ArticleClinical pharmacology and therapeutics2021
Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons From HIV: A Consensus Statement.
Article in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and Safety of Antivirals in Lactating Women with Herpesviridae Infections: A Systematic Review.Viruses · 2025Pooled it
- Trial
- Pharmacokinetics of Efavirenz in Pregnancy and Postpartum with and Without First-line Tuberculosis Drugs: Results from IMPAACT P1026s.Clinical pharmacokinetics · 2026Article
- Obstetric Pharmacoethics: An ethical framework for obstetric pharmacology.European journal of obstetrics, gynecology, and reproductive biology · 2026Article
- Obstetric pharmacogenomics.Journal of basic and clinical physiology and pharmacology · 2026Review
- Advancing Maternal Health with Long-Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies.Clinical pharmacology and therapeutics · 2026Review
- A White Paper on Advancing Long-Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation.Clinical pharmacology and therapeutics · 2026Review
- Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk.British journal of clinical pharmacology · 2026Article
- Lack of Modulation of In Vivo Activity of Organic Anion Transporters 1 and 3 in Pregnancy Using Furosemide as a Probe.Journal of clinical pharmacology · 2026Article
- Long-acting Cabotegravir/Rilpivirine for Treatment of HIV During Pregnancy: A Case Series.Open forum infectious diseases · 2025Article
- Clinical lactation studies. Acting on key recommendations over the last decade.npj women's health · 2025Review
- Willingness-to-use and preferences for model-informed antenatal doses: a cross-sectional study among European healthcare practitioners and pregnant women.Frontiers in pharmacology · 2024Article
- The Impact of Inflammation on the In Vivo Activity of the Renal Transporters OAT1/3 in Pregnant Women Diagnosed with Acute Pyelonephritis.Pharmaceutics · 2023Article
- Physiologic Changes During Pregnancy and Impact on Small-Molecule Drugs, Biologic (Monoclonal Antibody) Disposition, and Response.Journal of clinical pharmacology · 2023Review
- Understanding clinical outcome measures reported in HIV pregnancy studies involving antiretroviral-naive and antiretroviral-experienced women.The Lancet. Infectious diseases · 2023Review
- Antiretroviral Therapy and Adverse Pregnancy Outcomes in People Living with HIV.The New England journal of medicine · 2023Review
- Perinatal tuberculosis-An approach to an under-recognized diagnosis.Frontiers in public health · 2023Review
- Direct antiviral agents (DAAs) and their use in pregnant women with hepatitis C (HCV).Expert review of anti-infective therapy · 2022Review
- Maternal-Fetal Drug Development: An Industry Perspective.Journal of clinical pharmacology · 2022Review
- Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin-resistant tuberculosis.British journal of clinical pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation normally becomes available years after regulatory approval of a drug. Clinicians face knowledge gaps on drug selection and dosing in pregnancy and infant exposure during breastfeeding. Physiological changes during pregnancy often result in lower drug exposures of antiretrovirals, and in some cases a risk of reduced virologic efficacy. The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network and the World Health Organization (WHO)-convened Pediatric Antiretrovirals Working Group collaboratively organized a workshop of key stakeholders in June 2019 to define key standards to generate pharmacology data for antiretrovirals to be used among pregnant and lactating women; review the antiretroviral product pipeline; describe key gaps for use in low-income and middle-income countries; and identify opportunities to undertake optimal studies allowing for rapid implementation in the clinical field. We discussed ethical and regulatory principles, systemic approaches to obtaining data for pregnancy pharmacokinetic/pharmacodynamic (PK/PD) studies, control groups, optimal sampling times during pregnancy, and pharmacokinetic parameters to be considered as primary end points in pregnancy PK/PD studies. For lactation studies, the type of milk to collect, ascertainment of maternal adherence, and optimal PK methods to estimate exposure were discussed. Participants strongly recommended completion of preclinical reproductive toxicology studies prior to phase III, to allow study protocols to include pregnant women or to allow women who become pregnant after enrolment to continue in the trial. The meeting concluded by developing an algorithm for design and interpretation of results and noted that recruitment of pregnant and lactating women into clinical trials is critical.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.