Model‐Informed Approaches and Innovative Clinical Trial Design for Adeno‐Associated Viral Vector‐Based Gene Therapy Product Development: A White Paper
A Mitra, MA Ahmed, R Krishna, K Sun… - Clinical …, 2023 - Wiley Online Library
The promise of viral vector‐based gene therapy (GT) as a transformative paradigm for
treating severely debilitating and life‐threatening diseases is slowly coming to fruition with …
treating severely debilitating and life‐threatening diseases is slowly coming to fruition with …
Applications of advanced natural language processing for clinical pharmacology
Natural language processing (NLP) is a branch of artificial intelligence, which combines
computational linguistics, machine learning, and deep learning models to process human …
computational linguistics, machine learning, and deep learning models to process human …
[HTML][HTML] Model informed drug development: HSK21542 PBPK model supporting dose decisions in specific populations
M Zhang, Z Lei, X Yao, L Zhang, P Yan, N Wu… - European Journal of …, 2024 - Elsevier
HKS21542, a highly selective activator of peripheral kappa opioid receptor agonists, plays a
critical role in antinociception and itch inhibition during clinical development. Due to its …
critical role in antinociception and itch inhibition during clinical development. Due to its …
[HTML][HTML] Model-informed drug development and precision dosing in clinical pharmacology practice
K Hu, M Fu, X Huang, S He, Z Jiao… - Frontiers in …, 2023 - frontiersin.org
Model-informed drug development (MIDD) refers to the integration and quantitative study of
physiological, pharmacological, and disease process information using modeling and …
physiological, pharmacological, and disease process information using modeling and …
Application and Quality of Model‐Based Meta‐Analysis in Pharmaceutical Research: A Systematic Cross‐Sectional Analysis and Practical Considerations
Z Yang, H He, R Wang, D Liu, G Li… - Clinical Pharmacology & …, 2024 - Wiley Online Library
Model‐based meta‐analysis (MBMA) can be used in assisting drug development and
optimizing treatment in clinical practice, potentially reducing costs and accelerating drug …
optimizing treatment in clinical practice, potentially reducing costs and accelerating drug …
Physiologically-based pharmacokinetic modeling for pharmaceuticals—institute, industry and agencies perspective
AS Lale, MS Sanghavi, AK Saini - Advances in Drug Delivery …, 2024 - iopscience.iop.org
The chapter emphasizes the importance of a well-constructed physiologically-based
pharmacokinetic model in drug development to enhance mechanistic understanding of …
pharmacokinetic model in drug development to enhance mechanistic understanding of …
Pharmacokinetics of Inhaled Medications–What Do We Know About Biological Macromolecules?
Over the last decades, biological macromolecules have attracted growing attention and
have become an important therapeutic modality. Biological macromolecules are peptide …
have become an important therapeutic modality. Biological macromolecules are peptide …