[1]
Wheeler, G.P. Studies related to the mechanism of action of cytotoxic alkylating agents: A review. Cancer Res., 1962, 22(6), 651-688.
[2]
Edward, C.; Edelson, R. Yale cancer center: Past, present, and future. Yale J. Biol. Med., 2006, 79(3-4), 199-200.
[3]
Weber, G.F. DNA-damaging drugs, WeberEd. Springer International Publishing Switzerland, 2015, Vol. 2,, 2-18.
[4]
Scholar, E. Alkylating agents. Biomed. Sci., 2007, 1-4.
[5]
Gilman, A. The initial clinical trial of nitrogen mustard. Am. J. Surg., 1963, 105(5), 574-578.
[6]
Kater, A.P. Efficacy and safety of first-line therapy with
Chlorambucil, Rituximab, and Lenalidomide (Revlimid®) (CR2) in
elderly patients and youngfrail patients with advanced Chronic
Lymphocytic Leukemia (CLL): A phase I/II trial. Hoven109 CLL, 2014, 6, 1-79.
[7]
Francesco, P.; Fermo, S.L. Lights and shadows of cyclophosphamide in the treatment of multiple sclerosis. Autoimmune Dis., 2011.961702
[8]
Brayfield, A. Cyclophosphamide: Martindale: The Complete Drug Reference, Medicines Complete Ed.;UK Pharmaceutical Press: London, 2017.
[9]
Devrieze, B.W.; Hurley, J.A. Goodpasture Syndrome (Antiglomerular
Basement Membrane Antibody Disease); Ed. Statpearls
Publishing LLC: Treasure Island, USA . , 2018.
[10]
Facon, T.; Mary, J.Y.; Hulin, C. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): A randomised trial. Lancet, 2007, 370(9594), 1209-1218.
[11]
Zalupski, M.; Baker, L.H. Ifosfamide. J. Natl. Cancer Inst., 1988, 80(8), 556-566.
[12]
Plosker, G.L.; Carter, N.J. Bendamustine: A review of its use in the management of indolent Non-Hodgkin lymphoma. Drugs, 2008, 68(18), 2645-2660.
[13]
Cancer statistics, 2018. CA Cancer J. Clin., 2018, 68(1), 7-30.
[15]
Vardanyan, R.; Hruby, V. Antineoplastics, Victor J. Hruby Ed.. Elsevier: Amsterdam,, 2006; pp. 389-418.
[16]
Sriram, D.; Yogeeswari., P. Anticancer Agents; Thomas Mathew, Ed. Pearson Education V: India,. , 2010, pp. 557-584.
[18]
Bunn, P.A.; Hoffman, S.J.; Norris, D.; Golitz, L.E.; Aeling, J.L. Systemic therapy of cutaneous T-cell lymphomas (mycosis fungoides and the Sezary syndrome). Ann. Intern. Med., 1994, 121(8), 592-602.
[19]
Huazhong, J.Q.S.L. A synthetic process of antineoplastic agents chlorambucil butyrate. Chinese Patent CN104447376B, , Nov 05 . 2014.
[20]
Walter, C.J.R.; Everett, J.L.; Roberts, J.J.N. N-Dichloroethylaminobutyrates and preparation thereof. U.S. Patent 2944079 , July 05. 1960.
[21]
Phillips, A.P. Tuckahoe; Mentha, J.W.; Hartsdale.; Method of making Chlorambucil. U. Patent 3046301,, July 24 . 1962.
[23]
Nedaa, I.; Sonnenburga, R.; Schmutzler, R.; Niemeyerb, U.; Kutscher, B.; Engel, J.; Kleemann, A. A new method for the preparation of ifosfamide and cyclophosphamide. J. Nat. Res., 1997, 52, 943-946.
[24]
Anon., Drugs of choice for cancer. Med. Lett., 2003, 1, 41-52.
[26]
Gurjar, M.K.; Tripathy, N.K.; Kotharkar, S.A.; Patil, P.N.; Mehta, S.S. Process for the preparation of melphalan hydrochloride. U.S. Patent 0116117 A1, May 10, . 2012.
