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Page 1
Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.
Van Buskirk GA, Asotra S, Balducci C, Basu P, DiDonato G, Dorantes A, Eickhoff WM, Ghosh T, González MA, Henry T, Howard M, Kamm J, Laurenz S, MacKenzie R, Mannion R, Noonan PK, Ocheltree T, Pai U, Poska RP, Putnam ML, Raghavan RR, Ruegger C, Sánchez E, Shah VP, Shao ZJ, Somma R, Tammara V, Thombre AG, Thompson B, Timko RJ, Upadrashta S, Vaithiyalingam S; Manufacturing Technical Committee of the Product Quality Research Institute. Van Buskirk GA, et al. Among authors: noonan pk. AAPS PharmSciTech. 2014 Jun;15(3):665-93. doi: 10.1208/s12249-014-0087-x. Epub 2014 Mar 1. AAPS PharmSciTech. 2014. PMID: 24578237 Free PMC article. Review.
Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles.
Van Buskirk GA, Arsulowicz D, Basu P, Block L, Cai B, Cleary GW, Ghosh T, González MA, Kanios D, Marques M, Noonan PK, Ocheltree T, Schwarz P, Shah V, Spencer TS, Tavares L, Ulman K, Uppoor R, Yeoh T. Van Buskirk GA, et al. Among authors: noonan pk. AAPS PharmSciTech. 2012 Mar;13(1):218-30. doi: 10.1208/s12249-011-9740-9. Epub 2012 Jan 4. AAPS PharmSciTech. 2012. PMID: 22215291 Free PMC article. Review.
Evaluation of orally administered highly variable drugs and drug formulations.
Shah VP, Yacobi A, Barr WH, Benet LZ, Breimer D, Dobrinska MR, Endrenyi L, Fairweather W, Gillespie W, Gonzalez MA, Hooper J, Jackson A, Lesko LJ, Midha KK, Noonan PK, Patnaik R, Williams RL. Shah VP, et al. Among authors: noonan pk. Pharm Res. 1996 Nov;13(11):1590-4. doi: 10.1023/a:1016468018478. Pharm Res. 1996. PMID: 8956322 Review. No abstract available.
Scale-up of adhesive transdermal drug delivery systems.
Van Buskirk GA, González MA, Shah VP, Barnhardt S, Barrett C, Berge S, Cleary G, Chan K, Flynn G, Foster T, Gale R, Garrison R, Gochnour S, Gotto A, Govil S, Gray VA, Hammar J, Harder S, Hoiberg C, Hussain A, Karp C, Llanos H, Mantelle J, Noonan P, Zrebe H, et al. Van Buskirk GA, et al. Pharm Res. 1997 Jul;14(7):848-52. doi: 10.1023/a:1012135430056. Pharm Res. 1997. PMID: 9244139 Free article. No abstract available.
Dose proportionality of transdermal nitroglycerin.
Jewell RC, Banfield CR, Ruggirello DA, Huang YW, Noonan PK, Gonzalez MA. Jewell RC, et al. Among authors: noonan pk. Pharm Res. 1992 Oct;9(10):1284-9. doi: 10.1023/a:1015853200537. Pharm Res. 1992. PMID: 1448427
30 results