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).