SPDS Set 1 ERP Book
PDE5-004
would be needed as well. Supporting Data
Multiple dietary supplement matrices need to be evaluated to provide an indication of the false positive/false negative rate. However, given this method measures activity and not concentration, it is a good indicator of the potency of the inhibitor, whereas molecular identification of PDE5 inhibitors that have been altered to escape detection would not provide.
General Comments
Method Optimization
Not described Performance Characteristics
Not described. However, indicated between 2.5 and 25 mg or a pharmacological dose. Concentrations are relative to the IC50 (inhibition concentration) relative to known PDE5 inhibitors (e.g. sildenafil, tadalafil, etc.)
Analytical Range:
LOQ: Accuracy/Recovery
Not described
Precision (RSDr)
Not described
Reproducibility (RSDR)
asdas
System Suitability
Safety Review Is the method safe to use as written? Safety for handling enzymes and solutions was not described
Are there any safety concerns with any component, instrument, reagent or instruction of the method? If yes, please clearly state the concerns. Does the method include all necessary safety precautions and/or warning statements? Yes or No. If No, please suggest potential precautions or warnings that can be added to the method for users or recommend safer option(s) if warranted.
There should be statement of safety or precautionary measures when handling reagents and there are none.
No. Handling of reagents and enzymes need to have some statement of safety and handling procedure requirements.
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