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REVIEW;
The Efficacy and Safety of Sibutramine for Weight Loss: A Systematic Review
DOI 10.1001/archinte.164.9.994
Arterburn DE, Crane PK, Veenstra DL. The efficacy and safety of sibutramine for weight loss: a systematic review. Arch Intern Med. 2004;164(9):994-1003. (Pubitemid 38581520)
Safety pharmacology of sibutramine mesylate, an anti-obesity drug
DOI 10.1191/0960327105ht510oa
Kim EJ, Park EK, Suh KH. Safety pharmacology of sibutramine mesylate, an anti-obesity drug. Human Exper Toxicol. 2005;24(3):109-119. (Pubitemid 40605151)
Created August 29, 1996. Last updated December 6, 2007. Accessed May 2, 2008.
21 Code of Federal Regulations. Part 210 - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs. General Part 211 - Current good manufacturing practice for finished pharmaceuticals. http://www.fda.gov/cder/dmpq/cgmpregs.htm. Created August 29, 1996. Last updated December 6, 2007. Accessed May 2, 2008.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Impurities in New Drug Substances Q3A (R2). October 25, 2006.
European Medicines Evaluation Agency. European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use (CHMP). CPMP/SWP/5199/02. London, England. June 28
European Medicines Evaluation Agency. European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on the limits of genotoxic impurities. CPMP/SWP/5199/02. London, England. June 28, 2006.
Generic substitution: The use of medicinal products containing different salts and implications for safety and efficacy
Verbeeck RK, Kanfer I, Walker RB. Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy. Eur J Pharm Sci. 2006;28(1-2):1-6.
Pharmaceutical alternatives: Considerations for generic substitution
Kanfer I, Shargel L, eds. New York, NY: Informa Healthcare
Walker RB, Verbeek RK, Kanfer I. Pharmaceutical alternatives: considerations for generic substitution. In: Kanfer I, Shargel L, eds. Generic Drug Product Development: Bioequivalence Issues. New York, NY: Informa Healthcare; 2008:31-45.
Residues of genotoxic alkyl mesylates in mesylate salt drug substances: Real or imaginary problems
Snodin DJ. Residues of genotoxic alkyl mesylates in mesylate salt drug substances: real or imaginary problems. Reg Toxicol Pharmacol. 2006;45(1):79-90.
Francis PA. Viracept contamination. http://www.pharmabiz.com/article/ detnews.asp?SecArch=&articleid=40940§ionid=47. Published October 4, 2007. Accessed April 30, 2008.
Lewcock A. Regulators slate Roche 'lack of knowledge and understanding' in Viracept contamination case. http://www.gmptrainingsystems.com/PDF/Roche- contamination.pdf. Published November 23, 2007. Accessed April 30, 2008.