[27]
Ashnagar, A.; Gharib Naseri, N.; Darakhshanmehr, M. Synthesis and elucidation of 4-bis(2-Chloroethyl)-amino-L-phenylalanine. Asian J. Chem., 2007, 19(7), 5399-5406.
[28]
Niemeyer, U.; Niege, H.; Kutscher, B.; Neda, I. Process for the
preparation of Oxaphosphorine-2-amines. U.S. Patent 0047103 A1, Nov 29. 2001.
[29]
Pankiewicz, K.; Kinas, R.; Stec, W.J.; Foster, A.B.; Jarman, M.; Van Maanen, J.M.S. Synthesis and absolute configuration assignments of enantiomeric forms of ifosphamide, sulfosphamide, and trofosphamide. J. Am. Chem. Soc., 1979, 101(26), 7712-7718.
[30]
Schickaneder, H. Eckental.; Schickaneder, C.; Lauf, A.D.; Pegnitz;
Limmert, M. Dresden.; Process for the preparation of bendamustine
hydrochloride and related compounds. U.S. Patent 2013/0184471 A1, Jul 18. 2013.
[31]
Mishra, B.B.; Shambhubha, N.; Kachhadia, ; Tomar, V.S.; Lahiri, S. Process for the preparation of bendamustine hydrochloride. U.S. Patent 2014/0121383 A1, May 1 . 2014.
[32]
Ozegowski, W.; Krebs, D. Aminosäureantagonisten. III. ω-[Bis-(β-chloräthyl)-amino-benzimidazolyl-(2)]-propion- bzw.-buttersäurenalspotentielle Cytostatika. J. Prakt. Chem., 1963, 20, 178-186.
[33]
Madkou, L.H. Biotechnology of nucleic acids medicines as gene therapeutics and their drug complexes. Chron. Pharma Sci, 2017, 1(4), 204-253.
[34]
Trituration of Mustargen, Merck & Co., Whitehouse Station, NJ 08889, USA, 741793X..
[35]
Bruce, A. Chabner, Bertino, J.; Cleary, J.; Ortiz, T.; Lane, A.; Supko, J.G.; Ryan, D. Cytotoxic compounds; Alkylating Agents and Platinum co-ordination complexes; Goodman & Gilman’s The Pharmacological Basis of Therapeutics; Ed. The McGraw-Hill Companies, Inc., 2011, pp. 1677-1678.
[36]
Beglleiter, A.; Mowat, M.; Israels, L.G.; Johnston, J.B. Chlorambucil in chronic lymphocytic leukemia: Mechanism of action. Leuk. Lymphoma, 1996, 23(3-4), 187-201.
[37]
Accessdata FDA, LEUKERAN Chlorambucil Tablet Prescribing
Information, Reference ID 3036543, GlaxoSmithKline, Research
Triangle Park, NC 27709..
[38]
Chighizola, C.; Ong, V.H.; Denton, C.P. Cyclophosphamide as disease-modifying therapy for scleroderma. Int. J. Clin. Rheumatol., 2011, 6(2), 219-230.
[39]
Tilby, M.J.; Hall, A.G. Mechanisms of action of, and modes of resistance to, alkylating agents used in the treatment of haematological malignancies. Blood Rev., 1992, 6(3), 163-173.
[40]
Emadi, A.; Jones, R.J.; Brodsky, R.A. Cyclophosphamide and cancer: Golden anniversary. Nat. Rev. Clin. Oncol., 2009, 6, 638-647.
[41]
Osborne, M.R.; Lawley, P.D.; Crofton-sleigh, C.; Warren, W. Products from alkylation of DNA in cells by melphalan: Human soft tissue sarcoma cell line RD and Escherichia coli WP2. Chem. Biol. Interact., 1995, 97(3), 287-296.
[42]
Povirk, L.F.; Shuker, D.E. DNA damage and mutagenesis induced by nitrogen mustards. Mutat. Res., 1994, 318(3), 205-226.
[43]
Highlights of prescribing information, EVOMELA; 2016.Reference ID 3900023, Spectrum Pharmace.uticals, Ins., Irvine,
CA 92618.
[44]
Furlanut, M.; Franceschi, L. Pharmacology of ifosfamide. Oncology, 2003, 65(2), 2-6.
