A perspective on testing of existing pharmaceutical excipients for genotoxic impurities.
Guidance recommendations by the Committee for Medicinal Products for Human Use (CHMP) and Pharmaceutical Research and Manufacturers of America (PhRMA) acknowledge the presence of potential toxic impurities in some pharmaceutical ingredients and have proposed setting limits on impurities with genotoxic activity as a means to protect patients in clinical trials and for marketing of the approved products. Recently, there have been suggestions that drug excipients, including existing products, should also be subjected to the same testing procedures and intake limits as proposed for active ingredients. This report is an attempt to put such recommendations into the proper perspective regarding the likelihood of protecting or improving public health.
Brusick
David J
DJ
brusick41@aol.com
D004269:DNA, Bacterial / Q000187:drug effects; D004340:Drug Contamination / Q000517:prevention & control*; D005079:Excipients / Q000737:chemistry / Q000145:classification / Q000633:toxicity*; D005506:Food Contamination / Q000032:analysis; D006801:Humans; D009152:Mutagenicity Tests / Q000379:methods*; D009153:Mutagens / Q000737:chemistry / Q000145:classification / Q000633:toxicity*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011634:Public Health; D018570:Risk Assessment; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics
D004269:DNA, Bacterial; D005079:Excipients; D009153:Mutagens; D004364:Pharmaceutical Preparations