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- Issue Information
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Volume 12, Issue 5, Page 545-548, May 2023.
PubDate: 2023-05-18T10:59:05-07:00
DOI: 10.1002/psp4.12820
Issue No: Vol. 12, No. 5 (2023)
- Development of a population pharmacokinetic model to characterize the
pharmacokinetics of intrathecally administered tominersen in cerebrospinal
fluid and plasma
Authors:
Yumi Yamamoto; Patricia Sanwald Ducray,
Marcus Björnsson,
Kevin Smart,
Paul Grimsey,
Suresh Vatakuti,
Agnes Portron,
Benoit Massonnet,
Daniel A. Norris,
Hanna E. Silber Baumann
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-05-23T10:48:34-07:00
DOI: 10.1002/psp4.13001
- Population pharmacokinetic analysis of sparsentan in healthy volunteers
and patients with focal segmental glomerulosclerosis
Authors:
Russell Wada; Huub Jan Kleijn,
Lu Zhang,
Shang‐Chiung Chen
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-05-23T10:06:08-07:00
DOI: 10.1002/psp4.12996
- Leveraging mathematical modeling to analyze nonadherence for hydroxyurea
therapy in sickle cell disease
Authors:
Akancha Pandey; Rubesh Raja,
Jeremie H. Estepp,
Doraiswami Ramkrishna
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-05-16T10:41:03-07:00
DOI: 10.1002/psp4.12945
- Physiologically Based Pharmacokinetic Modeling of Levetiracetam to Predict
the Exposure in Hepatic and Renal Impairment and Elderly Populations
Authors:
Chaozhuang Shen; Wenxin Shao,
Wenhui Wang,
Hua Sun,
Xiaohu Wang,
Kuo Geng,
Xingwen Wang,
Haitang Xie
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-05-11T10:29:27-07:00
DOI: 10.1002/psp4.12971
- A population pharmacokinetic and pharmacokinetic‐pharmacodynamic
analysis of vupanorsen from phase I and phase II studies
Authors:
Jae Eun Ahn; Steven G. Terra,
Jing Liu
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-05-11T09:23:30-07:00
DOI: 10.1002/psp4.12969
- Physiologically Based Pharmacokinetic Modeling of Quinidine to Establish a
CYP3A4, P‐gp and CYP2D6 Drug‐Drug‐Gene Interaction Network
Authors:
Denise Feick; Simeon Rüdesheim,
Fatima Zahra Marok,
Dominik Selzer,
Helena Leonie Hanae Loer,
Donato Teutonico,
Sebastian Frechen,
Maaike van der Lee,
Dirk Jan A. R. Moes,
Jesse J. Swen,
Matthias Schwab,
Thorsten Lehr
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-05-11T03:31:36-07:00
DOI: 10.1002/psp4.12981
- A multistate modeling and simulation framework to learn dose–response of
oncology drugs: Application to bintrafusp alfa in non‐small cell lung
cancer
Authors:
Han Liu; Ana‐Marija Milenković‐Grišić,
Sreenath M. Krishnan,
Siv Jönsson,
Lena E. Friberg,
Pascal Girard,
Karthik Venkatakrishnan,
Yulia Vugmeyster,
Akash Khandelwal,
Mats O. Karlsson
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-05-11T02:34:39-07:00
DOI: 10.1002/psp4.12976
- Population Pharmacokinetic Analysis of the P2X3‐Receptor Antagonist
Gefapixant
Authors:
Akshita Chawla; Anna Largajolli,
Azher Hussain,
Huub Kleijn,
Sihem Ait‐Oudhia,
Judith Anton,
Hari Ananthula,
Jesse Nussbaum,
Carmen La Rosa,
Ferdous Gheyas
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-05-05T11:31:55-07:00
DOI: 10.1002/psp4.12978
- QSP Designer: Quantitative systems pharmacology modeling with modular
biological process map notation and multiple language code generation
Authors:
Richard J. Matthews; David Hollinshead,
