Application of exposure bracketing to streamline the development of contraceptive products
© 2022 Bill Melinda Gates Foundation..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:4 |
|---|---|
| Enthalten in: |
Contraception: X - 4(2022) vom: 18., Seite 100072 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Brown, Joshua [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Revised 05.03.2022 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1016/j.conx.2022.100072 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM337745277 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM337745277 | ||
| 003 | DE-627 | ||
| 005 | 20231225235118.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.conx.2022.100072 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1125.xml |
| 035 | |a (DE-627)NLM337745277 | ||
| 035 | |a (NLM)35243326 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Brown, Joshua |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Application of exposure bracketing to streamline the development of contraceptive products |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 05.03.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2022 Bill Melinda Gates Foundation. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a BMGF, The Bill & Melinda Gates Foundation | |
| 650 | 4 | |a Contraceptive development | |
| 650 | 4 | |a Exposure-bracketing | |
| 650 | 4 | |a FDA, US Food and Drug Administration | |
| 650 | 4 | |a LNG, Levonorgestrel | |
| 650 | 4 | |a Levonorgestrel | |
| 650 | 4 | |a MHRA, UK's Medical and Healthcare Products Regulatory Agency | |
| 650 | 4 | |a PD, Pharmacodynamics | |
| 650 | 4 | |a PK, Pharmacokinetics | |
| 650 | 4 | |a Pharmacokinetics | |
| 650 | 4 | |a Progestin | |
| 650 | 4 | |a RWDA, real world data analyses | |
| 650 | 4 | |a Real world data | |
| 700 | 1 | |a Goodrow, Tamra |e verfasserin |4 aut | |
| 700 | 1 | |a Hartman, Dan |e verfasserin |4 aut | |
| 700 | 1 | |a Hay, Justin L |e verfasserin |4 aut | |
| 700 | 1 | |a Hershberger, Kevin |e verfasserin |4 aut | |
| 700 | 1 | |a Hershenson, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a McNair, Douglas |e verfasserin |4 aut | |
| 700 | 1 | |a Matthews, Bethany |e verfasserin |4 aut | |
| 700 | 1 | |a Milad, Mark A |e verfasserin |4 aut | |
| 700 | 1 | |a Schmidt, Stephan |e verfasserin |4 aut | |
| 700 | 1 | |a Vogelsong, Kirsten M |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Ping |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Contraception: X |d 2019 |g 4(2022) vom: 18., Seite 100072 |w (DE-627)NLM310744245 |x 2590-1516 |7 nnns |
| 773 | 1 | 8 | |g volume:4 |g year:2022 |g day:18 |g pages:100072 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.conx.2022.100072 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 4 |j 2022 |b 18 |h 100072 | ||