Paediatric pharmacokinetics: key considerations

被引：225

作者：

Batchelor, Hannah Katharine ^{[1
]}

Marriott, John Francis ^{[1
]}

机构：

[1] Univ Birmingham, Coll Med & Dent Sci, Sch Clin & Expt Med, Pharm Pharmacol & Therapeut, Birmingham B15 2TT, W Midlands, England

来源：

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY | 2015年 / 79卷 / 03期

关键词：

absorption; biopharmaceutics; clinical trial; paediatric drug development; paediatric; pharmacokinetics; DRUG-METABOLIZING-ENZYMES; INTESTINAL PERMEABILITY; POPULATION PHARMACOKINETICS; CLINICAL PHARMACOKINETICS; SCAVENGED SAMPLES; PRETERM INFANTS; NEWBORN-INFANT; AGE-GROUPS; CHILDREN; ONTOGENY;

D O I：

10.1111/bcp.12267

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare professionals need to be aware of anatomical and physiological changes that affect pharmacokinetic profiles of drugs to understand consequences of dose adjustments in infants and children. Pharmacokinetic clinical trials in children are complicated owing to the limitations on blood sample volumes and perception of pain in children resulting from blood sampling. There are alternative sampling techniques that can minimize the invasive nature of such trials. Population based models can also limit the sampling required from each individual by increasing the overall sample size to generate robust pharmacokinetic data. This review details key considerations in the design and development of paediatric pharmacokinetic clinical trials.

引用

页码：395 / 404

页数：10

共 99 条

[1] Using ontogeny information to build predictive models for drug elimination [J].

Alcorn, Jane ;

McNamara, Patrick J. .

DRUG DISCOVERY TODAY, 2008, 13 (11-12) :507-512

[2] ASSAY OF PARACETAMOL AND ITS METABOLITES IN URINE, PLASMA AND SALIVA OF CHILDREN WITH CHRONIC LIVER-DISEASE [J].

ALOBAIDY, SS ;

PO, ALW ;

MCKIERNAN, PJ ;

GLASGOW, JFT ;

MILLERSHIP, J .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1995, 13 (08) :1033-1039

[3] Understanding dosing: children are small adults, neonates are immature children [J].

Anderson, Brian J. ;

Holford, Nick H. G. .

ARCHIVES OF DISEASE IN CHILDHOOD, 2013, 98 (09) :737-744

[4] Metabolic characteristics of the faecal microflora in humans from three age groups [J].

Andrieux, C ;

Membré, JM ;

Cayuela, C ;

Antoine, JM .

SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY, 2002, 37 (07) :792-798

[5]

[Anonymous], 2003, Guidance for Industry Exposure-Response Relationships-Study Design, Data Analysis, and Regulatory Applications

[6]

[Anonymous], GUID IND POP PHARM

[7] Innovative study design for paediatric clinical trials [J].

Baiardi, Paola ;

Giaquinto, Carlo ;

Girotto, Silvia ;

Manfredi, Cristina ;

Ceci, Adriana .

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2011, 67 :S109-S115

[8] Physiologically Based Pharmacokinetic (PBPK) Modeling in Children [J].

Barrett, J. S. ;

Alberighi, O. Della Casa ;

Laeer, S. ;

Meibohm, B. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2012, 92 (01) :40-49

[9] Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations [J].

Bartelink, Imke H. ;

Rademaker, Carin M. A. ;

Schobben, Alfred F. A. M. ;

van den Anker, John N. .

CLINICAL PHARMACOKINETICS, 2006, 45 (11) :1077-1097

[10] Scaling factors for the extrapolation of in vivo metabolic drug clearance from in vitro data:: Reaching a consensus on values of human microsomal protein and hepatocellularity per gram of liver [J].

Barter, Zoe E. ;

Bayliss, Martin K. ;

Beaune, Philip H. ;

Boobis, Alan R. ;

Carlile, David J. ;

Edwards, Robert J. ;

Houston, J. Brian ;

Lake, Brian G. ;

Lipscomb, John C. ;

Pelkonen, Olavi R. ;

Tucker, Geoffrey T. ;

Rostami-Hodjegan, Amin .

CURRENT DRUG METABOLISM, 2007, 8 (01) :33-45

← 1 2 3 4 5 6 7 8 9 10 →