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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: sinha v. 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.
Development of a Disease Progression Model for Leucine-Rich Repeat Kinase 2 in Parkinson's Disease to Inform Clinical Trial Designs.
Ahamadi M, Conrado DJ, Macha S, Sinha V, Stone J, Burton J, Nicholas T, Gallagher J, Dexter D, Bani M, Boroojerdi B, Smit H, Weidemann J, Chen C, Yang M, Maciuca R, Lawson R, Burn D, Marek K, Venuto C, Stafford B, Akalu M, Stephenson D, Romero K; Critical Path for Parkinson's (CPP) Consortium. Ahamadi M, et al. Among authors: sinha v. Clin Pharmacol Ther. 2020 Mar;107(3):553-562. doi: 10.1002/cpt.1634. Epub 2019 Dec 5. Clin Pharmacol Ther. 2020. PMID: 31544231 Free PMC article.
724 results