Related Experiment Video

Updated: Dec 25, 2025

Author Spotlight: A Novel 3D-Printed Titanium Implant for Minimally Invasive Treatment of Hip Dysplasia in Young Dogs
08:40

Author Spotlight: A Novel 3D-Printed Titanium Implant for Minimally Invasive Treatment of Hip Dysplasia in Young Dogs

Published on: April 19, 2024

3.5K

Methylprednisolone 
(Veterinary Medicinal Products)

    Food Safety (Tokyo, Japan)
    |April 2, 2020
    PubMed

    Insights

    The Food Safety Commission of Japan assessed methylprednisolone, finding no genotoxicity concerns. An acceptable daily intake (ADI) was established at 0.0003 mg/kg bw/day for this anti-inflammatory steroid.

    Area of Science:

    • Pharmacology and Toxicology
    • Food Safety Risk Assessment

    Background:

    • Methylprednisolone is a steroidal anti-inflammatory agent.
    • Risk assessment utilized EMA (EMEA) reports and other relevant documents.

    Purpose of the Study:

    • To conduct a comprehensive risk assessment of methylprednisolone (CAS No. 83-43-2).
    • To determine an acceptable daily intake (ADI) for methylprednisolone.

    Main Methods:

    • Evaluation of available genotoxicity studies (in vitro and in vivo).
    • Assessment of adverse effects from toxicity studies.
    • Application of safety factors to establish ADI based on LOAEL.

    Main Results:

    • All available in vitro genotoxicity studies for methylprednisolone were negative.
    • Methylprednisolone is considered to have no genotoxicity relevant to human health.
    • Identified adverse effects include reduced leukocyte counts, thymic atrophy, decreased spleen weights, and hepatocyte glycogen accumulation.

    Conclusions:

    • The Food Safety Commission of Japan (FSCJ) concluded that an ADI for methylprednisolone could be specified.
    • An ADI of 0.0003 mg/kg bw/day was established using a safety factor of 1,000 on the LOAEL from a rat study.

    More Related Videos

    Adult Zebrafish Injury Models to Study the Effects of Prednisolone in Regenerating Bone Tissue07:38

    Adult Zebrafish Injury Models to Study the Effects of Prednisolone in Regenerating Bone Tissue

    Published on: October 18, 2018

    9.2K
    Murine Model of Epicutaneously-Induced Immunomodulation09:06

    Murine Model of Epicutaneously-Induced Immunomodulation

    Published on: June 24, 2025

    364

    Related Concept Videos

    Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids01:21

    Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids

    Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
    354
    Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids01:25

    Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids

    Inhaled corticosteroids (ICS) are anti-inflammatory drugs used primarily in treating persistent asthma and providing long-term maintenance. They target the bronchial mucosa, the lining of the airways, to control inflammation, a critical factor in asthma progression and exacerbation.
    ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
    1.4K
    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...
    135
    Pharmaceutical Equivalents01:26

    Pharmaceutical Equivalents

    As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
    146
    Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

    Clinically Relevant Drug Product Specifications: Methods of Establishment

    Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
    132
    Antiasthma Drugs: Methylxanthines01:24

    Antiasthma Drugs: Methylxanthines

    Theophylline, a member of the methylxanthine class of bronchodilators, has long been used in asthma management. While its exact mechanism of action is not fully understood, it is believed to have multiple effects on various cellular processes.
    Theophylline is thought to inhibit phosphodiesterase enzymes, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). This rise in cAMP and cGMP concentrations stimulates cardiac function,...
    1.5K