MIC Testing Offered For Generic Antibiotic Evaluation At The Infection Control Services Laboratory

Generic antimicrobial agents are widely used, both in the public and private healthcare sectors. Generic products, which by definition contain the identical antimicrobial substance in the same dose (and dosage form) as the originator product, undergo pharmaceutical evaluation and limited microbiological testing, resulting in determination of pharmaceutical equivalence. However, they are not subjected to the intense and rigorous clinical trial work of the original agent, prior to registration. There is concern that generic antimicrobial agents may not be equivalent, or possibly inferior to the original agent in terms of clinical and microbiological outcomes, particularly in the setting of severe infections in critically ill patients. Clinicians and healthcare administrators alike have expressed a need for further evaluation of generic antimicrobial agents. The minimum inhibitory concentration (MIC) is the most widely used in vitro microbiological method used to evaluate antimicrobial agents. The method is standardised, reproducible and widely published. However, it is important to take note that MIC testing is a static assessment of microbiological activity and does not take into account host responses, thus pharmacokinetic issues are not addressed. Furthermore, pharmacodynamic parameters such as post-antibiotic effect and rate of bacterial killing are not taken into account. Nevertheless, it remains the current gold-standard for in vitro assessment of antimicrobial agents, both at the individual patient-level and for epidemiological surveillance purposes.

MIC testing is currently offered at the Infection Control Services Laboratory, NHLS for all generic antibiotic manufacturers.

If you require further information on the testing procedures or would be interested in getting your products assessed, please contact:

Dr Teena Thomas
Clinical Microbiologist
Address: Infection Control Services Laboratory, NHLS 3rd Floor Medical School Witwatersrand University
Tel: 011 489 9181/ 082 740 2897

OR

Crystal Viljoen
Laboratory Manager
Address: Infection Control Services Laboratory, NHLS 3rd Floor Medical School Witwatersrand University
Tel: 011 489 8578/ 081 851 3559