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Systematic Review: Maternal-to-Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines

11 February 2026

Read the full paper here Abstract: This review evaluates the available pharmacokinetic data on the plasma-to-breastmilk transfer of first- and second-line T2DM drugs against available clinical guideline recommendations. A list of drug therapies for treating T2DM was generated from national and international clinical guidelines. A systematic search of research articles reporting human plasma and breastmilk drug concentrations was conducted in Scopus, PubMed, Google Scholar, and LactMed® in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies evaluating breastmilk drug transfer in T2DM, with fully accessible abstract and main text reported in English, were included. Study quality was evaluated using the ClinPK checklist. Authors evaluated clinical guideline recommendations on the use of T2DM drugs in lactation and the basis upon which such recommendations were made. Only 5 out of 20 drugs (metformin, glyburide, glipizide, tolbutamide, and semaglutide) have clinical data on plasma-to-breastmilk transfer. Metformin and tolbutamide were detectable in maternal plasma and breastmilk. Half (51.7%) of guideline recommendations provide explicit guidance. Only 4.4% of recommendations were based on clinical evidence. Over half (57.8%) of recommendations were accessible online, and most guideline recommendations (78%) were against the use of antiglycemic agents while breastfeeding. The scarce clinical evidence to guide T2DM drug therapy during breastfeeding available has several design and methodological limitations. Published recommendations remain largely inconsistent, thus perpetuating uncertainty in the use of T2DM drug therapies in lactation. Addressing knowledge gaps is critical in developing clinical consensus to optimize T2DM drug therapy among breastfeeding mothers.

Review Paper: Treating Pregnant and Lactating Women: Insights from Clinical Pharmacology

26 January 2026

Read the full paper here Abstract: Pregnant and lactating women have historically been excluded from clinical trials, limiting data on drug pharmacokinetics, safety, and efficacy in these populations. Recent legislative frameworks have catalyzed efforts to include these populations in research. Quantitative pharmacology approaches such as PBPK support optimized trial designs, safer dosing regimens, and ethical research frameworks. Emerging technologies further enhance insights drug exposures in mother-infant dyads

Highlights from Pharmacometrics Africa at SCOMRA 2025

12 January 2026

Pharmacometrics Africa is proud to have been well-represented at the Scientific Conference on Medical Product Regulation in Africa (SCoMRA) 2025. Many of our capacity building efforts were highlighted by team members and collaborators through presentations that helped showcase progress and our involvement in strengthening the regulatory sciences in Africa. Strengthening Dossier Assessment Competencies to Accelerate Regulatory Harmonisation in Africa Stephanie Leigh (University of Witwatersrand) presented on the PMX Africa-led university-certified programme designed to strengthen clinical dossier assessment competencies across African national regulatory authorities. Her talk highlighted the continent’s capacity gaps and outlined how this 14-week distance-learning course—co-created by regulators, academia and global partners—has already trained more than 140 assessors from 10 countries. By combining competency-based education, case studies, practical evaluations and a Train-the-Trainer model, the initiative is building sustainable regulatory expertise, advancing reliance practices, and accelerating progress toward regulatory harmonisation across Africa. Arlo & Me: The Case for Open Access Regulatory Learning Opportunities At the conference, PMX Africa collaborator Gabriel McClelland (McClelland Creative) presented a compelling look at how ARLO — Access to Regulatory Learning Opportunities — can transform the way regulatory scientists discover and share knowledge. Drawing on platform insights and real-world examples, he highlighted ARLO’s ability to curate global learning resources using filters such as Global Benchmarking Tool (GBT) categories, content type, and region, while also addressing the current challenge: the abundance of high-value educational content that remains inaccessible simply because it is not shared. Gabriel urged organisations and individuals to record their expertise, make learning assets accessible,

Research Paper: Model-based evaluation of the interaction between ritonavir-boosted atazanavir and rifampicin in Ugandan adults with HIV

23 December 2025

Read the full paper here Abstract: The DERIVE study (NCT04121195) recruited Ugandan adults with HIV (not TB) on ATV/r-based second-line antiretroviral therapy, and collected intensive plasma and PBMC pharmacokinetic samples during four visits with a sequential dose-escalation design. ATV/r plasma and PBMC concentrations were analysed with population pharmacokinetic modelling in NONMEM.

