Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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,...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Dose-Response Relationship: Potency and Efficacy01:22

Dose-Response Relationship: Potency and Efficacy

The potency of a drug is the measure of its ability to produce a biological response and can be compared by looking at the half-maximum effective concentration or EC50 values of different drugs. A lower EC50 value indicates higher potency of the drug. In the dose–response curve of two antihypertensive drugs, candesartan and irbesartan, a significant difference is observed in their EC50 values. A lower EC50 value for candesartan indicates that it is more potent than irbesartan, as it produces...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Validation of the Electrophilic Allergen Screening Assay for Detection of Key Event 1 of the Skin Sensitization Adverse Outcome Pathway.

Toxics·2026
Same author

Immune system evaluation of Echinacea Purpurea root extract in female Harlan Sprague Dawley (Hsd:Sprague Dawley SD) rats.

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association·2026
Same author

Validation of the Epi2SensA Method Using the EpiDerm™ Model for Skin Sensitization Testing Under OECD TG442D.

Toxics·2026
Same author

Provocation of occupational asthma by non-specific irritation and its relevance for the classification of chemicals as respiratory allergens: a case study of methyl methacrylate.

Regulatory toxicology and pharmacology : RTP·2026
Same author

Investigation of the potential of bisphenol A substitutes to induce allergic contact sensitization using OECD defined approaches.

ALTEX·2026
Same author

Derivation of a Point of Departure using NAMs for application in Quantitative Risk Assessment of fragrance materials.

Regulatory toxicology and pharmacology : RTP·2026

Related Experiment Video

Updated: May 12, 2026

Synthesis and Characterization of an Aspirin-fumarate Prodrug that Inhibits NFκB Activity and Breast Cancer Stem Cells
13:38

Synthesis and Characterization of an Aspirin-fumarate Prodrug that Inhibits NFκB Activity and Breast Cancer Stem Cells

Published on: January 18, 2017

Dimethylfumarate: potency prediction and clinical experience.

David A Basketter1, Ian R White, Florence G Burleson

  • 1DABMEB Consultancy Ltd, Sharnbrook MK44 1PR, UK. dabmebconsultancyltd@me.com

Contact Dermatitis
|April 17, 2013
PubMed
Summary

Dimethylfumarate (DMF) is a strong skin sensitizer. The widespread allergic contact dermatitis outbreak was caused by prolonged exposure to DMF in leather products, not just its intrinsic potency.

Related Experiment Videos

Last Updated: May 12, 2026

Synthesis and Characterization of an Aspirin-fumarate Prodrug that Inhibits NFκB Activity and Breast Cancer Stem Cells
13:38

Synthesis and Characterization of an Aspirin-fumarate Prodrug that Inhibits NFκB Activity and Breast Cancer Stem Cells

Published on: January 18, 2017

Area of Science:

  • Dermatology
  • Toxicology
  • Immunology

Background:

  • Dimethylfumarate (DMF) caused a widespread allergic contact dermatitis outbreak, termed 'toxic sofa dermatitis', due to its use as an antifungal in leather goods.
  • The outbreak highlighted the need to understand factors contributing to DMF-induced skin reactions.

Purpose of the Study:

  • To investigate if the frequency and severity of allergic contact dermatitis from DMF were related to its inherent potency or the extent of exposure.
  • To quantify the skin-sensitizing potential of DMF.

Main Methods:

  • The intrinsic skin-sensitizing potency of Dimethylfumarate (DMF) was assessed using the standard local lymph node assay (LLNA).
  • An EC3 value, indicating the concentration required for a 3-fold increase in lymphocyte proliferation, was determined as a measure of relative skin-sensitizing potency.

Main Results:

  • The EC3 value for DMF was determined to be 0.35% in dimethylformamide, classifying it as a strong, but not extreme, skin sensitizer in the mouse model.
  • This potency is comparable to that of formaldehyde, another known strong human skin sensitizer.

Conclusions:

  • The high incidence and severity of allergic contact dermatitis linked to DMF suggest that prolonged, repeated, and occlusive exposure over large skin areas, combined with its strong sensitizing ability, created conditions for an epidemic.
  • The findings underscore the critical role of exposure patterns in the development of chemical-induced allergic contact dermatitis.