Cargando…

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

Detalles Bibliográficos
Autores principales:	Jean, Daphney, Naik, Kunal, Milligan, Lauren, Hall, Stephen, Mei Huang, Shiew, Isoherranen, Nina, Kuemmel, Colleen, Seo, Paul, Tegenge, Million A., Wang, Yaning, Yang, Yuching, Zhang, Xinyuan, Zhao, Liang, Zhao, Ping, Benjamin, Jessica, Bergman, Kimberly, Grillo, Joseph, Madabushi, Rajanikanth, Wu, Fang, Zhu, Hao, Zineh, Issam
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Perspectives
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592512/ https://www.ncbi.nlm.nih.gov/pubmed/34536337 http://dx.doi.org/10.1002/psp4.12706

Ejemplares similares

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation
por: Kuemmel, Colleen, et al.
Publicado: (2019)

A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development
por: Madabushi, Rajanikanth, et al.
Publicado: (2019)

Emerging Role of Organ‐on‐a‐Chip Technologies in Quantitative Clinical Pharmacology Evaluation
por: Isoherranen, Nina, et al.
Publicado: (2019)

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making
por: Madabushi, Rajanikanth, et al.
Publicado: (2022)

Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs
por: Schuck, Robert N., et al.
Publicado: (2019)

Considerations for Optimizing Dosing of Immunoglobulins Based on Pharmacokinetic Evidence
por: Mahmood, Iftekhar, et al.
Publicado: (2020)

Quantitative Systems Pharmacology: A Regulatory Perspective on Translation
por: Zineh, Issam
Publicado: (2019)

Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations
por: Zhang, Xinyuan, et al.
Publicado: (2021)

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration
por: Bai, Jane P. F., et al.
Publicado: (2021)

Dosing Considerations for Antibodies Against COVID-19
por: Tegenge, Million A., et al.
Publicado: (2020)

Opportunities and challenges for applying model‐informed drug development approaches to gene therapies
por: Belov, Artur, et al.
Publicado: (2021)

The clinical pharmacogeneticist: An emerging regulatory scientist at the US Food and Drug Administration
por: Zineh, Issam, et al.
Publicado: (2010)

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report
por: Al Shoyaib, Abdullah, et al.
Publicado: (2023)

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA
por: Hsieh, Julie, et al.
Publicado: (2022)

Advancing the science of patient input throughout the regulatory decision‐making process
por: Tegenge, Million A., et al.
Publicado: (2017)

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH
por: Zhu, Hao, et al.
Publicado: (2019)

Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective
por: Drozda, Katarzyna, et al.
Publicado: (2018)

Need for Representation of Pediatric Patients with Obesity in Clinical Trials
por: Samuels, Sherbet, et al.
Publicado: (2023)

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval
por: Strauss, David G., et al.
Publicado: (2022)

Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020
por: Abulwerdi, Gelareh A., et al.
Publicado: (2023)

Workshop Summary
por: LE MEUR, Jean-Yves
Publicado: (2015)

Summary of the Workshop
por: Myers, S, et al.
Publicado: (2011)

Workshop summary
por: Chao, A, et al.
Publicado: (1990)

Summary of the Workshop
por: Myers, S, et al.
Publicado: (2012)

Workshop summary
por: Burkhardt, H, et al.
Publicado: (2009)

FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis
por: Kasamon, Yvette L., et al.
Publicado: (2018)

Serum Monocyte Chemoattractant Protein-1 Concentrations Associate With Diabetes Status but Not Arterial Stiffness in Children With Type 1 Diabetes
por: Zineh, Issam, et al.
Publicado: (2009)

Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives
por: Marshall, Scott, et al.
Publicado: (2019)

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer
por: Shord, Stacy S., et al.
Publicado: (2023)

Summary of best evidence for prevention and control of pressure ulcer on support surfaces
por: Huang, Lijun, et al.
Publicado: (2023)

Workshop summary and closing
por: Hesse, Connie
Publicado: (2017)

Summary of workshop on automation
por: Tyrer, Harry W.
Publicado: (1981)

Concensus Summaries of Workshops
Publicado: (1983)

Summary of the Eilat workshop
por: Sciulli, F
Publicado: (1994)

Summary of the Padova workshop
por: Kifune, T
Publicado: (1995)

LHC workshop summary
por: Kalmus, George Ernest
Publicado: (1990)

Summary of the ILC workshop
por: Lilje, L
Publicado: (2004)

Workshop Summary and Outlook
por: Stone, S
Publicado: (2013)

Summary of the RPC Workshop
por: Guida, Roberto
Publicado: (2022)

Synthesis and Herbicidal Activity of Novel 1-(Diethoxy-phosphoryl)-3-(4-one-1H-1,2,3-triazol-1-yl)-propan-2-yl Carboxylic Esters
por: Jin, Yan, et al.
Publicado: (2015)

Cannot write session to /tmp/vufind_sessions/sess_974e4trlordfkn0p3cfhen0bal