Joshua Brown , Tamra Goodrow , Dan Hartman , Justin L. Hay , Kevin Hershberger , Susan Hershenson , Douglas McNair , Bethany Matthews , Mark A. Milad , Stephan Schmidt , Kirsten M Vogelsong , Ping Zhao
{"title":"应用曝光法简化避孕产品的开发","authors":"Joshua Brown , Tamra Goodrow , Dan Hartman , Justin L. Hay , Kevin Hershberger , Susan Hershenson , Douglas McNair , Bethany Matthews , Mark A. Milad , Stephan Schmidt , Kirsten M Vogelsong , Ping Zhao","doi":"10.1016/j.conx.2022.100072","DOIUrl":null,"url":null,"abstract":"<div><p>Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of such products traditionally follow a conventional paradigm that includes large Phase 3 clinical trials to evaluate efficacy (pregnancy prevention) and safety of the investigational product. Exposure-bracketing is a concept that applies known pharmacokinetics and pharmacodynamics of a drug substance to inform its safe and efficacious use in humans. Several therapeutic areas have applied this concept by leveraging established drug concentration-response relationships for approved products to expedite development and shorten the timeline for the approval of an investigational product containing the same drug substance. Based on discussions at a workshop hosted by the Bill & Melinda Gates Foundation in December 2020, it appears feasible to apply exposure-bracketing to develop novel contraceptive products using well-characterized drugs.</p></div>","PeriodicalId":10655,"journal":{"name":"Contraception: X","volume":"4 ","pages":"Article 100072"},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590151622000016/pdfft?md5=15f629b087d4947747c8ef99c9336ca6&pid=1-s2.0-S2590151622000016-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Application of exposure bracketing to streamline the development of contraceptive products\",\"authors\":\"Joshua Brown , Tamra Goodrow , Dan Hartman , Justin L. Hay , Kevin Hershberger , Susan Hershenson , Douglas McNair , Bethany Matthews , Mark A. Milad , Stephan Schmidt , Kirsten M Vogelsong , Ping Zhao\",\"doi\":\"10.1016/j.conx.2022.100072\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of such products traditionally follow a conventional paradigm that includes large Phase 3 clinical trials to evaluate efficacy (pregnancy prevention) and safety of the investigational product. Exposure-bracketing is a concept that applies known pharmacokinetics and pharmacodynamics of a drug substance to inform its safe and efficacious use in humans. Several therapeutic areas have applied this concept by leveraging established drug concentration-response relationships for approved products to expedite development and shorten the timeline for the approval of an investigational product containing the same drug substance. Based on discussions at a workshop hosted by the Bill & Melinda Gates Foundation in December 2020, it appears feasible to apply exposure-bracketing to develop novel contraceptive products using well-characterized drugs.</p></div>\",\"PeriodicalId\":10655,\"journal\":{\"name\":\"Contraception: X\",\"volume\":\"4 \",\"pages\":\"Article 100072\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2590151622000016/pdfft?md5=15f629b087d4947747c8ef99c9336ca6&pid=1-s2.0-S2590151622000016-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contraception: X\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2590151622000016\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contraception: X","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2590151622000016","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Application of exposure bracketing to streamline the development of contraceptive products
Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of such products traditionally follow a conventional paradigm that includes large Phase 3 clinical trials to evaluate efficacy (pregnancy prevention) and safety of the investigational product. Exposure-bracketing is a concept that applies known pharmacokinetics and pharmacodynamics of a drug substance to inform its safe and efficacious use in humans. Several therapeutic areas have applied this concept by leveraging established drug concentration-response relationships for approved products to expedite development and shorten the timeline for the approval of an investigational product containing the same drug substance. Based on discussions at a workshop hosted by the Bill & Melinda Gates Foundation in December 2020, it appears feasible to apply exposure-bracketing to develop novel contraceptive products using well-characterized drugs.
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