Model-Based Pediatric Drug Formulation Development
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".
Deadline for manuscript submissions: closed (20 March 2023) | Viewed by 3311
Special Issue Editor
Interests: pediatric clinical pharmacology; pediatric drug formulations; pediatric nanotechnology; pediatric PBPK modeling; pediatric population modeling; pediatric trial design
Special Issue Information
Dear Colleagues,
The development of pediatric drugs has advanced over the past few decades due to the incentives offered by the United States Food and Drug Administration (USFDA) and European Medicines Agency (EMEA). Despite this, only a few drugs have age-appropriate pediatric formulations available for clinical use and more than 80% of pediatric prescriptions are off-label. The risks involved with off-label use include adverse drug reactions due to drug and/or excipients, lack of therapeutic efficacy due to inappropriate dosing, and lack of compliance by pediatric patients. Therefore, the development of age-appropriate pediatric drug formulations is a significant unmet need in pediatrics.
The use of mathematical modeling and simulation in drug development has seen an exponential increase in the past few decades. The number of drug approvals by USFDA and EMEA of applications containing data from mathematical modeling and simulations is rapidly increasing. The advantages of mathematical modeling and simulations are that they make optimal use of existing clinical, physiological and physicochemical data to predict the pharmacokinetics (PK) and efficacy (PD) of drugs in various populations including pediatrics. Therefore, saving time and money in avoiding unnecessary clinical trials. In pediatric drug development, the widely studied applications of mathematical modeling and simulations include pediatric trial design, pediatric dose selection, and pediatric drug–drug interaction predictions. However, the use of mathematical modeling and simulations to inform pediatric drug formulations is not widely studied and there is a significant knowledge gap in this field.
The goal of this Special Issue is to fill the knowledge gap in applications of mathematical modeling and simulations for pediatric formulation development. The research areas solicited for this Special Issue include but are not limited to topics such as the use of population PK models to identify formulation parameters responsible for PK variability of pediatric formulations, pediatric formulation optimization using in vitro in vivo correlation (IVIVC), use of mechanistic approaches such as physiologically based pharmacokinetic modeling (PBPK) to identify formulation parameters responsible for optimal PK, and use of artificial intelligence and machine learning techniques for excipient selection and toxicological evaluation of pediatric formulations.
Dr. Venkata Kashyap Yellepeddi
Guest Editor
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Keywords
- pediatric PBPK modeling
- IVIVC
- pediatric formulations
- model-informed drug design
- population PK modeling in pediatrics
- predictive analytics
- biorelevant drug dissolution
- ontogeny
- excipients
- oral dosage forms
- variability
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