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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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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

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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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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...
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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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Bioequivalence: Overview01:16

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Considerations for Biosimilar Adoption in Pediatrics: A Scoping Review.

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Limited clinical evidence hinders biosimilar uptake in children. More pediatric studies and pharmacovigilance are needed to build confidence and guide healthcare institutions in adopting biosimilars for pediatric patients.

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Area of Science:

  • Pharmacology and Therapeutics
  • Health Services Research
  • Pediatric Medicine

Background:

  • Biosimilar adoption in pediatrics lags behind adults due to limited clinical evidence and safety/efficacy uncertainties.
  • Patent expirations of biologics create opportunities for biosimilar market expansion.
  • This review addresses the need for evidence to inform pediatric healthcare institutions on biosimilar decision-making.

Purpose of the Study:

  • To identify themes influencing biosimilar adoption in pediatric healthcare settings.
  • To inform decision-making processes for pediatric institutions regarding biosimilar use.
  • To develop a policy framework for pediatric biosimilar adoption.

Main Methods:

  • Scoping review of academic and grey literature from inception to September 20, 2024.
  • Searches included OVID Medline, Embase, International Pharmaceutical Abstracts, and regulatory/HTA agency websites.
  • Included studies focused on pediatric biosimilar use and institutional decision-making; excluded non-English, industry-focused, or solely adult-indication studies.

Main Results:

  • 35 articles were included (26 pediatric-specific).
  • 14 themes emerged, categorized into substantive (evidence, cost, safety, dosage forms) and procedural (approval, interchangeability, education, monitoring) principles.
  • Themes informed a policy framework for pediatric biosimilar adoption.

Conclusions:

  • A significant health-system gap exists in pediatric biosimilar adoption.
  • Industry needs to conduct robust pediatric efficacy and safety studies pre-market.
  • Enhanced pharmacovigilance and patient registries are crucial for generating real-world evidence and building confidence.