[45]
Ifosfamide, injection solution; Highlights of prescribing
Information,; 2015.Teva Pharmaceuticals USA, Inc., North Wales,
PA 19454..
[46]
Struck, R.F.; Dykes, D.J.; Corbett, T.H.; Suling, W.J.; Trader, M.W. Isophosphoramide mustard, a metabolite of ifosfamide with activity against murine tumors comparable to Cyclophosphamide. Br. J. Cancer., 1983, 47, 015-026.
[47]
Accessdata, F.D.A. TREANDA Bendamustine hydrochloride for injection, for intravenous infusion, Highlights of Prescribing Information; , 2008. Cephalon Inc., Frazer, PA 19355.
[48]
Hartley, J.A. Alkylating agents. Oxford textbook of oncology.Ed. Oxford University Press, 2001, pp. 639-654.
[49]
Lorenzo, M. Leoni. Bendamustine: Rescue of an effective antineoplastic agent from the mid-twentieth century. Semin. Hematol., 2011, 48(1), S4-S11.
[50]
Cheson, B.D.; Leoni, L. Bendamustine: Mechanism of action and clinical data. Clin. Adv. Hematol. Oncol., 2011, 9(8), 19.
[51]
Arnau, M.; Eriong, L.; Jocabed, R.; Jiménez, L.; Cabezas, S.; Clot, G.; Pinyol, M.; Torrent, X.V.; Rosich, L.; Nardi, C.; Aymerich, M.; Villamor, N.; Guillermo, A.; Galan, P.; Roue, G.; Anglada, M.P.; Campo, E.; Guerra, L.; Colomer, D. CD69 expression potentially predicts response to bendamustine and its modulation by ibrutinib or idelalisib enhances cytotoxic effect in chronic lymphocytic leukemia. Oncotarget, 2016, 7(5), 5507-5520.
[52]
Kalaycio, M. Clinical experience with Bendamustine: A new treatment for patients with chronic lymphocytic leukemia. Clin. Leuk., 2008, 2, 223-229.
[53]
Accessdata, FDA, VALCHLOR, Mechlorethamine gel, for topical
use, Highlights of prescribing information,; , 2013. Reference ID 3362301, Ceptaris Therapeutics, Inc., Malvern, PA 19355.
[54]
Koler, R.D.; Forsgren, A.L. Hepatotoxicity due to Chlorambucil; report of a case. J. Am. Med. Assoc., 1958, 167(3), 316-317.
[55]
Fraiser, L.H.; Kanekal, S.; Kehrer, J.P. Cyclophosphamide toxicity. Characterizing and avoiding the problem. Drugs, 1991, 42(5), 781-795.
[56]
Accessdata, FDA, ALKERAN, Melphalan hydrochloride for
injection, Prescribing Information,; , 2002. GlaxoSmithKline,
Research Triangle Park, NC 27709..
[57]
Latcha, S.; Maki, R.G.; Schwartz, G.K.; Flombaum, C.D. Ifosfamide may be safely used in patients with end stage renal disease on hemodialysis. Sarcoma, 2009.Article ID 575629
[58]
Klastersky, J. Side effects of ifosfamide. Oncology, 2003, 65(2), 7-10.
[59]
Frisk, P.; Stalberg, E.; Stromberg, B.; Jakobson, A. Painful peripheral neuropathy after treatment with high-dose ifosfamide. Med. Pediatr. Oncol., 2001, 37(4), 379-382.
[60]
Knauf, W.U.; Lissichkov, T.; Aldaoud, A.; Liberati, A.; Loscertales, J.; Herbrecht, R.; Juliusson, G.; Postner, G.; Gercheva, L.; Goranov, S.; Becker, M.; Fricke, H.J.; Huguet, F.; Del, G.I.; Klein, P.; Tremmel, L.; Merkle, K.; Montillo, M. Phase III randomized study of Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J. Clin. Oncol., 2009, 27(26), 4378-4384.
[61]
Kahl, B.S.; Bartlett, N.L.; Leonard, J.P.; Chen, L.; Ganjoo, K.; Williams, M.E.; Czuczman, M.S.; Robinson, K.S.; Joyce, R.; Vander, J.R.H.; Cheson, B.D. Bendamustine is effective therapy in patients with Rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: Results from a Multicenter Study. Cancer, 2010, 116(1), 106-114.
