References
- Rowlands, M. G.; Barrie, S. E.; Chen, F.; Houghton, J.; Jarman, M.; McCague, R.; Potter, G. A. Esters of 3-pyridylcetic acid that combine potent inhibitor of 17.alpha.-hydroxaylase/C17,20-lyase (cytochrome P45017.alpha.) with Resistance to Esterase Hydrolysis. J. Med. Chem. 1995, 38(21), 4191–4197.
- Sonpavde, G.; Attard, G.; Bellmunt, J.; Mason, M. D.; Malavaud, B.; Tombal, B.; Stemberg, C. N. The role of Abiterone acetate in the management of prostate cancer: A critical analysis of the literature. Eur. Urol. 2011, 60(2), 270–278.
- Hunt, N. J. Methanesulfonate salts of abiterone -3-esters and recovery of salts of Abiraterone one-3-esters from solution in methyl tetra-butyl ether. United States Patent. Pub.no:US 2010/0152437 A1.
- Acharya, M.; Bernard, A.; Gonzalez, M.; Jiao, J.; De Vries, R.; Tran, N. Open label, phase 1, pharmacokinetic studies of abiraterone acetate in healthy men. Cancer Chemother. Pharmacol. 2012, 69(6), 1583–1590.
- Sarker, H.; Miksinski, S. United States food and drug administration, center for drug evaluation and research, chemistry review (S), application number: 202379 Orig 1s000, NAD, 202379, 2011.
- O'Donnell, A.; Judson, I.; Dowsett, M.; Reynaud, F.; Dearnaley, D.; Mason, M.; Harland, S.; Robbins, A.; Halbert, G.; Nutley, B.; Jarman, M. Hormonal impact of the 17α-hydroxylase/C17,20-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br. J. Cancer 2004, 90(12), 2317–2325.
- Heidegger, I.; Massoner, P.; Eder, I. E.; Pircher, A.; Pircher, R.; Aigner, F.; Bekitc, J.; Horninger, W.; Klocker, H. Novel therapeutic approaches for the treatment of castration-resistant prostate cancer. J. Sterioid Biochem. Mol. Biol. 2013, 138, 248–256.
- Beckett, R. D.; Rodeffer, K. M.; Snodgrass, R. Abiraterone for the treatment of metastatic castrate-resistance prostate cancer. Ann. Pharmacother. 2012, 46(7–8), 1016–1024.
- Marbury, T.; Lawitz, E.; Stonerock, R.; Gonzalez, M.; Jiao, J.; Breeding, J.; Haqq, C.; Verboven, P. V.; Stieltjes, H.; YU, M.; Molina, A.; Acharya, M.; Chine, C.; Tran, N. Single-dose pharmacokinetic studies of Abiraterone acetate in men with hepatic or renal impairment. J. Clin. Pharmacol. 2014, 54(7), 732–741.
- Zytiga tablets (2011) manufactured by Patheon Inc., Toronto, Canada, manufactured for, Centocor Ortho Biotech Inc., Horsham, PA.
- Martins, V.; Asad, Y.; Wilsher, N.; Rayanaud, F. A validated liquid chromatographic–tandem mass spectroscopy method for the quantification of Abiraterone acetate and Abiraterone in human plasma. J. Chromatogr. B 2006, 843(2), 262–267.
- Kumar, S. V.; Rudresha, G.; Gurav, S.; Zainuddina, M.; Dewang, P.; Kethiri, R. R.; Rajagopal, S.; Mullangi, R. Validated RP-HPLC/UV method for the quantitation of Abiraterone acetate in rat plasma and its application to a pharmacokinetic study in rats. Biomed. Chromatogr. 2012, 27(2), 203–207.
- Sandip, G.; Ravindra, P.; Junaid, F.; Zainuddin, M.; Rajagopal, S.; Ramesh, M. Development and validation of a highly sensitive method for the determination of Abiraterone in rat and human plasma by LC-MS/MS-ESI application to a pharmacokinetic study. Biomed. Chromatogr. 2012, 26(6), 761–768.
- Khedra, A.; Darwishib, I.; Bamanea, F. Analysis of Abiraterone acetate stress degradation behaviour using liquid chromatography coupled to ultraviolet detection and electrone ionization mass spectrometry. J. Pharm. Biomed. Anal. 2013, 74, 77–82.
- Wani, T. A. Highly sensitive ultra-performance liquid chromatography–tandaem mass spectrometry method for the determination of Abiraterone in human plasma. Anal. Methods 2013, 5(15), 3693–3699.
- Belleville, T.; Noe, G.; Huillard, O.; Thomas-Schoemann, A.; Vidal, M.; Goldwasser, F.; Alexandre, J.; Blanchet, B. A HPLC-fluorescence method for the quantification of Abiraterone acetate in plasma from patients with metastatic castration-resistant prostate cancer. J. Chromatogr. B 2015, 989, 86–90.
- Singh, S.; Junwal, M. J.; Modhe, G.; Tiwari, H.; Kurmi, M.; Parashar, N.; Sidduri, P. Forced degradation studies to assess the stability of drugs and products. TrAc Trends Anal. Chem. 2013, 49, 71–88.
- Blessy, M.; Patel, R. D.; Prajesh, N. P.; Agrawal, Y. K. Development of forced degradation and stability indicating studies of drugs–A review. J. Pharm. Anal. 2014, 4(3), 159–165.
- Jain, D.; Basniwal, P. K. Forced degradation and impurity profling recent trends in analytical perspectives. J. Pharm. Biomed. Anal. 2013, 86, 11–35.
- Sharma, A.; Sharma, R. Validation of analytical procedures: A comparison of ICH vs. Pharmacopoeia (USP) and FDA. Int. Res. J. Pharm. 2012, 3(6), 39–42.
- ICH, Q2 (R1) International Conference on Harmonization, Validation of analytical procedures: text and methodology, Geneva: IFPMA, 2005.
- ICH, Q1A (R2) International Conference on Harmonization, Stability Testing of New Drug Substances and Products, Geneva: IFPMA, 2003.
- USP 37/NF 32. The United States Pharmacopeia National Formulary; 32th edn. United States Pharmacopeial Convention Inc: Rochville, MD, 2013.
- Snyder, L. R.; Joseph, J. K. Practical HPLC Method Development; 2nd edn. John Wiley & Sons Publication: Hoboken, NJ, 2002; 21–173 pp.