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Related Concept Videos

Drug Dosing: Geriatric Patients01:15

Drug Dosing: Geriatric Patients

Elderly individuals encompass a diverse population with varying degrees of age-related physiological changes. Defining the elderly presents challenges, as the geriatric population is often arbitrarily categorized as individuals older than 65. However, many individuals in this group lead active and healthy lives, with an increasing number surpassing 85 years and falling into the older elderly category. Physiological changes associated with aging impact performance capacity and homeostatic...
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Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
Factors Affecting Drug Response: Overview01:21

Factors Affecting Drug Response: Overview

When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...
Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant01:25

Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant

In patients with renal disease, dosage adjustments are necessary to maintain therapeutic plasma drug concentrations and prevent toxicity or subtherapeutic exposure. Renal impairment alters drug pharmacokinetics, especially in conditions like uremia, where changes such as prolonged elimination half-life and altered apparent volume of distribution can significantly affect drug disposition. These changes require careful modification of the dosing regimen to achieve the desired clinical...
Drug Dosage Regimen: Overview01:15

Drug Dosage Regimen: Overview

A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...

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Exploring differences in drug doses between Japan and Western countries.

F L Arnold1, M Kusama, S Ono

  • 1Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan.

Clinical Pharmacology and Therapeutics
|April 23, 2010
PubMed
Summary
This summary is machine-generated.

Japanese drug approval processes require domestic data, leading to significant international dose differences for cardiovascular and central nervous system drugs. Further analysis is needed to understand these variations.

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Area of Science:

  • Pharmacology
  • Drug regulation
  • International health

Background:

  • Japan uniquely mandates substantial domestic clinical trial data for new drug applications.
  • Globalization of approved drug doses is debated, questioning Japan's unique requirements.

Purpose of the Study:

  • To investigate international variations in maximum daily drug doses for drugs approved in Japan.
  • To compare approved doses in Japan with those in the United States and the Netherlands.

Main Methods:

  • Analysis of maximum daily doses for drugs approved in Japan (2001-2007).
  • Comparison of doses for cardiovascular system (CVS) and central nervous system (CNS) drugs marketed in Japan.
  • Examination of dose ratios between Japan, the US, and the Netherlands.

Main Results:

  • For 32% of drugs approved 2001-2007, US maximum doses were ≥2 times higher than Japan's.
  • Dose discrepancies were uncommon for antitumor, antiviral, priority-review, and orphan drugs.
  • 65% of cardiovascular drugs and 32% of central nervous system drugs had higher maximum doses in the Netherlands compared to Japan.

Conclusions:

  • Significant international differences exist in maximum approved drug doses, particularly for cardiovascular and central nervous system medications.
  • These findings highlight the need for quantitative research into the reasons behind dose variations in drug approvals.