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Repeat-Dose Toxicology Study Service for Antifungal Drug Research

As a leading Contract Research Organization (CRO), Creative Biolabs specializes in providing high-quality, regulatory-compliant Repeat-Dose Toxicology Study services for the global antifungal drug development industry. Our service is designed to be a cornerstone of your preclinical safety assessment program, providing the essential data required to support your Investigational New Drug (IND) application and subsequent clinical trials. We understand the unique challenges in antifungal drug development, from identifying novel targets to mitigating potential host toxicities. Our expertise ensures that your drug candidate's safety profile is thoroughly characterized, paving the way for a successful and expedited journey to market. Contact Us for a Customized Quote

Fig.1 Antifungal compounds. (Creative Biolabs Authorized)

Overview

This critical preclinical phase assesses potential organ-specific toxicities, adverse effects, and a No-Observed-Adverse-Effect Level (NOAEL) to inform clinical trial design and regulatory submissions. Leveraging state-of-the-art facilities and a team of experienced toxicologists, we provide comprehensive, compliant studies tailored to your specific drug candidate and research goals.

Detailed Scope of Services

Workflow

Fig.2 The workflow of the cytotoxicity test. (Creative Biolabs Original)

Service Details

Services
Samples
Deliverables
Turnaround Time

Services

  • Dose Range Finding (DRF) Studies: Short-duration, non-GLP studies to determine the maximum tolerated dose (MTD) and to guide dose selection for the pivotal repeat-dose study.
  • Pivotal Repeat-Dose Toxicity Studies
    • Species Selection: Standard rodent (rat, mouse) and non-rodent (dog, non-human primate) models, selected based on species-specific metabolism and relevance to human toxicology.
    • Study Duration: 14, 28, 90, or 180 days, with the duration chosen to align with the planned duration of human clinical trials, as per ICH M3(R2) guidelines.
    • Route of Administration: We accommodate all common routes, including oral (gavage, capsule, diet), intravenous, intraperitoneal, subcutaneous, and inhalation, tailored to your drug's formulation.
  • Comprehensive In-Life Monitoring & Clinical Assessments
    • Daily clinical observations and detailed physical examinations.
    • Body weight, food consumption, and water intake measurements.
    • Ophthalmic examinations.
    • Electrocardiogram (ECG) for cardiovascular safety.
    • Urinalysis for renal function assessment.
  • Extensive Necropsy & Pathology
    • Gross pathology at necropsy for visual assessment of organs and tissues.
    • Comprehensive histopathology by our experienced pathologists, including microscopic examination of a wide range of tissues to identify and grade potential toxicities.
  • Clinical Pathology & Biomarker Analysis
    • Hematology: Full blood cell counts to assess effects on the hematopoietic system.
    • Clinical Chemistry: Analysis of liver, kidney, and other organ function markers (e.g., ALT, AST, creatinine, BUN).
    • Pharmacokinetic/Toxicokinetic (PK/TK) Analysis: Sample collection and analysis to correlate drug exposure with observed toxicities, essential for establishing a reliable safety margin.
  • Immunotoxicity & Other Specialized Endpoints: We can integrate specialized assessments, such as immunotoxicity screens or cytokine analysis, to evaluate the drug's potential effects on the immune system, which is especially relevant for certain antifungal drug classes.

Samples

  • Test Article: Antifungal drug candidate (API)
  • Required Amount: Varies depending on study duration, species, and dose groups. We will provide precise requirements during the protocol design phase.
  • Required Documentation: A Certificate of Analysis (CoA) is mandatory to confirm the identity, purity, and stability of the test article. We also require a Material Safety Data Sheet (MSDS) to ensure proper handling and safety protocols.

Deliverables

  • Final, compliant study protocol.
  • In-life data, including body weight, clinical observations, and food consumption records.
  • Complete raw data sets from all clinical pathology and TK analyses.
  • Comprehensive pathology report with detailed histopathological findings and digital images.
  • A final, robust study report, formatted for direct inclusion in your IND submission package.

Turnaround Time

The completion time of the research depends on the duration of the product's life cycle. A typical 28-day study, for instance, can be completed and the final report delivered within 3-4 months from study initiation. We provide a detailed project timeline in our study proposal.

Ready to discuss your project? Let us get in touch and explore how our consulting services can help you achieve your goals.

The Mechanism of Action

Antifungal drugs target various fungal-specific pathways that are distinct from those in human cells. These mechanisms include:

  • Ergosterol Synthesis Inhibition: Azoles and allylamines inhibit enzymes involved in the synthesis of ergosterol, a key component of the fungal cell membrane.
  • Cell Membrane Disruption: Polyenes bind directly to ergosterol, creating pores that lead to cell lysis.
  • Cell Wall Synthesis Inhibition: Echinocandins target β-(1,3)-D-glucan synthase, an enzyme crucial for fungal cell wall integrity.
  • Nucleic Acid Synthesis Inhibition: Flucytosine is converted into 5-fluorouracil, which interferes with DNA and RNA synthesis.

Our toxicology studies investigate potential off-target effects of these drugs on mammalian systems, ensuring their safety profile is thoroughly understood before human trials.

Our Advantages

Unmatched Regulatory Expertise

Our toxicologists have a deep understanding of FDA, EMA, and ICH guidelines, ensuring your studies are designed and executed to meet the highest regulatory standards.

Scientific and Technical Excellence

Our team includes board-certified toxicologists (DABT) and pathologists (ACVP) with extensive experience in antifungal drug development. We employ the most advanced equipment and validated analytical methods.

Integrated Solutions

Beyond repeat-dose toxicology, we offer a full suite of preclinical services, including acute toxicity, safety pharmacology, genotoxicity, and ADME studies, providing a seamless and efficient drug development pathway.

Client-Centric Approach

We pride ourselves on being a collaborative partner. Our study directors maintain open communication with you throughout the study, providing regular updates and promptly addressing any questions.

Fig.3 In vitro analysis.

Applications

  • Preclinical Development of Novel Antifungals: From small molecules to biologics.
  • IND-Enabling Studies: Providing the necessary safety data for regulatory submission to initiate first-in-human clinical trials.
  • Combination Drug Therapies: Assessing the toxicological profile of a new antifungal in combination with other drugs.
  • Drug Repurposing: Evaluating the safety of an existing compound for a new antifungal indication.

By cooperating with us, you will be able to accelerate the research and development process of antifungal drugs with confidence and precision.

Your next breakthrough is just a conversation away. Let's talk about your challenges and find a custom solution together.

FAQs

What is the primary purpose of a repeat-dose toxicology study?

The main purpose is to evaluate the toxic effects of a drug candidate when administered repeatedly over a specified period. This helps to identify target organs for toxicity, understand the dose-response relationship, and establish a safe dose for human clinical trials.

How do you handle antifungal-specific challenges?

Our team has specific experience with antifungal classes and their known toxicities, such as nephrotoxicity with polyenes or hepatotoxicity with azoles. We design our studies to specifically monitor for these effects while also performing broad-spectrum assessments.

What happens if a toxicity is observed?

Our scientific team will work with you to understand the findings, evaluate the risk, and recommend a path forward. This may involve a more detailed mechanistic study, a different dosing regimen, or an alternative formulation.

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