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References 1.


3. 4. 5. 6. 7. 8. 9.


10. J. Andhariya, N.Swarnakar, J. Shen, W. Qu, Y. Wang, S. Choi, and D. Burgess, Eff ect of manufacturing processes on critical quality attributes of naltrexone microspheres. Controlled Release Society Annual Meeting, 2016.


21 CFR 314.94(a)(9)(iii)


2. FDA. GDUFA Regulatory Science. Available at: http://www.fda.gov/ForIndustry/UserFees/ GenericDrugUserFees/ucm370952.htm.


J. Shen, W.Qu, S. Choi, Y. Wang, and D. Burgess, In vitro and in vivo performance testing of risperidone microspheres. American Association of Pharmaceutical Scientists, 2014.


J. Shen, W.Qu, S. Choi, Y. Wang, and D. Burgess, Development of an in vitro release testing method for porous PLGA microspheres. American Association of Pharmaceutical Scientists, 2014.


J. Shen, N.Tipins, S. Choi, W. Qu, Y. Wang, and D. Burgess, In vitro-in vivo correlation of risperidone microspheres. Controlled Release Society Annual Meeting, 2015.


J. Andhariya, J.Shen, W. Qu, Y. Wang, S. Choi, and D. Burgess, Storage stability tests of risperidone-loaded PLGA microspheres. American Association of Pharmaceutical Scientists, 2015.


J.Shen, W.Qu, Y. Wang, S. Choi, and D. Burgess, Eff ect of manufacturing process parameters on physicochemical properties of peptide microspheres. American Association of Pharmaceutical Scientists, 2015.


N. Swarnakar, J.Shen, W. Qu, S. Choi, Y. Wang, and D. Burgess, Development of an accelerated in vitro release testing method for vivitrol®. American Association of Pharmaceutical Scientists, 2015.


J. Shen, W.Qu, S. Choi, Y. Wang, and D. Burgess, Effect of manufacturing processes on in vitro performance of peptide microspheres. Controlled Release Society Annual Meeting, 2016.


11. A. Doty, Y.Wang, S. Choi, W. Qu, R. Lionberger, M. Feng, A. Schwendeman, S. Schwendeman, Cage implant system to evaluate mechanisms of in vivo PLGA microsphere release for IVIVC model development. American Association of Pharmaceutical Scientists, 2014.


12. A. Doty, K.Hirota, R. Ackermann, K. Olsen, R. Feng, W. Qu, Y. Wang, S. Choi, A. Schwendeman, and S. Schwendeman, A cage implant system for assessing in vivo controlled release performance of long-acting release PLGA microspheres. American Association of Pharmaceutical Scientists, 2015.


13. K. Hirota, A.Doty, R. Ackermann, K. Olsen, M. Feng, Y. Wang, S. Choi, W. Qu, A. Schwendeman, and S. Schwendeman, Characterizing release methanisms of leuprolide-loaded PLGA microparticles for IVIVC development. American Association of Pharmaceutical Scientists, 2015.


14. S. Schwendeman, K.Hirota, A. Doty, Y. Wang, S. Choi, and W. Qu, Mechanistic evaluation of in vitro and in vivo release from PLGA microspheres employing a cage model. 14th European Symposium on Controlled Drug Delivery, 2016.


15. J. Shen, S.Choi, W. Qu, Y. Wang, and D. Burgess, In vitro-in vivo correlation of parenteral risperidone polymeric microspheres. Journal of Controlled Release, 2015. 218: p. 2-12.


16. J. Shen, K.Lee, S. Choi, W. Qu, Y. Wang, and D. Burgess, A reproducible accelerated in vitro release testing method for PLGA microspheres. International Journal of Pharmaceutics, 2016. 498: p. 274-282.


17. J. Garner, S.Skidmore, H. Park, K. Park, S. Choi, and Y. Wang, A protocol for assay of poly(lactide-co-glycolide) in clinical products. International Journal of Pharmaceutics, 2015. 495: p. 87-92.


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