Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets-Reference-Cited by-同舟云学术

Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets

Published:2016-07-27 Issue:9 Volume:13 Page:3256-3269
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Pepin Xavier J. H.¹,Flanagan Talia R.¹,Holt David J.¹,Eidelman Anna²,Treacy Don²,Rowlings Colin E.²

Affiliation:

1. AstraZeneca, Global Medicines Development, Pharmaceutical Development, Silk Road Business Park, Charter Way, Hurdsfield Industrial Estate, Macclesfield, SK10 2NA, U.K.

2. Ardea Biosciences, Pharmaceutical Sciences, 9390 Towne Centre Drive, San Diego, California 92121, United States

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.6b00497

Reference21 articles.

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3. Lionberger, R.Impact of Modelling and Simulation on Generic Drug Development and Review. OrBiTo Open Science Day, Paris, 1st July, 2015.http://orbitoproject.eu/sites/default/files/documents/3.%20OSD%20Robert%20Lionberger.pdf(accessed 05.05.16).

4. Computer simulations using GastroPlus™ to justify a biowaiver for etoricoxib solid oral drug products

5. Saag, K. G.; Adler, S.; Bhakta, N.; Fung, M.; Kopicko, J.; Storgard, C.; Bardin, T.Lesinurad, a Novel Selective Uric Acid Reabsorption Inhibitor, in Two Phase III Clinical Trials: Combination Study of Lesinurad in Allopurinol Standard of Care Inadequate Responders (CLEAR 1 and 2). ACR/ARHP Annual Meeting, 2014; Abstract Number L10.http://acrabstracts.org/abstract/lesinurad-a-novel-selective-uric-acid-reabsorption-inhibitor-in-two-phase-iii-clinical-trials-combination-study-of-lesinurad-in-allopurinol-standard-of-care-inadequate-responders-clear-1-and-2/(accessed 05.05.16).

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