Madabushi, Rajanikanth

Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

Wang, Y., Zhu, H., Madabushi, R., Liu, Q., Huang, S., & Zineh, I. (2019) · Clinical Pharmacology & Therapeutics

Pharmaceutical studies and practicesStatistical Methods in Clinical Trials

Cited by 228

Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives

Marshall, S., Madabushi, R., Manolis, E., Krudys, K., Staab, A., Dykstra, K., & Visser, S. A. G. (2019) · CPT: Pharmacometrics & Systems Pharmacology

Pharmaceutical studies and practicesStatistical Methods in Clinical Trials

Cited by 138

The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact

Madabushi, R., Benjamin, J. M., Grewal, R., Pacanowski, M. A., Strauss, D. G., Wang, Y., Zhu, H., & Zineh, I. (2019) · Clinical Pharmacology & Therapeutics

Pharmaceutical studies and practicesPharmaceutical Economics and Policy

Cited by 39

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

Bai, J. P. F., Schmidt, B. J., Gadkar, K. G., Damian, V., Earp, J. C., Friedrich, C., van der Graaf, P. H., Madabushi, R., Musante, C. J., Naik, K., et al. (2021) · The AAPS Journal

Statistical Methods in Clinical TrialsPharmaceutical studies and practices

Cited by 38

Using Quantitative Approaches to Optimize Dosages for New Combinations and Subsequent Indications for Oncology Drugs

Gao, W., Liu, J., Musante, C. J., Zhu, H., Thompson, M., Shah, M., Cao, Y., Ivaturi, V., Conaway, M. R., Bottino, D., et al. (2025) · Clinical Pharmacology & Therapeutics

Statistical Methods in Clinical TrialsPharmaceutical studies and practices

Cited by 2