About this Research Topic
Pharmacometrics is the science of using advanced mathematical and statistical methods based on biology, pharmacology, physiology, and knowledge of disease to quantify the relationships between the dose of an administered drug, its exposure (pharmacokinetics), and its clinical efficacy and safety (pharmacodynamics) in individual patients and in whole populations. This methodology has been used successfully to identify the most appropriate dosing regimen of a medicine, by describing variability between individuals that may be associated with lack of efficacy in certain patients or with toxicity in others. Regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require modelling analyses to be included in regulatory dossiers. As a result, pharmacometrics has become an integral part of modern drug discovery and development.
In low- and middle-income countries, local medicines development and regulation play an important part in providing novel treatments for infectious diseases such as HIV, TB, malaria or tropical diseases, and for highly prevalent non-communicable diseases such as malignancies or cardiovascular diseases. However, these regions are lacking highly skilled and experienced professionals in pharmacometrics.
The 3rd World Conference on Pharmacometrics (www.wcop2020.org/), to be held from 7 – 10 February 2021 in Cape Town, South Africa and hosted by the University of Cape Town and Pharmacometrics Africa under the auspices of the World Conference of Pharmacometrics Committee, will provide a forum to present and discuss recent pharmacometric data, including pharmacokinetics, pharmacodynamics, population modelling and simulation.
This Research Topic of Frontiers in Pharmacology – Pharmaceutical Medicine and Outcomes Research will address the application of pharmacometrics methodologies in medicines development, individual patient management, and medicines regulation in low- and middle-income countries. Authors of oral or poster presentations submitted at the World Conference on Pharmacometrics as well as other experts in the field are invited to contribute their experiences.
The scope of the research project will be to increase awareness of the application of pharmacometrics tools with the goal to optimize the use of medicines in certain patient population, such as children, elderly, concomitant diseases or co-medications, in low- and middle-income country settings. Manuscripts on the application of pharmacometrics in clinical research and medicines regulation, specific methodologies applied in medicines development sciences, pharmacometrics practice standards, and competency-based education and training will be invited.
Clinical studies on traditional medical products whose clinical efficacy has not been sufficiently demonstrated will not be considered for review. Meta-analysis approaches will only be accepted as a component of more general studies, where methods to produce data sets have been comprehensively reported, i.e Systematic Reviews.
Submitted manuscripts can be in the form of an Original Clinical Trial Research Publication, a Brief Research Report, a Methods Publication, or a Mini Review.
Topic Editor Goonaseelan Colin Pillai is the founder of CP+ Associates GmbH, Switzerland. The other Topic Editors declare no competing interests with regard to the Research Topic subject.
Keywords: Pharmacometrics, modelling and simulations, low- and middle-income countries, medicines development, medicines regulation
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.