The Use of Population Pharmacokinetics to Extrapolate Food Effects from Human Adults and Beagle Dogs to the Pediatric Population Illustrated with Paracetamol as a Test Case

To date, food-drug interactions in the pediatric population remain understudied. The current food effect studies are mostly performed in adults and do not mimic the real-life situation in the pediatric population. Since the potential benefits of food effect studies performed in pediatrics should be...

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Main Authors: Elke Gasthuys (Author), Louis Sandra (Author), Marina Statelova (Author), Maria Vertzoni (Author), An Vermeulen (Author)
Format: Book
Published: MDPI AG, 2023-12-01T00:00:00Z.
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001 doaj_8c1714c7846f401e976b48f064323f90
042 |a dc 
100 1 0 |a Elke Gasthuys  |e author 
700 1 0 |a Louis Sandra  |e author 
700 1 0 |a Marina Statelova  |e author 
700 1 0 |a Maria Vertzoni  |e author 
700 1 0 |a An Vermeulen  |e author 
245 0 0 |a The Use of Population Pharmacokinetics to Extrapolate Food Effects from Human Adults and Beagle Dogs to the Pediatric Population Illustrated with Paracetamol as a Test Case 
260 |b MDPI AG,   |c 2023-12-01T00:00:00Z. 
500 |a 10.3390/ph17010053 
500 |a 1424-8247 
520 |a To date, food-drug interactions in the pediatric population remain understudied. The current food effect studies are mostly performed in adults and do not mimic the real-life situation in the pediatric population. Since the potential benefits of food effect studies performed in pediatrics should be counterbalanced with the burden that these studies pose to the patients, alternative research strategies should be evaluated. The present study aimed to evaluate whether population pharmacokinetics (popPK) using data in beagle dogs and human adults could reliably assess food effects relevant for the pediatric population. PopPK was utilized to understand the performance of paracetamol under different dosing conditions (when the participants were fasted, with a reference meal, and with infant formula) in human adults (<i>n</i> = 8) and beagle dogs (<i>n</i> = 6) by constructing models to derive the pharmacokinetic parameters and to evaluate the food effects in both species. A two-compartment model with a single input function for the absorption phase best described the profiles of paracetamol in the beagle dogs. In the human adults, a one-compartment model with a dual input function for the absorption phase best described the data. The simulated profiles for the different dosing conditions demonstrated that both the human adults' and beagle dogs' simulations were able to acceptably describe the plasma concentration-time profiles of paracetamol observed in a representative pediatric population, which opens up perspectives on pediatric-relevant food effect predictions. However, the obtained results should be carefully interpreted, since an accurate validation of these findings was not possible due to the scarcity of the literature on observed pediatric data. 
546 |a EN 
690 |a paracetamol 
690 |a pediatrics 
690 |a beagle dogs 
690 |a adults 
690 |a food effect 
690 |a population pharmacokinetics 
690 |a Medicine 
690 |a R 
690 |a Pharmacy and materia medica 
690 |a RS1-441 
655 7 |a article  |2 local 
786 0 |n Pharmaceuticals, Vol 17, Iss 1, p 53 (2023) 
787 0 |n https://www.mdpi.com/1424-8247/17/1/53 
787 0 |n https://doaj.org/toc/1424-8247 
856 4 1 |u https://doaj.org/article/8c1714c7846f401e976b48f064323f90  |z Connect to this object online.