title: Review: Antimicrobial efficacy validation using in vitro and in vivo testing methods.
abstract: Pre-clinical antimicrobial validation testing for single and combination products, and parameters that should be considered when testing the antimicrobial performance of a medical device, are discussed. Guidance is provided on key elements required for in vitro and in vivo antimicrobial validation, including validation of microbial growth, microbial recovery, neutralization, and antimicrobial activity. An important consideration, both in terms of practicality and economics, is designing in vitro studies that bridge to in vivo testing: A representative in vitro model is used to generate data on many clinically relevant microorganisms, and then one microorganism is selected for use in in vivo testing. If the in vivo results correlate to the in vitro results, it can reasonably be extrapolated that the same would be true for the remaining microorganisms tested in vitro. Thus, the selection of relevant in vitro models for testing is critical for successful antimicrobial validation testing.
authors.affiliation: Innovotech, Inc., Suite 101, 2011 94 St., Edmonton, Alberta T6N 1H1, Canada. Electronic address: amin.omar@innovotech.ca.
authors.forename: Amin
authors.initials: A
authors.lastname: Omar
authors.affiliation: Innovotech, Inc., Suite 101, 2011 94 St., Edmonton, Alberta T6N 1H1, Canada.
authors.forename: Patricia
authors.initials: P
authors.lastname: Nadworny
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000494:pharmacology*; D004338:Drug Combinations; D006801:Humans; D008826:Microbial Sensitivity Tests; D054928:Validation Studies as Topic
chemical_list: D000890:Anti-Infective Agents; D004338:Drug Combinations
keywords: Animal model; Biofilm; Catheter; Chlorhexidine acetate (PubChem CID: 10144448); Chlorhexidine gluconate (PubChem CID: 9552081); Coated medical device; Elution; Formalin (PubChem CID: 712); Glutaraldehyde (PubChem CID: 3485); Ionic Silver (PubChem CID: 104755); Log reduction; MBEC™ (minimum biofilm eradication concentration); Minocycline (PubChem CID: 54675783); Rifampin (PubChem CID: 5381226); Silver sulfadiazine (PubChem CID: 441244); Single and combination antimicrobial agents; Sodium cacodylate (PubChem CID: 2724247); Vancomycin (PubChem CID: 14969)