Research Paper: Population pharmacokinetics of levofloxacin in breastmilk in patients with rifampicin-resistant tuberculosis

23 December 2025

Read the full paper here Abstract: Levofloxacin is a widely used antibiotic included in rifampicin-resistant tuberculosis (RR-TB) treatment. Data describing levofloxacin concentrations in breastmilk and infant exposure are limited. We analysed data from two South African studies of breastfeeding women receiving levofloxacin (750–1000 mg daily) for RR-TB. Plasma and breastmilk samples were collected over eight hours, ≥5 weeks postpartum. A single plasma sample was obtained from breastfed infants. Twenty women contributed paired plasma-breastmilk samples, 15 plasma concentrations from breastfed infants were available. Using nonlinear mixed-effects modelling, levofloxacin equilibrated rapidly between plasma and breastmilk (7.50 min half-life; 95% CI: 3.89–11.5), with a breastmilk: plasma ratio of 1.46 (95% CI: 1.40–1.52). The relative infant dose through breastfeeding was 6–8% of the recommended 15–20 mg/kg/day adult and paediatric dose, confirmed by low (but detectable) concentrations in some infants. It is unclear whether these low infant concentrations may be prophylactic or instead contribute to the development of drug resistance.

Upcoming Webinar: Fundamentals of Population Pharmacokinetic (PopPK) Modelling, Part IV

10 October 2025

About this Series The Pharmacometrics Africa (Nigeria Chapter) Webinar Series is designed to provide a structured learning experience on PBPK and Population Pharmacokinetics. The series will guide participants through fundamental concepts, model development, and real-world applications. Who Should Attend? Anyone interested in learning the fundamentals of pharmacometrics and its application in medication therapy: Academics, Researchers, Postgraduate students, and Undergraduate students. About the Speaker: Dr. Ayorinde Adehin Ayorinde is a Scientist at the Department of Clinical Pharmacology at the Mahidol OxfordTropical Medicine Research Unit (MORU) in Bangkok. With a background in Biochemistryand Pharmaceutical Chemistry, Ayorinde’s research interests lie in pharmacokinetics and theuse of pharmacometrics tools for improved decision-making in preclinical and clinicalsettings. Before joining MORU, he was a Senior Lecturer at the Department ofPharmaceutical Chemistry, Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife,Nigeria. Currently, he works in malaria and chagas disease, developing mathematical models that willexpand the understanding of infection-dynamics and optimise drug-use in these diseases.

Upcoming Webinar: Fundamentals of Population Pharmacokinetic (PopPK) Modelling, Part III

10 October 2025

Invitation: APT Program Final Presentations Webinar

1 October 2025

On behalf of Pharmacometrics Africa and our partners, we invite you to join the final presentations of the 2025 Applied Pharmacometrics Training (APT) program. Over the past months, fellows from MSc, PhD, and postdoctoral backgrounds across African countries have taken part in an intensive program combining theoretical learning with hands-on research. Guided by a diverse group of partners across academia and industry, participants explored the application of pharmacometrics in research, development, and clinical contexts. Each fellow has been engaged in a team research project with one of our partners, applying advanced methodologies and working in collaboration with experienced scientists. Alongside their scientific work, participants have also developed leadership and communication skills, ensuring their findings are not only robust but also effectively shared. This webinar will present the outcomes of these projects. It is an opportunity to learn about the research conducted, hear reflections from the fellows, and engage with the broader network of collaborators who have supported the program. Date: Tuesday, 14 OctoberTime: 15:00 CEST (3h)Format: Online webinar Register Here We look forward to welcoming you to this session and sharing the closing stage of this year’s program.

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