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Review Open access Sep 2026

Pharmaceutical Industry Perspectives on Exposure‐Response Confounding in Large Molecule Therapeutics: Results From an IQ Consortium Survey

Exposure‐response (ER) analyses assessing the efficacy of large molecule therapeutics are often susceptible to confounding, where associations between drug exposure and patient disease severity can obscure true ER signals and complicate dose selection. To better understand the pharmaceutical industry perspectives on th...

Engie Salama, M. Lamba, Sihem Ait-Oudhia et al. · 0 citations
Review Open access Aug 2026

Industry Perspective on Translational and Clinical Pharmacology Aspects of Viral-based Gene Therapies and Vaccines—Key Considerations and Learnings From Approved Products

Viral-based gene therapies and vaccines represent a rapidly evolving modality for treating a wide range of diseases. However, these novel modalities pose novel and complex challenges for translational PK/PD scientists and clinical pharmacologists during preclinical and clinical development. To support accelerated devel...

H. Mody, Jatin Narula, Prathap Nagaraja Shastri et al. · 0 citations

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