Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies

An evaluation framework for new approach methodologies (NAMs) for human health safety assessment

Stanley T. Parish, Michael Aschner, Warren Casey et al. · Regulatory Toxicology and Pharmacology · 2020 · 194 citations · Full text

Pharmacy, Toxicology, Hazard Identification +15

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Amy M. Avila, Ilona Bebenek, Jessica A. Bonzo et al. · Regulatory Toxicology and Pharmacology · 2020 · 183 citations

Pharmacy, Toxicology, Analytical Toxicology +14

Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism, and accumulation

Andrés M. Rubiano, Amruta Indapurkar, Ryosuke Yokosawa et al. · Clinical and Translational Science · 2020 · 93 citations · Full text

Pharmacy, Pharmacology, Toxicology +17

Building a Roadmap to Biomarker Qualification: Challenges and Opportunities

Shashi Amur, Sarmistha Sanyal, Aloka Chakravarty et al. · Biomarkers in Medicine · 2015 · 54 citations

Pharmacy, Pharmaceutical Policy, Clinical Pharmacology +13

Co‐Culture of Human Primary Hepatocytes and Nonparenchymal Liver Cells in the Emulate® Liver‐Chip for the Study of Drug‐Induced Liver Injury

Qiang Shi, Ayesha Arefin, Lijun Ren et al. · Current Protocols · 2022 · 33 citations

Medicine, Cell Biology, Pharmacology +17