Article ; Online: Design Considerations for Pharmacokinetic Studies During Pregnancy.
Journal of clinical pharmacology
2023 Volume 63 Suppl 1, Page(s) S126–S136
Abstract: Most of the interventions performed by obstetric providers involve the administration of drugs. Pregnant patients are pharmacologically and physiologically different from nonpregnant young adults. Therefore, dosages that are effective and safe for the ... ...
Abstract | Most of the interventions performed by obstetric providers involve the administration of drugs. Pregnant patients are pharmacologically and physiologically different from nonpregnant young adults. Therefore, dosages that are effective and safe for the general public may be inadequate or unsafe for the pregnant patient and her fetus. Establishing dosing regimens appropriate for pregnancy requires evidence generated from pharmacokinetic studies performed in pregnant people. However, performing these studies during pregnancy often requires special design considerations, evaluations of both maternal and fetal exposures, and recognition that pregnancy is a dynamic process that changes as gestational age advances. In this article, we address design challenges unique to pregnancy and discuss options for investigators, including timing of drug sampling during pregnancy, appropriate selection of control groups, pros and cons of dedicated and nested pharmacokinetic studies, single-dose and multiple-dose analyses, dose selection strategies, and the importance of integrating pharmacodynamic changes into these protocols. Examples of completed pharmacokinetic studies in pregnancy are provided for illustration. |
---|---|
MeSH term(s) | Humans ; Female ; Pregnancy ; Young Adult ; Fetus ; Gestational Age ; Research Personnel |
Language | English |
Publishing date | 2023-06-14 |
Publishing country | England |
Document type | Journal Article ; Research Support, N.I.H., Extramural |
ZDB-ID | 188980-1 |
ISSN | 1552-4604 ; 0091-2700 ; 0021-9754 |
ISSN (online) | 1552-4604 |
ISSN | 0091-2700 ; 0021-9754 |
DOI | 10.1002/jcph.2238 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
More links
Kategorien
In stock of ZB MED Cologne/Königswinter
Uf I Zs.176: Show issues | Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG) |
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.