| Title |
Pharmacokinetics and Pharmacokinetic–Pharmacodynamic Relationships of Monoclonal Antibodies in Children
|
|---|---|
| Published in |
Clinical Pharmacokinetics, December 2014
|
| DOI | 10.1007/s40262-014-0208-4 |
| Pubmed ID | |
| Authors |
Helena Edlund, Johanna Melin, Zinnia P. Parra-Guillen, Charlotte Kloft |
| Abstract |
Monoclonal antibodies (mAbs) constitute a therapeutically and economically important drug class with increasing use in both adult and paediatric patients. The rather complex pharmacokinetic and pharmacodynamic properties of mAbs have been extensively reviewed in adults. In children, however, limited information is currently available. This paper aims to comprehensively review published pharmacokinetic and pharmacokinetic-pharmacodynamic studies of mAbs in children. The current status of mAbs in the USA and in Europe is outlined, including a critical discussion of the dosing strategies of approved mAbs. The pharmacokinetic properties of mAbs in children are exhaustively summarised along with comparisons to reports in adults: for each pharmacokinetic process, we discuss the general principles and mechanisms of the pharmacokinetic/pharmacodynamic characteristics of mAbs, as well as key growth and maturational processes in children that might impact these characteristics. Throughout this review, considerable knowledge gaps are identified, especially regarding children-specific properties that influence pharmacokinetics, pharmacodynamics and immunogenicity. Furthermore, the large heterogeneity in the presentation of pharmacokinetic/pharmacodynamic data limited clinical inferences in many aspects of paediatric mAb therapy. Overall, further studies are needed to fully understand the impact of body size and maturational changes on drug exposure and response. To maximise future knowledge gain, we propose a 'Guideline for Best Practice' on how to report pharmacokinetic and pharmacokinetic-pharmacodynamic results from mAb studies in children which also facilitates comparisons. Finally, we advocate the use of more sophisticated modelling strategies (population analysis, physiology-based approaches) to appropriately characterise pharmacokinetic-pharmacodynamic relationships of mAbs and, thus, allow for a more rational use of mAb in the paediatric population. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Spain | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 1 | 50% |
| Members of the public | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 61 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Germany | 2 | 3% |
| United States | 1 | 2% |
| France | 1 | 2% |
| Belgium | 1 | 2% |
| Unknown | 56 | 92% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 16 | 26% |
| Student > Ph. D. Student | 13 | 21% |
| Student > Master | 7 | 11% |
| Other | 5 | 8% |
| Unspecified | 1 | 2% |
| Other | 3 | 5% |
| Unknown | 16 | 26% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 18 | 30% |
| Agricultural and Biological Sciences | 9 | 15% |
| Pharmacology, Toxicology and Pharmaceutical Science | 6 | 10% |
| Mathematics | 2 | 3% |
| Immunology and Microbiology | 2 | 3% |
| Other | 6 | 10% |
| Unknown | 18 | 30% |
Attention Score in Context
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#15,312,760
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Outputs of similar age from Clinical Pharmacokinetics
#9
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