News

[Research Paper] Clinical pharmacology considerations and drug–drug interactions with long-acting cabotegravir and rilpivirine relevant to sub-Saharan Africa

Abstract: This review aims to consider pharmacokinetic characteristics of cabotegravir and rilpivirine and describe anticipated drug–drug interactions (DDIs) with frequent concomitant medications in African settings. Relevant co-medications were identified from the WHO 2021 List of Essential Medicines. All original human and physiologically based pharmacokinetic studies published in English on PubMed, discussing DDIs with LAI cabotegravir and rilpivirine prior to April 2023, were reviewed. Read the entire paper here This featured research paper was written in part by members of our Uganda chapter. For more information on this local chapter, visit this page.

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[Research Paper] Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024

Abstract Everybody deserves access to evidence-based information to make decisions about their health. However, in many situations, clinical trial eligibility criteria mean that specific data do not exist for certain groups of individuals. These include pregnant and breastfeeding women, children, older people, those with hepatic and renal dysfunction, those with acute severe illness, and those with multiple co-morbidities and interacting medications. Resultantly, there may not be specific drug-dosing information for many patients who are treated in a clinical setting. The ASCPT2024 Dolores Shockley Lecture focused on the equitable access to research with a specific focus on clinical pharmacology studies in pregnancy and breastfeeding. To ensure the safe, effective use of medication in pregnancy and breastfeeding, women should be included in clinical trials and pharmacokinetic studies when a medication is anticipated to be used in women of childbearing potential. Community groups should be involved at all stages of research to maintain transparency and trust. This ensures that local priorities are investigated, that communities understand the findings and are empowered to make evidence-based decisions about their own medication use. Principles informing the design of such studies in pregnancy and lactation are in existence. Mathematical techniques such as physiologically-based pharmacokinetic modeling and stochastic simulation and estimation can enhance study design, and population pharmacokinetic modeling be used to understand variability within and between individuals. Data should be made findable, accessible, interoperable, and reusable (FAIR). Information (and where necessary, training) regarding the use of these approaches should be provided to decision-making stakeholders such as ethics

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Pharmacometrics Course: Now in French

Pharmacometrics Africa is pleased to announce that due in large part to a massive volunteer effort we are able to begin offering our tutor-led pharmacometrics course in the French language. The first iteration of this course has already started, however the lessons learned will be integrated into our self-paced version of the same course available later this year. Our most heartfelt thanks to the volunteers that not only translated the written course content, but also watched and subtitled every lesson video into French.

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What is the Applied Pharmacometrics Training program?

The Applied Pharmacometrics Training Fellowship – Africa Region is an intensive doctoral-level fellowship program that upskills participants to conduct regulatory quality clinical pharmacology and pharmacometrics analyses that could inform decision making. The program is an effort to increase the application of model-based drug development in Africa…

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PMX Africa
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