Effective and safe drug administration should be based on integrated knowledge on the evolving physiological characteristics of the patient who will receive the drug and the pharmacokinetics (PK) and pharmacodynamics (PD) of the prescribed drug. Consequently, clinical pharmacology in neonates and pregnant women is as dynamic and diverse as the patients. Mothers are exposed to drugs during pregnancy, at delivery or in postpartum, including women with comorbidity. Despite this, dosing regimens are still commonly extrapolated from regimens initially validated in adults. Infants and pregnant women warrant a focussed approach due to the physiological changes related to maturation (fetus, newborn) or pregnancy. Therefore, understanding these changes to predict exposure/effects is necessary.Modelling emerged as a promising tool to improve prediction of exposure/effects. However, these methods need further validation before implementing this approach. In addition, both effects as well as side effects may be population specific. This necessitates the validation of biomarkers (e.g., liver enzymes, renal biomarkers, and blood pressure) commonly applied in other populations, or exploration to develop, evaluate, and validate new approaches to assess drug effect or side effects (PD) in infants or pregnant women that are valid and appropriate for clinical use. Potential topics include, but are not limited to:

• Exploration of PK/PD data in infants or pregnant women compared to other populations
• Exploration of PK/PD data in infants or pregnant women within this specific subpopulation
• Development and validation of PK/PD models in neonates and pregnant women. This includes also method development (allometry, physiology-based PK, and mixed effect modelling)
• Validation of biomarkers to quantify effects or side effects in perinatal life
• Trends in pharmacovigilance in early infancy and pregnancy
• Pharmacoepidemiological trends in (illicit) drug exposure in perinatal life
• Issues related to breastfeeding
• Reports on long-term outcome, safety, and risk factors following perinatal drug exposure
• Legal, ethical, or educational initiatives to improve study feasibility
• Legal, ethical, or educational initiatives to improve knowledge diffusion on perinatal pharmacology

Before submission authors should carefully read over the journal’s Author Guidelines, which are located at http://www.hindawi.com/journals/bmri/guidelines/. Prospective authors should submit an electronic copy of their complete manuscript through the journal Manuscript Tracking System at http://mts.hindawi.com/submit/journals/bmri/pharmacology/pp/ according to the following timetable: