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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: ocheltree t. 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: ocheltree t. 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.
Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.
Malik SM, Liu K, Qiang X, Sridhara R, Tang S, McGuinn WD Jr, Verbois SL, Marathe A, Williams GM, Bullock J, Tornoe C, Lin SC, Ocheltree T, Vialpando M, Kacuba A, Justice R, Pazdur R. Malik SM, et al. Among authors: ocheltree t. Clin Cancer Res. 2010 Oct 15;16(20):4921-7. doi: 10.1158/1078-0432.CCR-10-1214. Epub 2010 Aug 25. Clin Cancer Res. 2010. PMID: 20739433 Review.
FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation.
Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. Brave M, et al. Among authors: ocheltree t. Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8. Oncology. 2010. PMID: 20530974
Physiological trait networks enhance understanding of crop growth and water use in contrasting environments.
Gleason SM, Barnard DM, Green TR, Mackay S, Wang DR, Ainsworth EA, Altenhofen J, Brodribb TJ, Cochard H, Comas LH, Cooper M, Creek D, DeJonge KC, Delzon S, Fritschi FB, Hammer G, Hunter C, Lombardozzi D, Messina CD, Ocheltree T, Stevens BM, Stewart JJ, Vadez V, Wenz J, Wright IJ, Yemoto K, Zhang H. Gleason SM, et al. Among authors: ocheltree t. Plant Cell Environ. 2022 Sep;45(9):2554-2572. doi: 10.1111/pce.14382. Epub 2022 Jul 7. Plant Cell Environ. 2022. PMID: 35735161
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