Three requirements for a medicine

Epidyolex complies with the principal regulatory requirements for a medicine:1

Efficacy

 

 

Studied in randomised Phase III clinical trials, evaluating efficacy and dosing compared to placebo.

 

 

 

Generally well tolerated

 

 

Comprehensive pre-clinical programme examining toxicity, drug-drug interactions, pharmacology, dosing and abuse potential; as well as extensive clinical trials.

 

 

 

Quality

 

 

Manufactured to GxP standards and complies with regulatory medicine standards, ensuring:

 

 

  • Freedom from contaminants such as pesticides, heavy metals and aflatoxins
  • Batch-to-batch consistency
  • A stable shelf life
  • Continuous investment in process and facilities

 

GxP, Good Practice.

 

 

 

 

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References

 

1. Epidyolex Summary of Product Characteristics (Date accessed: 03/09/2020).