| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Contraception: X, Vol 4, Iss , Pp 100072- (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2590-1516 |
| DOI: |
10.1016/j.conx.2022.100072 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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