PDA TR 50

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

Parenteral Drug Association , 09/01/2010

Publisher: PDA

File Format: PDF

$162.00$325.00


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.

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