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Developmental pharmacology: A moving target
Janko Samardzic1, Karel Allegaert2, Milica Bajcetic3
1Institute of Pharmacology, Clinical Pharmacology and Toxicology, Medical Faculty, University of Belgrade, Serbia.
Insights
Pediatric drug development requires understanding how a child's age and development affect drug pharmacokinetics (PK) and pharmacodynamics (PD). Insufficient PK/PD data increases risks like incorrect dosing and adverse drug reactions in children.
Area of Science:
- Developmental pharmacology
- Pediatric drug safety
- Clinical pharmacology
Background:
- Limited availability of drugs with confirmed efficacy and safety data for pediatric and neonatal populations.
- Children's unique physiological, psychological, and developmental differences impact drug potency, efficacy, and toxicity compared to adults.
- Current pediatric pharmacotherapy faces challenges due to insufficient data on drug behavior in developing individuals.
Purpose of the Study:
- To highlight key issues in contemporary developmental pharmacology.
- To emphasize the critical role of age and development in pediatric drug pharmacokinetics (PK) and pharmacodynamics (PD).
- To underscore the necessity of integrating developmental pharmacology into pediatric drug development programs.
Main Methods:
- Review of existing literature on pediatric drug pharmacokinetics (PK) and pharmacodynamics (PD).
- Analysis of clinical and animal data on receptor ontogeny and drug response.
- Focus on the impact of physiological characteristics and clinical trial data in children.
Main Results:
- Child's age and development significantly influence drug PK processes.
- Pharmacodynamic (PD) data is less understood than PK, but receptor ontogeny shows developmental changes in drug response independent of PK.
- Absence of comprehensive PK/PD data increases the risk of medication errors and treatment failure in children.
Conclusions:
- Understanding growth and development is essential for effective pediatric drug development.
- Accurate drug dosing in children must consider physiological characteristics and PK/PD parameters derived from pediatric clinical trials.
- Integrating developmental pharmacology knowledge is crucial to improve the safety and efficacy of medicines for children.
Abstract:
The main characteristic of pediatric and neonatal pharmacotherapy still is the insufficient availability of drugs with confirmed efficacy and safety data in children. Children differ from adults in the physiological, psychological and developmental terms and this subsequently results in differences in anticipated drug potency, efficacy and toxicity. This paper is focused on the most prominent issues of the contemporary developmental pharmacology. Child's age and development can significantly affect drug pharmacokinetics (PK) processes. The dosage of drugs for children must be based on the physiological characteristics, as well as PK parameters of the drug obtained from the clinical trials with children. While knowledge about the impact of developmental changes on drug PK is increasing, information regarding pharmacodynamics (PD) is still more limited. The examples from clinical and animal data on ontogeny of receptors resulted in strong evidence for changes in drug response during development, in addition to but independent from PK alterations. In order to improve the use of medicines in children, it is essentially to know the complex processes of growth and development into the pediatric drug development programs. This is because absence of PK/PD data leads to increased risk of over- or under-dosing, adverse reactions or inefficiency.
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