Daniel Morrison,
Piet H. Graaf,
Andrzej M. Kierzek
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-05-04T10:43:06-07:00
DOI: 10.1002/psp4.12972
- Requirements, expectations, challenges and opportunities associated with
training the next generation of pharmacometricians
Authors:
Stephan Schmidt; Valvanera Vozmediano,
Rodrigo Cristofoletti,
Sarah Kim,
Zhoumeng Lin,
Natalia Moraes,
Francine Azeredo,
Brian Cicali,
Hans Leuenberger,
Joshua D. Brown,
Jin Y. Jin,
Cynthia J. Musante,
Stacey Tannenbaum,
Yaning Wang
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-05-02T04:43:59-07:00
DOI: 10.1002/psp4.12970
- Combination of Antidepressants and Antipsychotics as A Novel Treatment
Option for Psychosis in Alzheimer's Disease
Authors:
Peihao Fan; Lang Zeng,
Ying Ding,
Julia Kofler,
Jonathan Silverstein,
Joshua Krivinko,
Robert A. Sweet,
Lirong Wang
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-05-01T11:00:52-07:00
DOI: 10.1002/psp4.12979
- Evaluation of model‐based bioequivalence approach for single sample
pharmacokinetic studies
Authors:
Coralie Tardivon; Florence Loingeville,
Mark Donnelly,
Kairui Feng,
Wanjie Sun,
Guoying Sun,
Stella Grosser,
Liang Zhao,
Lanyan Fang,
France Mentré,
Julie Bertrand
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-04-27T11:46:13-07:00
DOI: 10.1002/psp4.12960
- Advances in quantitative methods and modeling for complex generic drugs
and opportunities to hybridize learnings between innovator and generic
drug developers
Authors:
Priya Jayachandran
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-04-27T10:24:38-07:00
DOI: 10.1002/psp4.12968
- Model‐based approach to identify predictors of paclitaxel‐induced
myelosuppression in “real‐world” administration
Authors:
Ahmed M. Salem; Erik Dvergsten,
Sanja Karovic,
Michael L. Maitland,
Mathangi Gopalakrishnan
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-04-26T10:40:31-07:00
DOI: 10.1002/psp4.12963
- Modeling Alzheimer's Disease Progression Utilizing Clinical Trial and ADNI
Data to Predict Longitudinal Trajectory of CDR‐SB
Authors:
Samira Jamalian; Michael Dolton,
Pascal Chanu,
Vidya Ramakrishnan,
Yesenia Franco,
Kristin Wildsmith,
Paul Manser,
Edmond Teng,
Jin Y. Jin,
Angelica Quartino,
Joy C. Hsu,
Alzheimer's Disease Neuroimaging Initiative
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-04-26T10:31:22-07:00
DOI: 10.1002/psp4.12974
- Physiologically based pharmacokinetic pharmacodynamic parent‐metabolite
model of edoxaban to predict drug‐drug‐disease interactions: M4
contribution
Authors:
Ruijuan Xu; Wenyuan Liu,
Weihong Ge,
Hua He,
Qing Jiang
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-04-26T10:28:24-07:00
DOI: 10.1002/psp4.12977
- Sabatolimab (MBG453) Model Informed Drug Development for Dose Selection in
Patients with Myelodysplastic Syndrome/Acute Myeloid Leukemia and Solid
Tumors
Authors:
Siyan Xu; Na Zhang,
Mikael L. Rinne,
Haiying Sun,
Andrew M. Stein
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-04-25T10:34:26-07:00
DOI: 10.1002/psp4.12962
- Disease Progression Joint Model Predicts Time to Type 1 Diabetes Onset:
Optimizing Future Type 1 Diabetes Prevention Studies
Authors:
Juan Francisco Morales; Rhoda Muse,
Jagdeep Podichetty,
Jackson Burton,
Sarah David,
Patrick Lang,
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, Accepted Article.
