Generic antibiotics, antibiotic resistance, and drug licensing.

摘要: 754 www.thelancet.com/infection Vol 10 November 2010 and bioequivalence to the original agent. There is currently no regulatory requirement show effi cacy of approved indications or target pathogens, despite major changes in prevailing rates resistance. also monitor antibiotic resistance trends yardstick by which triggers a review prescribing indications. Prescribers deserve reassurance that licensed agents remain fi t for purpose. The situation remains unsatisfactory provides false sense security. Furthermore, generic dominating guidance disincentive development new medicines. Regulatory authorities should review, hopefully resolve, these weaknesses market authorisation many antibiotics.