Research map: Regulatory Case Studies Encountered by Project Toxicologists in Drug Development

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  1. Emerging Issues in AAV-Mediated In Vivo Gene Therapy · Pasqualina Colella · 2017 · 893 citations · Cited by this paper
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  7. Development challenges associated with rAAV-based gene therapies · Michael W. Bolt · 2021 · 45 citations · Cited by this paper
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  11. Dorsal root ganglion toxicity after AAV intra-CSF delivery of a RNAi expression construct into non-human primates and mice · Zachary C. E. Hawley · 2024 · 21 citations · Cited by this paper
  12. Subchronic Toxicity and Teratogenicity Studies of Mycoprotein From Fusarium compactum MM-135 in Rats · 2026 · Related
  13. Neutralizing Antibodies: Role in Immune Response and Viral Vector Based Gene Therapy · Tatiana S. Tsaregorodtseva · 2025 · 16 citations · Cited by this paper
  14. Pair-Feeding Differentiates Feed-Dependent and Pharmacodynamic Effects of Telmisartan in Wistar Rats · 2026 · Related
  15. Scientific and Regulatory Policy Committee Points to Consider: Sampling, Processing, Evaluation, Interpretation, and Reporting of Test Article-Related Ganglion Pathology for Nonclinical Toxicity Studies · Bindu M. Bennet · 2023 · 14 citations · Cited by this paper
  16. Differential Activation of Peroxisome Proliferator-Activated Receptor Alpha by Per- and Polyfluoroalkyl Substances · 2025 · Related
  17. Neutralizing the Neutralizers in AAV Gene Therapy · Roland W. Herzog · 2020 · 10 citations · Cited by this paper
  18. Safety Assessment of Starch Phosphates as Used in Cosmetics · 2026 · Related
  19. Nonclinical toxicity study duration in AAV gene therapy development: Evidence from industry survey supports adequacy of short-term assessments · Basel T. Assaf · 2025 · 3 citations · Cited by this paper
  20. Key considerations for dose selection in first-in-human studies of cell and gene therapy products · Misaki Naota · 2025 · 3 citations · Cited by this paper
  21. Species barriers in AAV tropism: mechanisms, models, and emerging solutions for clinical translation · Xinyuan Xu · 2026 · 1 citation · Cited by this paper

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