Obstetric patients represent a special population with respect to drug therapy. Profound anatomical and physiological changes in these populations give rise to altered drug pharmacokinetics. Yet, because of the underrepresentation of pregnant women and neonates in clinical trials, in-depth information on the drug pharmacokinetics in these populations is lacking and dosing regimens are, therefore, often extrapolated from non-pregnant adults, entailing considerable risks of sub-therapeutic or toxic drug effects for the mother, fetus and/or newborn. In recent years, tremendous efforts have been directed towards investigating drug pharmacokinetics and pharmacodynamics in obstetric populations through various approaches, including physiologically based pharmacokinetic (PBPK) models. This reflects an increased awareness of the necessity to better understand clinical pharmacology and ultimately improve pharmacotherapy in this vulnerable patient population.
The knowledge gap concerning clinical pharmacology in obstetric populations represents a major challenge for optimal drug use. Since legal and logistical reasons often preclude clinical drug trials in pregnant women and neonates, relatively little information on pharmacokinetics and pharmacodynamics in pregnant women and neonates can be gained from such trials. Additional approaches have been recently applied to leverage the data available in the obstetric population through integration in a mechanistic modeling framework (e.g. PBPK models). This facilitates the investigation and prediction of drug pharmacokinetics in pregnant women and newborns in silico thereby adding new insights to the existing body of knowledge. The goal of this article collection is to summarize clinical pharmacology in obstetric patients including relevant factors affecting drug pharmacokinetics and to showcase various facets of state-of-the-art PBPK modeling approaches in this special population.
The specific themes that the editors would like to see addressed in this article collection are the following:
• Obstetric-fetal pharmacology including physiological changes factors affecting drug pharmacokinetics
• Focus on various aspects of maternal-fetal PBPK models, e.g.:
o the current status quo, achievements and limitations of state-of-the-art pregnancy PBPK models
o the prediction and verification of maternal-fetal pharmacology through PBPK
o the selection of the right dose for pregnant women using PBPK
• Manuscripts would be predominantly review articles, complemented by original research articles, if this fits in the context of this article collection.
Obstetric patients represent a special population with respect to drug therapy. Profound anatomical and physiological changes in these populations give rise to altered drug pharmacokinetics. Yet, because of the underrepresentation of pregnant women and neonates in clinical trials, in-depth information on the drug pharmacokinetics in these populations is lacking and dosing regimens are, therefore, often extrapolated from non-pregnant adults, entailing considerable risks of sub-therapeutic or toxic drug effects for the mother, fetus and/or newborn. In recent years, tremendous efforts have been directed towards investigating drug pharmacokinetics and pharmacodynamics in obstetric populations through various approaches, including physiologically based pharmacokinetic (PBPK) models. This reflects an increased awareness of the necessity to better understand clinical pharmacology and ultimately improve pharmacotherapy in this vulnerable patient population.
The knowledge gap concerning clinical pharmacology in obstetric populations represents a major challenge for optimal drug use. Since legal and logistical reasons often preclude clinical drug trials in pregnant women and neonates, relatively little information on pharmacokinetics and pharmacodynamics in pregnant women and neonates can be gained from such trials. Additional approaches have been recently applied to leverage the data available in the obstetric population through integration in a mechanistic modeling framework (e.g. PBPK models). This facilitates the investigation and prediction of drug pharmacokinetics in pregnant women and newborns in silico thereby adding new insights to the existing body of knowledge. The goal of this article collection is to summarize clinical pharmacology in obstetric patients including relevant factors affecting drug pharmacokinetics and to showcase various facets of state-of-the-art PBPK modeling approaches in this special population.
The specific themes that the editors would like to see addressed in this article collection are the following:
• Obstetric-fetal pharmacology including physiological changes factors affecting drug pharmacokinetics
• Focus on various aspects of maternal-fetal PBPK models, e.g.:
o the current status quo, achievements and limitations of state-of-the-art pregnancy PBPK models
o the prediction and verification of maternal-fetal pharmacology through PBPK
o the selection of the right dose for pregnant women using PBPK
• Manuscripts would be predominantly review articles, complemented by original research articles, if this fits in the context of this article collection.