PubDate: 2023-04-25T10:30:02-07:00
DOI: 10.1002/psp4.12973
- Development of a PBPK model to quantitatively understand absorption and
disposition mechanism and support future clinical trials for PB‐201
Authors:
Miao Zhang; Zihan Lei,
Ziheng Yu,
Xueting Yao,
Haiyan Li,
Min Xu,
Dongyang Liu
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-04-20T02:12:32-07:00
DOI: 10.1002/psp4.12964
- Population PK/PD model of tacrolimus for exploring the relationship
between accumulated exposure and quantitative scores in myasthenia gravis
patients
Authors:
Di Chen; Qingyu Yao,
Wenjun Chen,
Jian Yin,
Shifang Hou,
Xiaoxin Tian,
Ming Zhao,
Hua Zhang,
Liping Yang,
Tianyan Zhou,
Pengfei Jin
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-04-14T10:40:24-07:00
DOI: 10.1002/psp4.12966
- Synthetic Model Combination: A new machine learning method for
pharmacometric model ensembling
Authors:
Alexander Chan; Richard Peck,
Megan Gibbs,
Mihaela van der Schaar
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-04-12T12:14:29-07:00
DOI: 10.1002/psp4.12965
- Model‐informed pediatric dose selection of marzeptacog alfa (activated):
an exposure matching strategy
Authors:
Alan Faraj; Rob C. van Wijk,
Linda Neuman,
Shraddha Desai,
Grant E. Blouse,
Tom Knudsen,
Ulrika S. H. Simonsson
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-04-12T02:44:33-07:00
DOI: 10.1002/psp4.12967
- Biased computation of probability of target attainment for antimicrobial
drugs
Authors:
Pierre‐Louis Toutain; Peggy Gandia,
Ludovic Pelligand,
Aude A. Ferran,
Peter Lees,
Alain Bousquet‐Mélou,
Didier Concordet
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-04-06T10:40:23-07:00
DOI: 10.1002/psp4.12929
- Population pharmacokinetics of tenofovir given as either tenofovir
disoproxil fumarate or tenofovir alafenamide in an African population
Authors:
Aida N. Kawuma; Roeland E. Wasmann,
Phumla Sinxadi,
Simiso M. Sokhela,
Nomathemba Chandiwana,
Willem D. F. Venter,
Lubbe Wiesner,
Gary Maartens,
Paolo Denti
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-04-04T12:41:02-07:00
DOI: 10.1002/psp4.12955
- A decision support system based on artificial intelligence and systems
biology for the simulation of pancreatic cancer patient status
Authors:
Valentin Junet; Pedro Matos‐Filipe,
Juan Manuel García‐Illarramendi,
Esther Ramírez,
Baldo Oliva,
Judith Farrés,
Xavier Daura,
José Manuel Mas,
Rafael Morales
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-31T11:58:19-07:00
DOI: 10.1002/psp4.12961
- Model‐based simulation to support the approval of isatuximab alone or
with dexamethasone for the treatment of relapsed/refractory multiple
myeloma in Japanese patients
Authors:
Hoai‐Thu Thai; Kimiko Koiwai,
Yoshihisa Shitara,
Hirotaka Kazama,
Jean‐Baptiste Fau,
Dorothée Semiond,
Christine Veyrat‐Follet
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-31T11:44:24-07:00
DOI: 10.1002/psp4.12947
- Prediction of gastric pH‐mediated drug exposure using
physiologically‐based pharmacokinetic modeling: A case study of
itraconazole
Authors:
Eunsol Yang; Kyung‐Sang Yu,
SeungHwan Lee
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-26T09:10:28-07:00
DOI: 10.1002/psp4.12959
- Relationship between factor VIII levels and bleeding for
rFVIII‐SingleChain in severe hemophilia A: A repeated time‐to‐event
analysis
Authors:
Laura H. Bukkems; Siv Jönsson,
Marjon H. Cnossen,
Mats O. Karlsson,
Ron A. A. Mathôt,
the OPTI‐CLOT studies the SYMPHONY consortium
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-25T01:01:21-07:00
DOI: 10.1002/psp4.12938
- Barriers to global pharmacometrics: educational challenges and
opportunities across the globe
Authors:
Robin Michelet; Linda B. S. Aulin,
Jens M. Borghardt,
Teresa Dalla Costa,
Paolo Denti,
Manuel Ibarra,
Guangda Ma,
Bernd Meibohm,
Goonaseelan (Colin) Pillai,
Stephan Schmidt,
Stefanie Hennig,
Charlotte Kloft
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-24T12:44:00-07:00
DOI: 10.1002/psp4.12940
- Bounded integer model‐based analysis of psoriasis area and severity
index in patients with moderate‐to‐severe plaque psoriasis receiving
BI 730357
Authors:
Qing Xi Ooi; Anders Kristoffersson,
Julia Korell,
Mary Flack,
Elodie Plan,
Benjamin Weber
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-03-15T12:44:01-07:00
DOI: 10.1002/psp4.12948
- Population pharmacokinetics and exposure‐response analysis of a single
dose of sotrovimab in the early treatment of patients with mild to
moderate COVID‐19
Authors:
Jennifer E. Sager; Asma El‐Zailik,
Julie Passarell,
Stefan Roepcke,
Xiaobin Li,
Melissa Aldinger,
Ahmed Nader,
Andrew Skingsley,
Elizabeth L. Alexander,
Wendy W. Yeh,
Erik Mogalian,
Chad Garner,
Amanda Peppercorn,
Adrienne E. Shapiro,
Maribel Reyes
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-03-15T10:44:56-07:00
DOI: 10.1002/psp4.12958
- Minimal physiologically‐based hybrid model of pharmacokinetics in
pregnant women: Application to antenatal corticosteroids
Authors:
Wojciech Krzyzanski; Mark A. Milad,
Alan H. Jobe,
William J. Jusko
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-14T12:10:11-07:00
DOI: 10.1002/psp4.12899
- Interplay among malnutrition, chemoprevention, and the risk of malaria in
young Ugandan children: Longitudinal pharmacodynamic and growth analysis
Authors:
Ali Mohamed Ali; Erika Wallender,
Emma Hughes,
Grant Dorsey,
Radojka M. Savic
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-14T10:53:33-07:00
DOI: 10.1002/psp4.12892
- PK/PD modeling and simulation of the in vitro activity of the combinations
of isavuconazole with echinocandins against Candida auris
Authors:
Unai Caballero; Elena Eraso,
Guillermo Quindós,
Valvanera Vozmediano,
Stephan Schmidt,
Nerea Jauregizar
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-13T10:39:00-07:00
DOI: 10.1002/psp4.12949
- A mechanistic modeling platform of SGLT2 inhibition: Implications for type
1 diabetes
Authors:
Victor Sokolov; Tatiana Yakovleva,
Leonid Stolbov,
Robert C. Penland,
David Boulton,
Joanna Parkinson,
Weifeng Tang
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-03-13T04:49:50-07:00
DOI: 10.1002/psp4.12956
- PK/PD modeling to characterize placebo and treatment effect of omalizumab
for chronic spontaneous urticaria
Authors:
Elise Oh; Russ Wada,
Kha Le,
Yanan Zheng,
Jin Jin,
Victor Poon,
Kit Wong,
Ryan Owen,
Kenta Yoshida
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-03-10T03:55:56-08:00
DOI: 10.1002/psp4.12953
- Pharmacokinetic‐Pharmacodynamic Model of Urinary δ‐Aminolevulinic
Acid Reduction After Givosiran Treatment in Patients with Acute Hepatic
Porphyria
Authors:
Jongtae Lee; Megan Melch,
Gabriel J. Robbie
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-03-08T04:24:43-08:00
DOI: 10.1002/psp4.12957
- Physiologically Based Pharmacokinetic Modeling for Development and
Applications of a Virtual Celiac Disease Population using Felodipine as a
model drug
Authors:
Farzaneh Salem; Ali Nimavardi,
Jennypher Mudunuru,
Debra Tompson,
Jackie Bloomer,
David B. Turner,
Kunal S. Taskar
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-28T11:29:03-08:00
DOI: 10.1002/psp4.12954
- Mechanistic Modeling of Ophthalmic, Nasal, Injectable, and Implant Generic
Drug Products: A Workshop Summary Report
Authors:
Ming‐Liang Tan; Sajeev Chandran,
Rebeka Jereb,
Khondoker Alam,
Robert Bies,
Darby Kozak,
Ross Walenga,
Maxime Le Merdy,
Andrew Babiskin
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-27T10:49:25-08:00
DOI: 10.1002/psp4.12952
- Genetic and Non‐genetic Factors Influencing Efavirenz Population
Pharmacokinetics Among HIV‐infected Children in Ethiopia
Authors:
Adugna Chala; Eliford Ngaimisi Kitabi,
Jemal Hussien Ahmed,
Birkneh Tilahun Tadesse,
Tolossa Eticha Chaka,
Eyasu Makonnen,
Eleni Aklillu
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-24T11:38:25-08:00
DOI: 10.1002/psp4.12951
- PBPK modeling of ivermectin ‐ considerations for the purpose of
developing alternative routes to optimize its safety profile
Authors:
Karen Rowland Yeo; David Wesche
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-24T11:38:15-08:00
DOI: 10.1002/psp4.12950
- Physiologically Based Pharmacokinetic Modeling of Tacrolimus for
Food‐Drug and CYP3A Drug‐Drug‐Gene Interaction Predictions
Authors:
Helena Leonie Hanae Loer; Denise Feick,
Simeon Rüdesheim,
Dominik Selzer,
Matthias Schwab,
Donato Teutonico,
Sebastian Frechen,
Maaike van der Lee,
Dirk Jan A. R. Moes,
Jesse J. Swen,
Thorsten Lehr
