Cargando…

Quantitative Systems Pharmacology: A Regulatory Perspective on Translation

Detalles Bibliográficos
Autor principal:	Zineh, Issam
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Perspectives
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618141/ https://www.ncbi.nlm.nih.gov/pubmed/30924594 http://dx.doi.org/10.1002/psp4.12403

Ejemplares similares

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

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

A Quantitative Systems Pharmacology Perspective on the Importance of Parameter Identifiability
por: Sher, Anna, et al.
Publicado: (2022)

A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development
por: Bai, Jane P. F., et al.
Publicado: (2020)

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary
por: Jean, Daphney, et al.
Publicado: (2021)

Industrialization of Quantitative Systems Pharmacology
por: Topp, Brian, et al.
Publicado: (2019)

Systems and Clinical Pharmacology of COVID-19 Therapeutic Candidates: A Clinical and Translational Medicine Perspective
por: Perazzolo, Simone, et al.
Publicado: (2021)

Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
por: Sato, M, et al.
Publicado: (2017)

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

NIH Support for the Emergence of Quantitative and Systems Pharmacology
por: Rogers, M, et al.
Publicado: (2013)

Quantitative Systems Pharmacology: A Case for Disease Models
por: Musante, CJ, et al.
Publicado: (2016)

Quantitative Systems Pharmacology and Empirical Models: Friends or Foes?
por: Benson, Neil
Publicado: (2019)

Incorporating Placebo Response in Quantitative Systems Pharmacology Models
por: Wang, Evan B., et al.
Publicado: (2019)

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

Perspective on the State of Pharmacometrics and Systems Pharmacology Integration
por: Trame, Mirjam N., et al.
Publicado: (2018)

Methodologies for Quantitative Systems Pharmacology (QSP) Models: Design and Estimation
por: Ribba, B, et al.
Publicado: (2017)

Perspectives on training quantitative systems pharmacologists
por: Zhang, Tongli, et al.
Publicado: (2022)

A Flexible Approach for Context‐Dependent Assessment of Quantitative Systems Pharmacology Models
por: Ramanujan, Saroja, et al.
Publicado: (2019)

A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins
por: Kierzek, Andrzej M., et al.
Publicado: (2019)

Conceptual and organizational barriers to quantitative systems pharmacology modeling of pathophysiological systemic drug hypotheses
por: Gieschke, Ronald, et al.
Publicado: (2022)

FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?
por: Peterson, MC, et al.
Publicado: (2015)

Application of quantitative systems pharmacology to guide the optimal dosing of COVID‐19 vaccines
por: Giorgi, Mario, et al.
Publicado: (2021)

A quantitative systems pharmacology approach to support mRNA vaccine development and optimization
por: Selvaggio, Gianluca, et al.
Publicado: (2021)

Potential Issues With Virtual Populations When Applied to Nonlinear Quantitative Systems Pharmacology Models
por: Duffull, Stephen, et al.
Publicado: (2020)

Quantitative Translation in Immuno‐Oncology Research and Development
por: Bottino, Dean, et al.
Publicado: (2020)

Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform
por: Franssen, Linnea C., et al.
Publicado: (2022)

QIN Benchmarks for Clinical Translation of Quantitative Imaging Tools
por: Farahani, Keyvan, et al.
Publicado: (2019)

Pharmacometrics, Physiologically Based Pharmacokinetics, Quantitative Systems Pharmacology—What's Next?—Joining Mechanistic and Epidemiological Approaches
por: Schmidt, Stephan, et al.
Publicado: (2019)

Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges
por: Musuamba, Flora T., et al.
Publicado: (2020)

Model‐informed target identification and validation through combining quantitative systems pharmacology with network‐based analysis
por: Chelliah, Vijayalakshmi, et al.
Publicado: (2022)

A human translational model based on neuroplasticity for pharmacological agents potentially effective in Treatment-Resistant Depression: focus on dopaminergic system
por: Collo, Ginetta, et al.
Publicado: (2019)

Single-cell RNA-sequencing and subcellular spatial transcriptomics facilitate the translation of liver microphysiological systems for regulatory application
por: Li, Dan, et al.
Publicado: (2023)

Heart Failure Pharmacological Management: Gaps and Current Perspectives
por: Severino, Paolo, et al.
Publicado: (2023)

A translational perspective towards clinical AI fairness
por: Liu, Mingxuan, et al.
Publicado: (2023)

Perspectives on an alternative career path in regulatory science
por: Fields, F. Owen
Publicado: (2013)

Regulatory Status of Cannabidiol in the United States: A Perspective
por: Corroon, Jamie, et al.
Publicado: (2018)

GPS for QSP: A Summary of the ACoP6 Symposium on Quantitative Systems Pharmacology and a Stage for Near‐Term Efforts in the Field
por: Musante, CJ, et al.
Publicado: (2016)

Critical need for pharmacologic treatment options in NAFLD: A pediatric perspective
por: Friesen, Chance S., et al.
Publicado: (2021)

Perspectives on statistical strategies for the regulatory biomarker qualification process
por: Hendrix, Suzanne B, et al.
Publicado: (2021)

A regulatory perspective on recombinant collagen-based medical devices
por: Liu, Wenbo, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_1dgcigih4347k9a0u4t661d826