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1

Split-Cakes, Still Delicious.

Lam P, Patapoff TW. Lam P, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):16-29. doi: 10.5731/pdajpst.2018.008813. Epub 2018 Aug 29. PDA J Pharm Sci Technol. 2019. PMID: 30158240

2

Finite Element Method (FEM) Modeling of Freeze-drying: Monitoring Pharmaceutical Product Robustness During Lyophilization.

Chen X, Sadineni V, Maity M, Quan Y, Enterline M, Mantri RV. Chen X, et al. AAPS PharmSciTech. 2015 Dec;16(6):1317-26. doi: 10.1208/s12249-015-0318-9. Epub 2015 Mar 20. AAPS PharmSciTech. 2015. PMID: 25791415 Free PMC article.

3

Lyophilized Drug Product Cake Appearance: What Is Acceptable?

Patel SM, Nail SL, Pikal MJ, Geidobler R, Winter G, Hawe A, Davagnino J, Rambhatla Gupta S. Patel SM, et al. J Pharm Sci. 2017 Jul;106(7):1706-1721. doi: 10.1016/j.xphs.2017.03.014. Epub 2017 Mar 22. J Pharm Sci. 2017. PMID: 28341598

4

Improving Heat Transfer at the Bottom of Vials for Consistent Freeze Drying with Unidirectional Structured Ice.

Rosa M, Tiago JM, Singh SK, Geraldes V, Rodrigues MA. Rosa M, et al. AAPS PharmSciTech. 2016 Oct;17(5):1049-59. doi: 10.1208/s12249-015-0437-3. Epub 2015 Oct 26. AAPS PharmSciTech. 2016. PMID: 26502885

5

Next generation drying technologies for pharmaceutical applications.

Walters RH, Bhatnagar B, Tchessalov S, Izutsu KI, Tsumoto K, Ohtake S. Walters RH, et al. J Pharm Sci. 2014 Sep;103(9):2673-2695. doi: 10.1002/jps.23998. Epub 2014 Jun 10. J Pharm Sci. 2014. PMID: 24916125 Review.

6

Measurement of shrinkage and cracking in lyophilized amorphous cakes. Part I: final-product assessment.

Ullrich S, Seyferth S, Lee G. Ullrich S, et al. J Pharm Sci. 2015 Jan;104(1):155-64. doi: 10.1002/jps.24284. Epub 2014 Nov 24. J Pharm Sci. 2015. PMID: 25421825

7

Measurement of shrinkage and cracking in lyophilized amorphous cakes, part 3: hydrophobic vials and the question of adhesion.

Ullrich S, Seyferth S, Lee G. Ullrich S, et al. J Pharm Sci. 2015 Jun;104(6):2040-2046. doi: 10.1002/jps.24441. Epub 2015 Apr 1. J Pharm Sci. 2015. PMID: 25832825

8

An integrated process analytical technology (PAT) approach to monitoring the effect of supercooling on lyophilization product and process parameters of model monoclonal antibody formulations.

Awotwe Otoo D, Agarabi C, Khan MA. Awotwe Otoo D, et al. J Pharm Sci. 2014 Jul;103(7):2042-2052. doi: 10.1002/jps.24005. Epub 2014 May 19. J Pharm Sci. 2014. PMID: 24840395

9

New Processes for Freeze-Drying in Dual-Chamber Systems.

Werk T, Ludwig IS, Luemkemann J, Huwyler J, Mahler HC, Haeuser CR, Hafner M. Werk T, et al. PDA J Pharm Sci Technol. 2016 May-Jun;70(3):191-207. doi: 10.5731/pdajpst.2015.006155. Epub 2016 Feb 9. PDA J Pharm Sci Technol. 2016. PMID: 26865679

10

Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products.

Hottot A, Vessot S, Andrieu J. Hottot A, et al. PDA J Pharm Sci Technol. 2005 Mar-Apr;59(2):138-53. PDA J Pharm Sci Technol. 2005. PMID: 15971546

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