Anti‐Infective Dosing in Special Populations: Pregnancy

Abstract

MINI-REVIEW CONFLICT OF INTEREST PH and CW designed the structure for the review, performed the searches and analysed data. PH, CW, PB and KN wrote the manuscript and formulated the ideal study design for PK studies in pregnancy.

Ethical issues in therapeutic use and research in pregnant and breastfeeding women

“…Therefore, such studies represent a missed opportunity and may yield confusing or contradictory results. 70,71 In any situation where a participant provides consent for their data and samples to be used in research, the investigators have a responsibility to undertake this to the highest possible standards to maximise the understanding of the clinical question. Recognising some of these challenges, the WHO and the IMPAACT study group hosted a 2-day consultation in 2019 to define best practice for pharmacokinetic studies in pregnant and breastfeeding women with HIV, and published guidance on these aspects of study design, sample collection and data analysis.…”

“…It is increasingly recognised that datasets should be made findable, accessible, interoperable and reusable to others (FAIR), 84 but increasing awareness of these principles has not yet transformed practice. 71 It is recognised that a cultural shift is required to move towards widespread adoption of the recommendations. Whilst the principles apply to all trials and pharmacokinetic studies, there is particular importance in transparency of data arising from populations who are rare or difficult to recruit and where the research is believed to have involved some degree of risk.…”

Diversity in Clinical Pharmacology and Therapeutics

“…In our April themed issue on Therapeutic Innovations in Infectious Diseases , we published the first series of “Special Populations” reviews associated with a specific therapeutic area 21–24 and we are planning to continue this in the upcoming themed issue on Therapeutic Innovations in Neuroscience , scheduled for publication in April 2022.…”

Twice neglected? Neglected diseases in neglected populations

“…A large portion of individuals worldwide who die each year from diarrhoeal disease are children, particularly with underlying malnutrition 9,10 . It is well documented that there are often altered physiological factors that can affect drug pharmacokinetics, leading in many cases to related safety and efficacy concerns in vulnerable populations, such as those with prevalent co‐morbidities, pregnant women, and young children, particularly those with malnutrition 11,12 …”