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 …

Applications of advanced natural language processing for clinical pharmacology

JC Hsu, M Wu, C Kim, B Vora, YT Lien… - Clinical …, 2024 - Wiley Online Library
Natural language processing (NLP) is a branch of artificial intelligence, which combines
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 …

[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 …

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 …

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 …

Pharmacokinetics of Inhaled Medications–What Do We Know About Biological Macromolecules?

AH Lim, J Zhao, NA Rahim, J Zhao, H Liu… - Respiratory Delivery of …, 2024 - Springer
Over the last decades, biological macromolecules have attracted growing attention and
have become an important therapeutic modality. Biological macromolecules are peptide …