[62]
Cheson, B.D.; Friedberg, J.W.; Kahl, B.S.; Vander, J.R.H.; Tremmel, L. Bendamustine produces durable responses with an acceptable safety profile in patients with Rituximab-refractory indolent non-Hodgkin lymphoma. Clin. Lymphoma Myeloma Leuk., 2010, 10(6), 452-457.
[63]
Fischer, K.; Cramer, P.; Busch, R.; Bottcher, S.; Bahlo, J.; Schubert, J.; Pfluger, K.H.; Schott, S.; Goede, V.; Isfort, S.; Von, T.J.; Fink, A.M.; Buhler, A.; Winkler, D.; Kreuzer, K.A.; Staib, P.; Ritgen, M.; Kneba, M.; Dohner, H.; Eichhorst, B.F.; Hallek, M.; Stilgenbauer, S.; Wendtner, C.M. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: A multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J. Clin. Oncol., 2012, 30(26), 3209-3216.
[64]
Ohmachi, K.; Niitsu, N.; Uchida, T.; Kim, S.J.; Ando, K.; Takahashi, N.; Takahashi, N.; Uike, N.; Eom, H.S.; Chae, Y.S.; Terauchi, T.; Tateishi, U.; Tatsumi, M.; Kim, W.S.; Tobinai, K.; Suh, C.; Ogura, M. Multicenter phase II study of bendamustine plus rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. J. Clin. Oncol., 2013, 31(17), 2103-2109.
[65]
Borchers, A.T.; Hagie, F.; Keen, C.L.; Gershwin, M.E. The history and contemporary challenges of the US Food and Drug Administration. Clin. Ther., 2007, 29(1), 1-16.
[66]
Stephen, B. Over-the-counter products in line for user fee program. Pharm. Therapeut., 2017, 42(12), 723-724.
[67]
Kaitin, K.; Melville, A.; Morris, B. FDA advisory committees and the new drug approval process. J. Clin. Pharmacol., 1989, 29(10), 886-890.
[68]
Cristancho, R.A.; Andia, T.; Barbosa, T.; Watanabe, J.H. Definition and classification of generic drugs across the world. Appl. Health Econ. Health Policy, 2015, 13(1), 5-11.
[69]
Thakkar, K.B.; Billa, G. The concept of Generic drugs and patented drugs vs. brand name drugs and non-proprietary (generic) name drugs. Front. Pharmacol., 2013, 4, 113.
[70]
Colombo, G.; Rosei, E.A.; Margonato, A.; Mencacci, A.; Maurizio, C.; Montecucco, C.M.; Trevisan, R. Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: A retrospective claims data study from five local healthcare units in the lombardy region of Italy. PLoS One, 2013, 8(12), 82990.
[71]
Garattini, L.; Vooren, K. Safety and quality of generic drugs: A never-ending debate fostered by economic interests? Appl. Health Econ. Health Policy, 2015, 13, 13-14.
[72]
Dunne, S.; Shannon, B.; Dunne, C.; Cullen, W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol. Toxicol., 2013, 14, 1.
[73]
Hansen, R.A.; Qian, J.; Berg, R.; Linneman, J.; Vazquez, E.S.; Dutcher, S.K.; Raofi, S.; David, C.; Peissig, P. Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs. Pharmacotherapy, 2017, 37(4), 429-437.
[74]
Barlas, S. Brand and generics companies unite to pressure FDA: They want the agency to drop its safety-label plan and adopt their alternative. PT, 2015, 40(8), 501-503.
[75]
Handoo, S.; Arora, V.; Khera, D.; Nandi, P.K.; Sahu, S.K. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. Int. J. Pharm. Investig., 2012, 2(3), 99-105.
[76]
Lionberger, A.; Lee, S.L.; Lee, L.M.; Raw, A.; Lawrence, X.Y. Quality by Design: Concepts for ANDAs. AAPS J., 2008, 10(2), 268-276.
[77]
Bedson, J.; Whitehurst, T.; Lewis, M.; Croft, P. Factors affecting over-the-counter use of aspirin in the secondary prophylaxis of cardiovascular disease. Br. J. Gen. Pract., 2001, 51(473), 1001-1003.
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