Adolescent Dosing and Labeling Since the Food and Drug Administration Amendments Act of 2007

Momper, Jeremiah D.; Mulugeta, Yeruk; Green, Dionna J.; Karesh, Alyson; Krudys, Kevin; Sachs, Hari Cheryl; Yao, Lynn P.; Burckart, Gilbert J.

doi:10.1001/jamapediatrics.2013.465

Cited by 98 publications

(81 citation statements)

References 22 publications

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“…In a recent analysis, 87/92 (95%) of drug products submitted to the FDA had recommendations for equivalent dosing of adolescent and adult patients. 16 However, age was not a statistically significant determinant of exposure matching by our criteria.…”

Section: Discussionmentioning

confidence: 54%

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval

Zimmerman

Putera

Hornik

et al. 2016

Clinical Therapeutics

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Purpose Over the last decade, few novel antibiotics have been approved by the Food and Drug Administration (FDA) for pediatric use. For most anti-infective agents, including antibiotics, extrapolation of efficacy from adults to children is possible if the disease and therapeutic exposures are similar between the 2 populations. This approach reduces the number of studies required in children, but relies heavily on exposure matching between children and adults. Failures in exposure matching can lead to delays in pediatric approvals of new anti-infective agents. We sought to determine the extent of exposure matching, defined by a comparison of area under the concentration-time curve, between children and adults, for anti-infective drug products submitted to the FDA for approval. Methods We reviewed anti-infective submissions to the FDA (2002–2014) for pediatric indication. We included drug products administered via oral, intravenous, or intramuscular administration routes, and those with AUC estimates for children in available FDA reports. Our main outcome of interest was the proportion of drugs with median (or mean) pediatric AUC within 20% of the median (or mean) reported adult value. Findings We identified 29 drug products that met inclusion criteria, 14 (48%) of which had mean (or median) AUCs of all submitted age groups within 20% of that in adults. Only route of administration and drug class were associated with pediatric AUC within 20% of adult AUC. Implications Future research is needed to define criteria for and predictors of successful exposure matching of anti-infectives between children and adults.

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Section: Discussionmentioning

confidence: 54%

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval

Zimmerman

Putera

Hornik

et al. 2016

Clinical Therapeutics

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“…8 To date, all drug products for the prevention or treatment of HIV have similar pharmacokinetic and pharmacodynamic profiles in adolescents and young adults. 9 As such, the adult dose and formulation of these products generally is suitable for adolescents, although some products specify a minimum weight for the adult dose that may exclude younger adolescents with lower bodyweights. Intensive pharmacokinetic sampling is not needed in adolescents, but adolescent studies frequently include population pharmacokinetic measurements to verify dosing assumptions.…”

Section: Approaches To Adolescent Product Developmentmentioning

confidence: 99%

Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies

2017

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The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration (FDA) regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission.

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“…14,22 Enrollment should be based on histology when the tumor biology is similar between adolescents and adults and/or when the molecular target of the drug is relevant. 41 A comparison of drug dosages in adolescents and adults demonstrated that 94.5% (87/92) of drug products had identical dosage for adolescents and adults, and drug clearance in adolescents averaged 93% of adult values, 23 indicating that the same adult dosage can often be used in adolescents. A recent study sponsored by the Innovative Therapies for Children with Cancer European consortium examined adult prognostic scores in children under 18 years of age with solid tumors.…”

Section: Inclusion Of Adolescents In Adult Trialsmentioning

confidence: 99%

Bridging Adult Experience to Pediatrics in Oncology Drug Development

Leong

Zhao

Reaman

et al. 2017

The Journal of Clinical Pharma

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Pediatric drug development in the United States has grown under the current regulations made permanent by the Food and Drug Administration Safety and Innovation Act of 2012. Over 1200 pediatric studies have now been submitted to the US FDA, but there is still a high rate of failure to obtain pediatric labeling for the indication pursued. Pediatric oncology represents special problems in that the disease is most often dissimilar to any cancer found in the adult population. Therefore, the development of drug dosing in pediatric oncology patients represents a special challenge. Potential approaches to pediatric dosing in oncology patients include extrapolation of efficacy from adult studies in those few cases where the disease is similar, inclusion of adolescent patients in adult trials when possible, and bridging the adult dose to the pediatric dose. An analysis of the recommended phase 2 dose for 40 molecularly targeted agents in pediatric patients provides some insight into current practices. Increased knowledge of tumor biology and efforts to identify and validate molecular targets and genetic abnormalities that drive childhood cancers can lead to increased opportunities for precision medicine in the treatment of pediatric cancers.

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Adolescent Dosing and Labeling Since the Food and Drug Administration Amendments Act of 2007

Cited by 98 publications

References 22 publications

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval

Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies

Bridging Adult Experience to Pediatrics in Oncology Drug Development

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