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Application of the model-informed drug development paradigm to datopotamab deruxtecan dose selection for late-stage development.
Lu Y, Liang S, Hong Y, Tajima N, Patel K, Li H, Wada DR, Greenberg J, Petrich A, Zebger-Gong H, Shuster D, Vaddady P. Lu Y, et al. Among authors: vaddady p. CPT Pharmacometrics Syst Pharmacol. 2024 Jan;13(1):23-28. doi: 10.1002/psp4.13058. Epub 2023 Nov 1. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 37915242 Free PMC article. Clinical Trial.
Artificial Intelligence for Quantitative Modeling in Drug Discovery and Development: An Innovation and Quality Consortium Perspective on Use Cases and Best Practices.
Terranova N, Renard D, Shahin MH, Menon S, Cao Y, Hop CECA, Hayes S, Madrasi K, Stodtmann S, Tensfeldt T, Vaddady P, Ellinwood N, Lu J. Terranova N, et al. Among authors: vaddady p. Clin Pharmacol Ther. 2024 Apr;115(4):658-672. doi: 10.1002/cpt.3053. Epub 2023 Oct 6. Clin Pharmacol Ther. 2024. PMID: 37716910 Review.
Leveraging a Clinical Phase Ib Proof-of-Concept Study for the GPR40 Agonist MK-8666 in Patients With Type 2 Diabetes for Model-Informed Phase II Dose Selection.
Krug AW, Vaddady P, Railkar RA, Musser BJ, Cote J, Ederveen A, Krefetz DG, DeNoia E, Free AL, Morrow L, Chakravarthy MV, Kauh E, Tatosian DA, Kothare PA. Krug AW, et al. Among authors: vaddady p. Clin Transl Sci. 2017 Sep;10(5):404-411. doi: 10.1111/cts.12479. Epub 2017 Jul 20. Clin Transl Sci. 2017. PMID: 28727908 Free PMC article. Clinical Trial.
Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Children with Confirmed or Suspected Gram-Negative Bacterial Infections: A Phase 1b, Open-Label, Single-Dose Clinical Trial.
Bradley JS, Makieieva N, Tøndel C, Roilides E, Kelly MS, Patel M, Vaddady P, Maniar A, Zhang Y, Paschke A, Chen LF. Bradley JS, et al. Among authors: vaddady p. J Clin Pharmacol. 2023 Dec;63(12):1387-1397. doi: 10.1002/jcph.2334. Epub 2023 Sep 2. J Clin Pharmacol. 2023. PMID: 37562063 Clinical Trial.
Incorporating protein precipitation to resolve hybrid IP-LC-MS assay interference for ultrasensitive quantification of intact therapeutic insulin dimer in human plasma.
Sun L, Xu Y, Dube N, Anderson M, Breidinger S, Vaddady P, Thornton B, Morrow L, Matthews RP, Stoch SA, Woolf EJ. Sun L, et al. Among authors: vaddady p. J Pharm Biomed Anal. 2022 Apr 1;212:114639. doi: 10.1016/j.jpba.2022.114639. Epub 2022 Feb 2. J Pharm Biomed Anal. 2022. PMID: 35176654
17 results