Bracketing Approach for Long-Acting Contraceptives
Author Information
Author(s): Cole Susan, Pertinez Henry, Butler Andrew S., Kerwash Essam, Bhat Swati, El-Khateeb Eman, Owen Andrew
Primary Institution: Medicines and Healthcare Products Regulatory Agency, UK
Hypothesis
Can a bracketing approach utilizing modeling support the development of long-acting injectables for regulatory approval?
Conclusion
The current understanding of exposure response is insufficient to support a bracketing approach for a new levonorgestrel product without additional safety data.
Supporting Evidence
- The study suggests that a bracketing approach could reduce the time and cost of developing new long-acting contraceptives.
- Current regulations may allow for reduced application packages if additional safety data are established.
- Levonorgestrel's target concentrations for efficacy are defined between 200–400 pg/mL.
Takeaway
This study looks at how to use existing data to help create new long-lasting contraceptives more quickly and cheaply.
Methodology
The study utilized literature evidence of levonorgestrel efficacy and safety, modeled data, and reviewed regulatory databases.
Potential Biases
Potential biases in real-world data due to reporting and publication issues.
Limitations
The concentration-response profiles are sparse and variable, making it challenging to define safety brackets.
Digital Object Identifier (DOI)
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