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-19T10:49:19-08:00
DOI: 10.1002/psp4.12946
- Characterizing the exposure–response relationship of idecabtagene
vicleucel in patients with relapsed/refractory multiple myeloma
Authors:
Jamie N. Connarn; Han Witjes,
Marielle van Zutphen‐van Geffen,
Rik Greef,
Timothy B. Campbell,
Kristen Hege,
Simon Zhou,
Manisha Lamba
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-15T11:39:59-08:00
DOI: 10.1002/psp4.12922
- Model‐based prediction of effective target exposure for MEN1611 in
combination with trastuzumab in HER2‐positive advanced or metastatic
breast cancer patients
Authors:
Elena M. Tosca; Elisa Borella,
Chiara Piana,
Salim Bouchene,
Giuseppe Merlino,
Alessio Fiascarelli,
Paolo Mazzei,
Paolo Magni
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-15T10:39:48-08:00
DOI: 10.1002/psp4.12910
- Population pharmacokinetic modeling and simulation of maribavir to support
dose selection and regulatory approval in adolescents with
post‐transplant refractory cytomegalovirus
Authors:
Kefeng Sun; Siobhan Hayes,
Colm Farrell,
Ivy H. Song
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-14T11:54:22-08:00
DOI: 10.1002/psp4.12943
- A prognostic baseline blood biomarker and tumor growth kinetics integrated
model in paclitaxel/platinum treated advanced non‐small cell lung cancer
patients
Authors:
Francis Williams Ojara; Andrea Henrich,
Nicolas Frances,
Yomna M. Nassar,
Wilhelm Huisinga,
Niklas Hartung,
Kimberly Geiger,
Stefan Holdenrieder,
Markus Joerger,
Charlotte Kloft
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-13T09:13:46-08:00
DOI: 10.1002/psp4.12937
- Population pharmacokinetic dosimetry model using imaging data to assess
variability in pharmacokinetics of 177Lu‐PSMA‐617 in prostate cancer
patients
Authors:
Hinke Siebinga; Bastiaan M. Privé,
Steffie M. B. Peters,
James Nagarajah,
Thomas P. C. Dorlo,
Alwin D. R. Huitema,
Berlinda J. Wit‐van der Veen,
Jeroen J. M. A. Hendrikx
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-09T10:40:44-08:00
DOI: 10.1002/psp4.12914
- Mechanistically modeling peripheral cytokine dynamics following bispecific
dosing in solid tumors
Authors:
Jared Weddell
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-09T02:55:14-08:00
DOI: 10.1002/psp4.12928
- Increasing impact of quantitative methods and modeling in establishment of
bioequivalence and characterization of drug delivery
Authors:
Miyoung Yoon; Andrew Babiskin,
Meng Hu,
Fang Wu,
Sam G. Raney,
Lanyan Fang,
Liang Zhao
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-09T02:15:05-08:00
DOI: 10.1002/psp4.12930
- Establishing the suitability of model‐integrated evidence to demonstrate
bioequivalence for long‐acting injectable and implantable drug products:
Summary of workshop
Authors:
Yuqing Gong; Peijue Zhang,
Miyoung Yoon,
Hao Zhu,
Ameya Kohojkar,
Andrew C. Hooker,
Murray P. Ducharme,
Jogarao Gobburu,
Géraldine Cellière,
Parmesh Gajjar,
Bing V. Li,
Raja Velagapudi,
Yu Chung Tsang,
Anna Schwendeman,
James Polli,
Lanyan Fang,
Robert Lionberger,
Liang Zhao
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-09T01:58:35-08:00
DOI: 10.1002/psp4.12931
- The quest for balance between capturing data and model complexity: a
quantitative clinical pharmacology approach applied to monoclonal
antibodies
Authors:
Michelle A. Pressly; Lambertus A. Peletier,
Songmao Zheng,
Vishnu D. Sharma,
Yi Ting (Kayla) Lien,
Weirong Wang,
Honghui Zhou,
Stephan Schmidt
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-08T03:23:27-08:00
DOI: 10.1002/psp4.12927
- Regulatory utility of mechanistic modeling to support alternative
bioequivalence approaches: A workshop overview
Authors:
Andrew Babiskin; Fang Wu,
Youssef Mousa,
Ming‐Liang Tan,
Eleftheria Tsakalozou,
Ross L. Walenga,
Miyoung Yoon,
Sam G. Raney,
James E. Polli,
Anna Schwendeman,
Vishalakshi Krishnan,
Lanyan Fang,
Liang Zhao
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-02-05T08:04:42-08:00
DOI: 10.1002/psp4.12920
- Cell‐level systems biology model to study inflammatory bowel diseases
and their treatment options
Authors:
Sabine Stübler; Charlotte Kloft,
Wilhelm Huisinga
Abstract: CPT: Pharmacometrics &Systems Pharmacology, Accepted Article.
