1. US Food and Drug Administration. Determination that Delalutin (hydroxyprogesterone caproate) injection, 125 milligrams/milliliter and 250 milligrams/milliliter, was not withdrawn from sale for reasons of safety or effectiveness. Federal Register. 2010. Available at:https://www.federalregister.gov/documents/2010/06/25/2010-15416/determination-that-delalutin-hydroxyprogesterone-caproate-injection-125-milligramsmilliliter-and-250. Accessed December 30, 2022.
2. US Food and Drug Administration. Drugs@FDA: FDA-approved drugs. Available at:https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021945. Accessed December 30, 2022.
3. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: exposure-response relationships — study design, data analysis, and regulatory applications. 2003. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Available at: https://www.fda.gov/media/71277/download. Accessed December 30, 2022.
4. Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth;Caritis;Am J Obstet Gynecol,2014
5. US Food and Drug Administration. Guideline for industry dose-response information to support drug registration. 1994. Available at:https://www.fda.gov/media/71279/download#:∼:text=Although%20including%20a%20placebo%20group,evidence%20of%20a%20drug%20effect. Accessed December 30, 2022.