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Related Concept Videos

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

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Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

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Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
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Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
284
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

256
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

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Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
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Guselkumab: Pediatric First Approval.

Sheridan M Hoy1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

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|February 16, 2026
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This summary is machine-generated.

Guselkumab, targeting interleukin-23, has gained its first pediatric approvals for plaque psoriasis and psoriatic arthritis in the USA and EU. This marks a significant milestone for treating immune-mediated inflammatory diseases in children.

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Area of Science:

  • Immunology
  • Dermatology
  • Gastroenterology

Background:

  • Guselkumab targets the p19 subunit of interleukin-23, a key cytokine in immune-mediated inflammatory diseases.
  • It is approved for adults with plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.

Purpose of the Study:

  • To summarize the development milestones of guselkumab leading to its first pediatric approvals.
  • To highlight the regulatory approvals for pediatric plaque psoriasis and psoriatic arthritis.

Main Methods:

  • Review of guselkumab's development pathway.
  • Analysis of regulatory submissions and approvals in the USA and EU.

Main Results:

  • Guselkumab received US pediatric approval in September 2025 for plaque psoriasis and psoriatic arthritis (ages 6+, ≥40kg).
  • EU pediatric approval for moderate-to-severe plaque psoriasis was granted in December 2025 (ages 6+).
  • Phase III trials are ongoing for pediatric Crohn's disease and ulcerative colitis.

Conclusions:

  • Guselkumab's development has successfully extended to pediatric populations for specific immune-mediated inflammatory conditions.
  • These approvals represent a significant advancement in pediatric treatment options for plaque psoriasis and psoriatic arthritis.