PubDate: 2023-02-01T11:54:28-08:00
DOI: 10.1002/psp4.12932
- Model‐based meta‐analysis of non‐small cell lung cancer with
standard of care PD‐1 inhibitors and chemotherapy for early development
decision making
Authors:
David C. Turner; Russ Wada,
Helen Zhou,
Xiaowei Wang,
Rik Greef,
Chandni Valiathan,
Lindsey Zhang,
Nancy Zhang,
Mita Kuchimanchi,
Tai‐Tsang Chen,
Marc Ballas,
Sandra A. G. Visser
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-01-31T03:33:23-08:00
DOI: 10.1002/psp4.12917
- Regulatory utility of physiologically based pharmacokinetic modeling for
assessing food impact in bioequivalence studies: A workshop summary report
Authors:
Abdullah Al Shoyaib; Arian Emami Riedmaier,
Anita Kumar,
Partha Roy,
Neil John Parrott,
Lanyan Fang,
Nilufer Tampal,
Yuching Yang,
Rebeka Jereb,
Liang Zhao,
Fang Wu
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-01-16T09:07:56-08:00
DOI: 10.1002/psp4.12913
- Using mechanistic models to support development of complex generic drug
products: European Medicines Agency perspective
Authors:
Efthymios Manolis; Alfredo García‐Arieta,
Anders Lindahl,
Evangelos Kotzagiorgis,
Jobst Limberg,
Øyvind Holte,
Paulo Paixao,
Carolien Versantvoort,
Flora Musuamba Tshinanu,
Kevin Blake,
Michiel Van Den Heuvel
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-01-11T02:17:59-08:00
DOI: 10.1002/psp4.12906
- Regulatory utility of physiologically‐based pharmacokinetic modeling to
support alternative bioequivalence approaches and risk assessment: A
workshop summary report
Authors:
Fang Wu; Youssef Mousa,
Kimberly Raines,
Chris Bode,
Yu Chung Tsang,
Rodrigo Cristofoletti,
Hongling Zhang,
Tycho Heimbach,
Lanyan Fang,
Filippos Kesisoglou,
Amitava Mitra,
James Polli,
Myong‐Jin Kim,
Jianghong Fan,
Banu S. Zolnik,
Duxin Sun,
Yi Zhang,
Liang Zhao
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2023-01-04T04:08:28-08:00
DOI: 10.1002/psp4.12907
- Mechanistic modeling of generic orally inhaled drug products: A workshop
summary report
Authors:
Ross L. Walenga; Clare Butler,
Brent A. Craven,
P. Worth Longest,
Raja Mohamed,
Bryan Newman,
Bo Olsson,
Günther Hochhaus,
Bing V. Li,
Markham C. Luke,
Liang Zhao,
Andrzej Przekwas,
Robert Lionberger
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2022-12-20T09:59:57-08:00
DOI: 10.1002/psp4.12889
- Mechanistic modeling of drug products applied to the skin: A workshop
summary report
Authors:
Eleftheria Tsakalozou; Khondoker Alam,
Priyanka Ghosh,
Jessica Spires,
Sebastian Polak,
Lanyan Fang,
Srinivasa Sammeta,
Ping Zhao,
Sumit Arora,
Sam G. Raney
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2022-12-01T07:59:07-08:00
DOI: 10.1002/psp4.12893
- PK/PD model‐informed dose selection for oncology phase I expansion: Case
study based on PF‐06939999, a PRMT5 inhibitor
Authors:
Cen Guo; Kai H. Liao,
Meng Li,
I‐Ming Wang,
Naveed Shaik,
Donghua Yin
Abstract: CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
PubDate: 2022-11-16T11:39:35-08:00
DOI: 10.1002/psp4.12882
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