Evidence map›Paper›PMID 32757103›Full record

ArticleClinical pharmacokinetics2020

Innovative Approaches for Pharmacology Studies in Pregnant and Lactating Women: A Viewpoint and Lessons from HIV.

Ahizechukwu C Eke, Adeniyi Olagunju, Brookie M Best, Mark Mirochnick, Jeremiah D Momper, Elaine Abrams, Martina Penazzato, Tim R Cressey, Angela Colbers

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 25 citations in OpenAlex.

  1. Obstetric pharmacogenomics.Journal of basic and clinical physiology and pharmacology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 6 countries.

Ahizechukwu C EkeDivision of Maternal-Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, 600N Wolfe Street, Phipps 215, Baltimore, MD, 21287, USA.
Adeniyi OlagunjuFaculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Nigeria.
Brookie M BestUniversity of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, CA, USA.
Mark MirochnickBoston University School of Medicine, Boston, MA, USA.
Jeremiah D MomperUniversity of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, CA, USA.
Elaine AbramsMailman School of Public Health, Columbia University, New York, NY, USA.
Martina PenazzatoHIV, Hepatitis and STI Department, World Health Organization, Geneva, Switzerland.
Tim R CresseyDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Angela ColbersDepartment of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. Angela.colbers@radboudumc.nl.ORCID http://orcid.org/0000-0002-7644-1123
University of California San Diego · USColumbia University · USHarvard University · USJohns Hopkins University · USRadboud University Nijmegen · NLUniversity of Liverpool · GBWorld Health Organization · CH

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Understanding Medication Adherence Benchmarks, Safety and Pharmacometrics of Novel Antiretrovirals in Pregnant Women Living with HIV.K23HD104517 · NICHD · JOHNS HOPKINS UNIVERSITY · PI EKE, AHIZECHUKWU C. · 2020 to 2024
$857k
NIAID NIH HHS P30 AI094189NICHD NIH HHS K23 HD104517Wellcome Trust 204776/Z/16/ZWorld Health Organization 001
6 · The paper itself

Abstract

Medication use during pregnancy in the absence of pharmacokinetic and safety data is common, particularly for antiretrovirals, as pregnant women are not usually included in clinical trials leading to drug licensure. To date, data are typically generated through opportunistic pregnancy studies performed in the postmarketing setting, leading to a substantial time-lag between initial regulatory approval of a drug and availability of essential pregnancy-specific pharmacokinetic and safety data. During this period, health care providers lack key information on human placental transfer, fetal exposure, optimal maternal dosing in pregnancy, and maternal and fetal drug toxicity, including teratogenicity risk. We discuss new approaches that could facilitate the acquisition of these critical data earlier in the drug development process, aiding clinicians and patients in making informed decisions on drug selection and dosing during pregnancy. An integrated approach utilizing multiple novel methodologies (in vitro, ex vivo, in silico and in vivo) is needed to accelerate the availability of pharmacology data in pregnancy and lactation.

Indexed as

HIV InfectionsLactationPregnancyAnti-HIV AgentsBreast FeedingFemaleHumansPlacentaAnti-HIV Agents

Identifiers

PMID32757103
PMCPMC7550310
OpenAlexW3046957359

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.