
DOI: 10.1002/psp4.13188
- Simulating realistic patient profiles from pharmacokinetic models by a
machine learning postprocessing correction of residual variability
Authors:
Christos Kaikousidis; Robert R. Bies,
Aristides Dokoumetzidis
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-14T09:45:09-07:00
DOI: 10.1002/psp4.13182
- Quantification of the effect of GLP‐1R agonists on body weight using
in vitro efficacy information: An extension of the Hall body composition
model
Authors:
Rolien Bosch; Eric J. G. Sijbrands,
Nelleke Snelder
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-12T09:39:19-07:00
DOI: 10.1002/psp4.13183
- A bootstrapping method to optimize go/no‐go decisions from single‐arm,
signal‐finding studies in oncology
Authors:
Raunak Dutta; Aparna Mohan,
Jacqueline Buros‐Novik,
Gregory Goldmacher,
Omobolaji O. Akala,
Brian Topp
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-11T10:04:06-07:00
DOI: 10.1002/psp4.13161
- Physiologically‐based pharmacokinetic modeling of pantoprazole to
evaluate the role of CYP2C19 genetic variation and obesity in the
pediatric population
Authors:
Elizabeth J. Thompson,
Angela Jeong,
Victória E. Helfer,
Valentina Shakhnovich,
Andrea Edginton,
Stephen J. Balevic,
Laura P. James,
David N. Collier,
Ravinder Anand,
Daniel Gonzalez,
the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee,
Daniel K. Benjamin Jr; Phyllis Kennel,
Cheryl Alderman,
Zoe Sund,
Kylie Opel,
Rose Beci,
Chi D. Hornik,
Gregory L. Kearns,
Ian M. Paul,
Janice Sullivan,
Kelly Wade,
Paula Delmore,
Susan Abdel‐Rahman,
Elizabeth Payne,
Lily Chen,
Gina Simone,
Kathleen O’Connor,
Jennifer Cermak,
Lawrence Taylor,
Thomas Green,
Perdita Taylor‐Zapata,
Greg Kearns,
Ian Paul,
Julie Autmizguine,
Edmund Capparelli,
Kanecia Zimmerman,
Rachel Greenberg,
Terren Green,
Chad Livingston,
Tedryl Bumpass,
Lee Howard,
Jaylene Weigel,
Nancy Darden‐Saad
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-06-04T09:53:27-07:00
DOI: 10.1002/psp4.13167
- A pharmacokinetic framework describing antibiotic adsorption to
cardiopulmonary bypass devices
Authors:
Conor J. O'Hanlon; Nick Holford,
Brian J. Anderson,
Mark Greaves,
Lee Blackburn,
Malcolm D. Tingle,
Jacqueline A. Hannam
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-30T12:44:34-07:00
DOI: 10.1002/psp4.13180
- Population pharmacokinetic modeling of sotatercept in healthy participants
and patients with pulmonary arterial hypertension
Authors:
Sihem Ait‐Oudhia; David Jaworowicz,
Ziheng Hu,
Sébastien Bihorel,
Shuai Hu,
Budda Balasubrahmanyam,
Bipin Mistry,
Janethe de Oliveira Pena,
Larissa Wenning,
Ferdous Gheyas
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-29T09:09:11-07:00
DOI: 10.1002/psp4.13166
- Tipifarnib physiologically‐based pharmacokinetic modeling to assess
drug–drug interaction, organ impairment, and biopharmaceutics in healthy
subjects and cancer patients
Authors:
Noriko Okudaira; Howard Burt,
Amitava Mitra
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-28T09:54:43-07:00
DOI: 10.1002/psp4.13165
- Development of a SARS‐CoV‐2 viral dynamic model for patients with
COVID‐19 based on the amount of viral RNA and viral titer
Authors:
Daichi Yamaguchi; Ryosuke Shimizu,
Ryuji Kubota
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-23T09:19:19-07:00
DOI: 10.1002/psp4.13164
- A novel Bayesian generative approach for estimating tumor dynamics from
published studies
Authors:
Arya Pourzanjani; Saurabh Modi,
Jamie Connarn,
Xinwen Zhang,
Vijay Upreti,
Chih‐Wei Lin,
Khamir Mehta
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-22T10:19:24-07:00
DOI: 10.1002/psp4.13163
- Item performance of the scale for the assessment and rating of ataxia in
rare and ultra‐rare genetic ataxias
Authors:
Alzahra Hamdan; Andrew C. Hooker,
Xiaomei Chen,
Andreas Traschütz,
Rebecca Schüle,
ARCA Study Group,
EVIDENCE‐RND consortium,
Matthis Synofzik,
Mats O. Karlsson
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-21T12:04:53-07:00
DOI: 10.1002/psp4.13162
- Recommendation of mavacamten posology by model‐based analyses in adults
with obstructive hypertrophic cardiomyopathy
Authors:
Samira Merali; David H. Salinger,
Maria Palmisano,
Amy J. Sehnert,
Neelima Thanneer,
Hyunmoon Back,
Julie D. Seroogy,
Daniel D. Gretler,
Amit Roy,
Vidya Perera
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-02T12:00:00-07:00
DOI: 10.1002/psp4.13138
- Development of a physiologically based pharmacokinetic model of
fostemsavir and its pivotal application to support dosing in pregnancy
Authors:
Farzaneh Salem; Dung Nguyen,
Mark Bush,
Katy P. Moore,
Jennypher Mudunuru,
Konstantinos Stamatopoulos,
Nilay Thakkar,
Kunal S. Taskar
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2024-05-01T04:04:23-07:00
DOI: 10.1002/psp4.13156
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