Copertina

Reflections on Model‐Informed Drug Development

Fuente: Wiley Open Access

Salvato in:

Dettagli Bibliografici
Autori principali:	Lawrence J. Lesko, Piet H. van der Graaf
Natura:	Artículo Open Access
Pubblicazione:	Wiley 2024
Soggetti:	Clinical Pharmacology & Therapeutics
Accesso online:	Acceder al recurso
Tags:	Aggiungi Tag Nessun Tag, puoi essere il primo ad aggiungerne!!

Documenti analoghi

History and Evolution of Innovations in Clinical Pharmacology
di: Lawrence J. Lesko, et al.
Pubblicazione: (2025)

Weaning off ThoroughQTStudies
di: Mai Mehanna, et al.
Pubblicazione: (2024)

Interchanging Biosimilars Using Proteomics
di: Piet H. van der Graaf, et al.
Pubblicazione: (2025)

Progress in Clinical Pharmacology in China: An Ongoing Evolution
di: Liang Zhao, et al.
Pubblicazione: (2025)

Best Practices for Pharmacokinetic Studies of New Chemical Entities
di: Ya‐Feng Wen, et al.
Pubblicazione: (2024)

Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine
di: Liang Zhao, et al.
Pubblicazione: (2024)

Innovations in Clinical Pharmacology: Shaping the Future of Evidence Generation in Research, Development, and Utilization of Medicines
di: Karthik Venkatakrishnan, et al.
Pubblicazione: (2025)

Artificial Intelligence/Machine Learning: The New Frontier of Clinical Pharmacology and Precision Medicine
di: Qi Liu, et al.
Pubblicazione: (2024)

Getting the Dosage Right: A Vital Role for Clinical Pharmacology in the Era of Precision Medicine
di: Iris K. Minichmayr, et al.
Pubblicazione: (2024)

Bridging the Gap: Integrating Quantitative Systems Pharmacology and Pharmacometrics in Drug Development
di: Georgi I. Kapitanov, et al.
Pubblicazione: (2025)

Model‐Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC : A QSP Model for Alpelisib and Tipifarnib Combination
di: Jaehee Shim, et al.
Pubblicazione: (2026)

Moving the Needle for Oncology Dose Optimization: A Call for Action
di: Karthik Venkatakrishnan, et al.
Pubblicazione: (2024)

Seasons of Growth: Reflections on the CPT Editor‐in‐Training Program
di: Matthijs W. van Hoogdalem, et al.
Pubblicazione: (2025)

Impact of Model‐Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost
di: Vaishali Sahasrabudhe, et al.
Pubblicazione: (2025)

New Horizons of Model Informed Drug Development in Rare Diseases Drug Development
di: Amitava Mitra, et al.
Pubblicazione: (2024)

The US Food and Drug Administration's Model‐Informed Drug Development Meeting Program: From Pilot to Pathway
di: Rajanikanth Madabushi, et al.
Pubblicazione: (2024)

Extended Model‐Informed Drug Development: Beyond Clinical Trials and Regulatory Approval
di: Mohamed A. Kamal, et al.
Pubblicazione: (2024)

Model‐Informed Drug Development Supports Full Approval of Ibuprofen Injection in Chinese Pediatric Patients With Fever or Pain
di: Qianxi Lou, et al.
Pubblicazione: (2025)

Innovations and Best Practices for Therapeutic Development in Pediatric Rare Diseases: A Model‐Informed Drug Development Perspective
di: Rajesh Krishna, et al.
Pubblicazione: (2025)

Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program
di: Gerald R. Galluppi, et al.
Pubblicazione: (2024)

From Classical PKPD to Model‐Informed Drug Development: Are “Digital Twins” a New Paradigm?
di: Brett E. Houk
Pubblicazione: (2026)

Quantitative Systems Pharmacology‐Based Digital Twins Approach Supplements Clinical Trial Data for Enzyme Replacement Therapies in Pompe Disease
di: Chanchala Kaddi, et al.
Pubblicazione: (2024)

A Comprehensive CYP2D6 Drug–Drug–Gene Interaction Network for Application in Precision Dosing and Drug Development
di: Simeon Rüdesheim, et al.
Pubblicazione: (2025)

Therapeutic Drug Monitoring of Oral Oncology Drugs: Finding the Right Nails
di: Niels A. D. Guchelaar, et al.
Pubblicazione: (2024)

Effects of GLPG3970 on Sulfasalazine and Methotrexate Pharmacokinetics in Healthy Adults: Two Open‐Label, Phase I, Drug–Drug Interaction Studies
di: Mariska van der Plas, et al.
Pubblicazione: (2024)

Model‐Informed Drug Development‐Based Bridging from Subcutaneous to Intravenous Secukinumab Dosing: Approval in Psoriatic Arthritis and Axial Spondyloarthritis
di: Thomas Dumortier, et al.
Pubblicazione: (2025)

Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug–Drug Interaction Study
di: Joseph Burnett, et al.
Pubblicazione: (2025)

Emerging Tools and Technologies for Microbiome‐Aware Drug Development
di: Henry J. Haiser, et al.
Pubblicazione: (2025)

Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective
di: Jie Chen, et al.
Pubblicazione: (2025)

Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial
di: Jules M. Janssen Daalen, et al.
Pubblicazione: (2024)

Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective
di: Jie Chen, et al.
Pubblicazione: (2025)

Drug Interactions Brewing
di: Matthijs W. van Hoogdalem, et al.
Pubblicazione: (2025)

Model‐Informed Drug Development‐Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with Active Psoriatic Arthritis, Active Ankylosing Spondylitis, and Active Non‐Radiographic Axial Spondyloarthritis
di: Dipak S. Pisal, et al.
Pubblicazione: (2024)

Advancing Pharmacoequity Globally: Reflections from the ASCPT Development, Regulatory, and Outcomes Network
di: Priya Jayachandran, et al.
Pubblicazione: (2026)

Quantitative Systems Pharmacology Models: Potential Tools for Advancing Drug Development for Rare Diseases
di: Susana Neves‐Zaph, et al.
Pubblicazione: (2024)

Quantitative Approaches to Accelerate MASH Drug Discovery and Development
di: Yasmeen Abouelhassan, et al.
Pubblicazione: (2025)

Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies
di: Mihoko Kobayashi, et al.
Pubblicazione: (2025)

Biomarkers of Drug‐Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development
di: Tanja S. Zabka, et al.
Pubblicazione: (2025)

Phenotypic Models of Drug–Drug‐Gene Interactions Mediated by Cytochrome Drug‐Metabolizing Enzymes
di: Roberto Viviani, et al.
Pubblicazione: (2024)

Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection
di: Allison M. Claas, et al.
Pubblicazione: (2024)