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Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagao L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Galluppi GR, et al. Among authors: mukherjee a. Clin Pharmacol Ther. 2021 Nov;110(5):1172-1175. doi: 10.1002/cpt.2265. Epub 2021 May 15. Clin Pharmacol Ther. 2021. PMID: 33991429 Free PMC article. Review. No abstract available.
Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval-An Industry Perspective.
Zhu R, Vora B, Menon S, Younis I, Dwivedi G, Meng Z, Datta-Mannan A, Manchandani P, Nayak S, Tammara BK, Garhyan P, Iqbal S, Dagenais S, Chanu P, Mukherjee A, Ghobadi C; International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Real-World Data Working Group. Zhu R, et al. Among authors: mukherjee a. Clin Pharmacol Ther. 2023 Oct;114(4):751-767. doi: 10.1002/cpt.2988. Epub 2023 Jul 29. Clin Pharmacol Ther. 2023. PMID: 37393555 Review.
4,196 results