Evaluation of the bioavailability of a Tamiflu taste-masking pediatric formulation using a juvenile pig model and LC-MS/MS.

To improve the palatability and increase compliance in pediatric patients, different taste-masking technologies have been evaluated to support the NIH Pediatric Formulation Initiative. This bioavailability approach combined a juvenile porcine model which represented the pediatric population, and an advanced UHPLCMS/MS method. Juvenile pigs were administered with either commercial Tamiflu or its taste-masking formulation and plasma samples were obtained from 0 to 48 h.

Analysis of agreement between specialists for the evaluation of radiological findings of necrotizing enterocolitis.

Objective: The analysis of abdominal radiography is essential for the diagnosis and management of necrotizing enterocolitis (NEC) in newborns (NB). Studies, however, show a lack of agreement among physicians in the interpretation of images. This study aims to evaluate the agreement in the radiological interpretation of the NEC between examiners from different specialties (interexaminer analysis) and between the same examiner at different times (intraexaminer analysis).

Oil-Water Emulsion Flocculation through Chitosan Desolubilization Driven by pH Variation.

Water pollution is a major concern in our modern age. The contamination of water, as a valuable and often limited resource, affects both the environment and human health. Industrial processes such as food, cosmetics, and pharmaceutical production also contribute to this problem.

A Tribute to the Pioneers of Fetal Pharmacology.

Clinical pharmacology is a branch of the field of pharmacology that evolved following the recognition that the nature, duration, and intensity of drug action depend on both the intrinsic properties of the drug and an interaction with the host to whom the drug is given. Advances in drug development have placed highly specific and extremely potent therapeutic agents in the marketplace. While these advances have progressed rapidly in adult medicine, pediatric clinical pharmacology has not kept pace and until very recently has lagged behind the research and attention paid to the proper use of therapeutic and diagnostic drugs in adults.

Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology.

Understanding all aspects of developmental biology, or pediatric ontogeny, that affect drug therapy from the fetus to the adolescent child is the holy grail of pediatric scientists and clinical pharmacologists. The scientific community is now close to being able to tie together the vast amount of information collected on pediatric ontogeny over the past 60 years. An organized knowledge base and new tools would allow us to utilize this information effectively in pediatric drug development.

Research Gaps in Primary Pediatric Hypertension.

Hypertension affects >40% of the US population and is a major contributor to cardiovascular-related morbidity and mortality. Although less common among children and adolescents, hypertension affects 1% to 5% of all youth. The 2017 Clinical Practice Guideline for the Diagnosis and Management of High Blood Pressure in Children and Adolescents provided updates and strategies regarding the diagnosis and management of hypertension in youth.

Human Ontogeny of Drug Transporters: Review and Recommendations of the Pediatric Transporter Working Group.

The critical importance of membrane-bound transporters in pharmacotherapy is widely recognized, but little is known about drug transporter activity in children. In this white paper, the Pediatric Transporter Working Group presents a systematic review of the ontogeny of clinically relevant membrane transporters (e.g.

Asthma across the ages: knowledge gaps in childhood asthma.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development convened an Asthma Group in response to the Best Pharmaceuticals for Children Act. The overall goal of the Best Pharmaceuticals for Children Act Program is to improve pediatric therapeutics through preclinical and clinical drug trials that lead to drug-labeling changes. Although significant advances have been made in the understanding and management of asthma in adults with appropriately labeled medications, less information is available on the management of asthma in children.

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version.

The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats. This paper is the second in a series that presents the update on the Safety and Toxicity of Excipients for Paediatrics ("STEP") database being developed by Eu-US PFIs, and describes the architecture data fields and functions of the database.

Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatrics Formulation Initiative: proceedings from the Second Workshop on Pediatric Formulations.

Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH) organized a workshop held in November 2011 to address knowledge gaps that limit the availability of adequate pediatric formulations. This workshop was used as a means to identify the types of research innovations needed and to stimulate research efforts designed to improve the availability of pediatric formulations and the technologies required to make these formulations.

