UMDNJ Develops Rapid Detection Test for Exserhilum rostratum in Response to Compounding Pharmacy Deaths
A rapid detection test for Exserhilum rostratum, the fungus primarily responsible for 39 deaths a…
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA