Effectiveness or Efficacy: Which Study to Evaluate Antibiotics in Neonates?

Although the drug licensing process was introduced to ensure that medicines are safe, up to 90 % of products are used in an unauthorized or off-label manner in the neonatal population, especially if ne-onates are treated in neonatal intensive care units (NICUs). This is also the case for the use of mer-openem, a broad-spectrum antibiotic that is active against many multidrug-resistant bacteria. Meropenem is approved in the United States since 1996 and in Europe since 1997 for the treatment of bacterial meningitis and/or complicated intra-ab-dominal infections in children ≥