Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System

Author:

Sharan Satish,Choi Sungwoo,Zou Yuan,Wang Yan,Kim Myong-Jin,Fang Lanyan,Choi Stephanie,Makhlouf Fairouz,Grosser Stella C.,Zhang Xinyuan,Zhao Liang

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference20 articles.

1. Sharan S, Wang Y, Donnelly M, Zou Y, Fang L, Kim MJ, et al. Regulatory science to promote access to intrauterine systems for women in the United States. J Clin Pharmacol. 2020;60(Suppl 2):S34–8. https://doi.org/10.1002/jcph.1710.

2. Pregnancy prevention, birth control methods. U. S. Department of Health and Human Services (HHS), Office of Population Affairs (OPA); [02/10/2020]; Available from: https://www.hhs.gov/opa/pregnancy-prevention/birth-control-methods/index.html.

3. Birth Control. U.S Food & Drug Administration; [updated 02/11/202002/24/2020]; Available from: https://www.fda.gov/consumers/free-publications-women/birth-control.

4. Contraceptive Use in the United States. Guttmacher Institute; [updated 07/201802/25/2020]; Available from: https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states.

5. Birgisson NE, Zhao Q, Secura GM, Madden T, Peipert JF. Preventing unintended pregnancy: the contraceptive CHOICE project in review. J Womens Health (Larchmt). 2015;24(5):349–53. https://doi.org/10.1089/jwh.2015.5191.

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