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PDA TR 50

M00001932

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PDA TR 50 Technical Report No. 50 (TR 50) Alternative Methods for Mycoplasma Testing

Report / Survey by Parenteral Drug Association, 09/01/2010

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Using alternative methodology for the detection of mycoplasma requires validation and demonstration of comparability to reference standards. A PDA Task Force of experts has developed PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods. The report focuses on non-culture testing methodology, including Nucleic Acid Amplification Technique (NAT) assays and enzyme activity based assays. Representatives of the U.S. FDA and the U.S. Pharmacopeia contributed to the report.