Cook JA - Search Results

1

The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.

Selen A, Dickinson PA, Müllertz A, Crison JR, Mistry HB, Cruañes MT, Martinez MN, Lennernäs H, Wigal TL, Swinney DC, Polli JE, Serajuddin ATM, Cook JA, Dressman JB. Selen A, et al. Among authors: cook ja. J Pharm Sci. 2014 Nov;103(11):3377-3397. doi: 10.1002/jps.24162. Epub 2014 Sep 24. J Pharm Sci. 2014. PMID: 25256402 Review.

2

Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.

Dickinson PA, Kesisoglou F, Flanagan T, Martinez MN, Mistry HB, Crison JR, Polli JE, Cruañes MT, Serajuddin ATM, Müllertz A, Cook JA, Selen A. Dickinson PA, et al. Among authors: cook ja. J Pharm Sci. 2016 Nov;105(11):3243-3255. doi: 10.1016/j.xphs.2016.07.024. Epub 2016 Sep 19. J Pharm Sci. 2016. PMID: 27659159 Review.

3

Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.

Selen A, Müllertz A, Kesisoglou F, Ho RJY, Cook JA, Dickinson PA, Flanagan T. Selen A, et al. Among authors: cook ja. AAPS J. 2020 Jul 27;22(5):97. doi: 10.1208/s12248-020-00470-z. AAPS J. 2020. PMID: 32719954

4

Quality-by-design: are we there yet?

Cook J, Cruañes MT, Gupta M, Riley S, Crison J. Cook J, et al. AAPS PharmSciTech. 2014 Feb;15(1):140-8. doi: 10.1208/s12249-013-0043-1. Epub 2013 Nov 12. AAPS PharmSciTech. 2014. PMID: 24218058 Free PMC article.

5

Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.

Selen A, Cruañes MT, Müllertz A, Dickinson PA, Cook JA, Polli JE, Kesisoglou F, Crison J, Johnson KC, Muirhead GT, Schofield T, Tsong Y. Selen A, et al. Among authors: cook ja. AAPS J. 2010 Sep;12(3):465-72. doi: 10.1208/s12248-010-9206-0. Epub 2010 Jun 2. AAPS J. 2010. PMID: 20517660 Free PMC article.

6

Impact of Biopharmaceutics Classification System-based biowaivers.

Cook JA, Davit BM, Polli JE. Cook JA, et al. Mol Pharm. 2010 Oct 4;7(5):1539-44. doi: 10.1021/mp1001747. Epub 2010 Sep 7. Mol Pharm. 2010. PMID: 20735084

7

Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.

Selen A, Müllertz A, Kesisoglou F, Ho RJY, Cook JA, Dickinson PA, Flanagan T. Selen A, et al. Among authors: cook ja. AAPS J. 2020 Dec 3;23(1):7. doi: 10.1208/s12248-020-00534-0. AAPS J. 2020. PMID: 33270171

8

ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium.

Bransford P, Cook J, Gupta M, Haertter S, He H, Ju R, Kanodia J, Lennernäs H, Lindley D, Polli JE, Wenning L, Wu Y. Bransford P, et al. Mol Pharm. 2020 Feb 3;17(2):361-372. doi: 10.1021/acs.molpharmaceut.9b01062. Epub 2020 Jan 7. Mol Pharm. 2020. PMID: 31846335

9

Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.

Polli JE, Yu LX, Cook JA, Amidon GL, Borchardt RT, Burnside BA, Burton PS, Chen ML, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VH, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I, Zhang G. Polli JE, et al. Among authors: cook ja. J Pharm Sci. 2004 Jun;93(6):1375-81. doi: 10.1002/jps.20064. J Pharm Sci. 2004. PMID: 15124197 No abstract available.

10

Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019.

Khong YM, Liu J, Cook J, Purohit V, Thompson K, Mehrotra S, Cheung SYA, Hay JL, Fletcher EP, Wang J, Sachs HC, Zhu H, Siddiqui A, Cunningham L, Selen A. Khong YM, et al. Eur J Pharm Biopharm. 2021 Jul;164:66-74. doi: 10.1016/j.ejpb.2021.04.010. Epub 2021 Apr 18. Eur J Pharm Biopharm. 2021. PMID: 33878434

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