A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials-Reference-Cited by-同舟云学术

A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials

Published:2022-04-06 Issue:3 Volume:24 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Dockendorf Marissa F.,Jaworowicz David,Humphrey Rebecca,Anderson Melanie,Breidinger Sheila,Ma Lei,Taylor Theresa,Dupre Nicole,Jones Christopher,Furtek Christine,Kantesaria Bhavna,Bateman Kevin P.,Woolf Eric,Egan Michael F.,Stone Julie A.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

https://link.springer.com/content/pdf/10.1208/s12248-022-00682-5.pdf

Reference14 articles.

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2. Scott JD, Li SW, Brunskill AP, Chen X, Cox K, Cumming JN, et al. Discovery of the 3-imino-1,2,4-thiadiazinane 1,1-dioxide derivative verubecestat (MK-8931)-a β-site amyloid precursor protein cleaving enzyme 1 inhibitor for the treatment of Alzheimer’s Disease. J Med Chem. 2016;59(23):10435–50.

3. Kennedy ME, Stamford AW, Chen X, Cox K, Cumming JN, Dockendorf MF, et al. The BACE1 inhibitor verubecestat (MK-8931) reduces CNS β-amyloid in animal models and in Alzheimer’s disease patients. Sci Transl Med. 2016;8(363):363ra150.

4. Min KC, Dockendorf MF, Palcza J, Tseng J, Ma L, Stone JA, et al. Pharmacokinetics and pharmacodynamics of the BACE1 inhibitor verubecestat (MK-8931) in healthy Japanese adults: a randomized, placebo-controlled study. Clin Pharmacol Ther. 2019;105(5):1234–43.

5. Forman M, Palcza J, Tseng J, Stone JA, Walker B, Swearingen D, Troyer MD, Dockendorf MF. Safety, tolerability, and pharmacokinetics of the beta-site amyloid precursor protein-cleaving enzyme 1 inhibitor verubecestat (MK-8931) in healthy elderly male and female subjects. Clin Transl Sci. 2019;12(5):545–55.

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