Application of exposure bracketing to streamline the development of contraceptive products.

Brown, Joshua; Goodrow, Tamra; Hartman, Dan; Hay, Justin L; Hershberger, Kevin; Hershenson, Susan; McNair, Douglas; Matthews, Bethany; Milad, Mark A; Schmidt, Stephan; Vogelsong, Kirsten M; Zhao, Ping

Brown, Joshua; Goodrow, Tamra; Hartman, Dan; Hay, Justin L; Hershberger, Kevin; Hershenson, Susan; McNair, Douglas; Matthews, Bethany; Milad, Mark A; Schmidt, Stephan; Vogelsong, Kirsten M; Zhao, Ping.

Afiliação

Brown J; College of Pharmacy, University of Florida, Gainsville, FL, United States.
Goodrow T; Deer Run Regulatory Consulting, LLC, North Wales, PA, United States.
Hartman D; Bill & Melinda Gates Foundation, Seattle, WA, United States.
Hay JL; Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
Hershberger K; Certara, Princeton, NJ, United States.
Hershenson S; Bill & Melinda Gates Foundation, Seattle, WA, United States.
McNair D; Bill & Melinda Gates Foundation, Seattle, WA, United States.
Matthews B; Pharmica Consulting, Sparta, NJ, United States.
Milad MA; Milad Pharmaceutical Consulting LLC, Plymouth, MI, United States.
Schmidt S; Department of Pharmaceutics, University of Florida, Orlando, FL, United States.
Vogelsong KM; Bill & Melinda Gates Foundation, Seattle, WA, United States.
Zhao P; Bill & Melinda Gates Foundation, Seattle, WA, United States.

Contracept X ; 4: 100072, 2022.

Article em En | MEDLINE | ID: mdl-35243326

Palavras-chave

BMGF, The Bill & Melinda Gates Foundation; Contraceptive development; Exposure-bracketing; FDA, US Food and Drug Administration; LNG, Levonorgestrel; Levonorgestrel; MHRA, UK's Medical and Healthcare Products Regulatory Agency; PD, Pharmacodynamics; PK, Pharmacokinetics; Pharmacokinetics; Progestin; RWDA, real world data analyses; Real world data

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Contracept X Ano de publicação: 2022 Tipo de documento: Article

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Contracept X Ano de publicação: 2022 Tipo de documento: Article