Translating Clinical Pharmacology Data in Pregnancy to Evidence-Based Guideline Recommendations: Perspectives From the HIV Field. [Review]

MedStar author(s):
Citation: Journal of Clinical Pharmacology. 63 Suppl 1:S188-S196, 2023 06.PMID: 37317495Institution: MedStar Washington Hospital CenterDepartment: Obstetrics and GynecologyForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *HIV Infections | *Pharmacology, Clinical | Breast Feeding | Female | Fetus | HIV Infections/dt [Drug Therapy] | Humans | Infant | Lactation | Pregnancy | Year: 2023Local holdings: Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0091-2700
Name of journal: Journal of clinical pharmacologyAbstract: Pharmacokinetic (PK) studies in pregnant, postpartum, and breastfeeding people are critical to informing appropriate medication use and dosing. A key component of translating PK results in these complex populations into clinical practice involves the systematic review and interpretation of data by guideline panels, composed of clinicians, scientists, and community members, to leverage available data for informed decision making by clinicians and patients and offer clinical best practices. Interpretation of PK data in pregnancy involves evaluation of multiple factors such as the study design, target population, and type of sampling performed. Assessments of fetal and infant drug exposure while in utero or during breastfeeding, respectively, are also critical for informing whether medications are safe to use during pregnancy and throughout postpartum in lactating people. This review will provide an overview of this translational process, discussion of the various factors considered by guideline panels, and practical aspects of implementing certain recommendations, using the HIV field as an example. Copyright © 2023, The American College of Clinical Pharmacology.All authors: Best BM, Brooks KM, Capparelli E, Momper JD, Scott RKFiscal year: FY2023Digital Object Identifier: Date added to catalog: 2023-07-27
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 37317495 Available 37317495

Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2006

Pharmacokinetic (PK) studies in pregnant, postpartum, and breastfeeding people are critical to informing appropriate medication use and dosing. A key component of translating PK results in these complex populations into clinical practice involves the systematic review and interpretation of data by guideline panels, composed of clinicians, scientists, and community members, to leverage available data for informed decision making by clinicians and patients and offer clinical best practices. Interpretation of PK data in pregnancy involves evaluation of multiple factors such as the study design, target population, and type of sampling performed. Assessments of fetal and infant drug exposure while in utero or during breastfeeding, respectively, are also critical for informing whether medications are safe to use during pregnancy and throughout postpartum in lactating people. This review will provide an overview of this translational process, discussion of the various factors considered by guideline panels, and practical aspects of implementing certain recommendations, using the HIV field as an example. Copyright © 2023, The American College of Clinical Pharmacology.

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