Methods: Information for this article was gathered from the proceedings of the Second US PFI Workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Maryland, on November 1 and 2, 2011, as well as from post-workshop discussions.

The STEP (safety and toxicity of excipients for paediatrics) database. Part 1-A need assessment study.

Unlabelled: Excipients that are commonly used in adult medicines have been associated with elevated toxicological risks and safety issues in children. However, the information available on their acceptability for paediatric age groups is sparse and distributed over various sources. Hence, European (Eu) and United States (US) Paediatric Formulation Initiatives (PFIs) are collaboratively creating a STEP database.

Drug studies in newborns: a therapeutic imperative.

Although some drugs have been developed for the neonate, drug development for the least mature and most vulnerable pediatric patients is lacking. Most of the drugs are off-label or off-patent and are empirically administered to newborns once efficacy has been demonstrated in adults and usefulness is suspected or demonstrated in the older pediatric population. Few drugs are approved by the Food and Drug Administration for use in this population.

Evaluation of dosage form information provided in pediatric drug trial reports.

This report is the first to replicate the earlier findings of Standing et al and validates the inadequacy of reporting of dosage forms used in pediatric drug trials. Journal authors should provide and journal editors should require adequate dosage form information for published reports of pediatric drug trials. We also recommend that compounding pharmacists provide detailed compounding instructions to assure that extemporaneously compounded formulations can be reliably reproduced, and that quality-control data be provided to support formulation stability.

Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups.

Background: The Pediatric Formulation Initiative (PFI) is a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The PFI was established to address the issue of the lack of appropriate formulations in children and to use this activity as a means to improve pediatric formulations, as mandated by the Best Pharmaceuticals for Children Act of 2002 and 2007. The PFI began in 2005 with the formation of 3 working groups-Scientific, Economics, and Taste and Flavor.

Need for appropriate formulations for children: the national institute of child health and human development-pediatric formulations initiative, part 2.

The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations to children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulations Initiative.

Obstetric clinical pharmacology: coming of age.

Little is known about changes in drug disposition and effect during pregnancy. In this issue, which is devoted to maternal and child health, Andrew and colleagues from the University of Washington present research describing significant changes in the disposition of amoxicillin during pregnancy. The clinical significance is the potential for inadequate dosing during pregnancy of compounds that are renally cleared.

Need for appropriate formulations for children: the national institute of child health and human development-pediatric formulations initiative, part 1.

The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations in children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulation Initiative.

Criteria supporting the study of drugs in the newborn.

Background: Profound changes in the development and the maturation of neonates' organs and organ systems over variable periods of time potentially place neonates at increased risk and/or at different risks compared with adults or older children on exposure to pharmaceutical agents. Most studies of drugs in neonates focus on pharmacokinetic and pharmacodynamic end points and include insufficient numbers of patients to permit evaluation of safety. Only one fourth to one third of approved drugs have received adequate pediatric study to permit labeling for treatment of all appropriate pediatric populations.

Selected Proceedings of the NICHD/FDA newborn drug development initiative: Part II.

Background: In February 2003, the National Institute of Child Health and Human Development (NICHD) and the US Food and Drug Administration (FDA) created the Newborn Drug Development Initiative (NDDI), an ongoing program to determine gaps in knowledge in neonatal therapeutics and to explore clinical study designs for use in the newborn population. Working groups were established in 3 therapeutic areas: the central nervous, pulmonary, and cardiovascular systems. Three additional groups discussed pain control, drug prioritization, and ethics in neonatal clinical trials.

The newborn drug development initiative.

The Best Pharmaceuticals for Children Act (BPCA; Pub L 107-109) was enacted in January 2002 and will sunset in October 2007. The BPCA established processes for studying off-patent and on-patent drugs that are used in pediatric population. Although some drugs have been successfully developed for the neonate (eg, surfactant, nitric oxide), drug development for the youngest, least mature, and most vulnerable pediatric patients is generally lacking.