Preterm Physiologically Based Pharmacokinetic Model. Part II: Applications of the Model to Predict Drug Pharmacokinetics in the Preterm Population

Author:

Abduljalil KhaledORCID,Pan Xian,Pansari Amita,Jamei Masoud,Johnson Trevor N.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference95 articles.

1. Allegaert K. Better medicines for neonates: Improving medicine development, testing, and prescribing. Early Hum Dev. 2017;114:22–5.

2. Girardi A, Galletti S, Raschi E, Koci A, Poluzzi E, Faldella G, et al. Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit. Ital J Pediatr. 2017;43:37.

3. European Medicines Agency. Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate. 2018. https://www.ema.europa.eu/documents/scientific-guideline/concept-paper-need-revision-guideline-investigation-medicinal-products-term-preterm-neonate-revision_en.pdf. Accessed 21 Oct 2018.

4. US FDA. Guidance for Industry; General Clinical Pharmacology Considerations for Pediatric Studies for drugs and Biological Products. 2014. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-pediatric-studies-drugs-and-biological-products.

5. Leroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E, et al. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015;100:394–8.

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