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Related Concept Videos

Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
Dosage Regimen: Individualization01:24

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...
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...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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,...
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...

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Related Experiment Video

Updated: May 11, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
09:24

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Published on: August 22, 2017

[Drug package inserts--varying information for the same medicines].

Janne Guldteig Storflor1, Linn Carina Pettersen, Lars Slørdal

  • 1Avdeling for klinisk farmakologi, St. Olavs hospital, Norway.

Tidsskrift for Den Norske Laegeforening : Tidsskrift for Praktisk Medicin, Ny Raekke
|May 9, 2013
PubMed
Summary

Significant variations exist in generic medicine package inserts, potentially causing patient confusion and impacting adherence. Doctors should inform patients about these differences, assuring them of the medicines' equal therapeutic value.

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Last Updated: May 11, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Published on: August 22, 2017

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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

Published on: December 3, 2020

Area of Science:

  • Pharmaceutical Sciences
  • Patient Safety
  • Health Communication

Context:

  • Package inserts are crucial for safe and effective medication use.
  • The Norwegian Medicines Agency maintains a substitution list for generic drugs.
  • Generic medicines aim to provide equivalent therapeutic value to originator drugs.

Purpose:

  • To investigate and compare information content in package inserts of generic medicines available in Norway.
  • To identify significant differences that could cause patient worry or confusion.

Summary:

  • A study analyzed package inserts for 71 generic medicines across 17 drug classes.
  • Considerable differences were found in 76% of the analyzed drug classes.
  • Variations were most pronounced in side effect information, with frequent use of unclear medical jargon.

Impact:

  • Discrepancies in package insert information may lead to patient confusion, uncertainty, and reduced medication compliance.
  • Healthcare providers should proactively communicate potential variations in generic medicine information to patients.
  • Ensuring clear and consistent patient information is vital for maintaining trust and adherence in generic substitution programs.