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The challenge to designing a Microbial Challenge Study
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Microbial challenge studies are non-compendial studies that evaluate the microbial growth potential of a product to determine safe holding time, storage conditions, and effectiveness of preservatives. These studies are often performed on sterile, non-preserved drug products that are prepared and/or penetrated for the purpose of final product preparation and are often held for a period of time before administration to the patient.
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