Creative Biolabs' Safety Pharmacology Study Service is a comprehensive solution designed for the preclinical assessment of new antifungal drug candidates. In the complex landscape of anti-infective drug development, identifying and characterizing potential off-target effects on vital physiological systems—such as the cardiovascular, central nervous, and respiratory systems—is crucial. These studies are a mandatory component of the Investigational New Drug (IND) application process, as mandated by international regulatory guidelines. Contact Us for a Customized Quote
Overview
Our services are specifically tailored to the unique challenges of antifungal drug development, a field where toxicity and drug-drug interactions are significant concerns. By conducting these rigorous assessments early in the preclinical phase, we help our clients de-risk their programs, avoid costly clinical trial failures, and accelerate their path to regulatory approval and, most importantly, to patients.
Detailed Scope of Services
Workflow
Service Details
Deliverables
Turnaround Time
Services
Cardiovascular System (CVS)
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In Vitro hERG Assay: This is a foundational study to assess the risk of QT interval prolongation and potential fatal arrhythmias (torsades de pointes). We use the gold-standard patch-clamp technique on a human cell line expressing the hERG ion channel.
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In Vivo Telemetry in Conscious Animals: We use telemetry devices to provide continuous, real-time monitoring of key cardiovascular parameters in conscious, unrestrained animals (e.g., rats, dogs, non-human primates). Parameters include:
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Electrocardiogram (ECG) for heart rate and rhythm analysis (QT, QTc, PR, and QRS intervals).
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Arterial blood pressure.
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Body temperature.
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Detailed arrhythmia detection.
Central Nervous System (CNS)
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Functional Observational Battery (FOB) and Irwin Test: These are comprehensive observational assessments in rodents (e.g., rats, mice) to detect a wide range of neurological and behavioral changes, including:
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Motor activity (locomotion, gait).
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Coordination and muscle tone.
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Sensory responses (e.g., startle reflex, pain response).
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Behavioral patterns (e.g., stereotypy, sedation, aggression).
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Cognitive and Motor Function Tests: We employ specialized tests such as the rotarod, elevated plus maze, and passive avoidance tests to provide a quantitative measure of CNS effects.
Respiratory System (RS)
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Whole-Body Plethysmography: A non-invasive method to measure respiratory parameters in conscious animals, including:
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Respiratory rate.
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Tidal volume.
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Minute volume.
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Inspiratory and expiratory flow.
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Invasive Respiratory Function Studies: For deeper analysis, we offer studies in anesthetized animals to measure more complex parameters like airway resistance and lung compliance.
Samples
We accept antifungal drug candidates in various forms (e.g., powder, liquid) with a detailed Certificate of Analysis (CoA) and safety data sheet. We work with both small-molecule drugs and biologics.
Deliverables
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Detailed, compliant final study report.
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All raw data is in a structured and accessible format.
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Interim reports and regular updates throughout the study.
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Expert consultation and support for regulatory inquiries.
Turnaround Time
Turnaround times are dependent on the specific study design and scope. We work efficiently to provide you with high-quality data promptly, with typical study completion ranging from 6 to 12 weeks.
Ready to discuss your project? Let us get in touch and explore how our consulting services can help you achieve your goals.
Mechanism of Action & Therapeutic Context
Antifungal drugs target specific pathways in fungal cells that are often absent or different in mammalian cells. However, off-target effects can occur, leading to adverse events. For example, many azole antifungals can cause cardiotoxicity by inhibiting human cytochrome P450 enzymes, which are also involved in the metabolism of other drugs and endogenous compounds. This highlights the critical need for a thorough safety pharmacology evaluation.
Our studies are designed to investigate these potential off-target liabilities in a controlled, predictable manner. We go beyond simple toxicology to assess the functional impact of your drug candidate on critical organ systems, providing you with a complete picture of its safety profile.
Why Partner with Us?
Specialized Expertise
Our team has extensive experience in the unique challenges of antifungal drug development and a deep understanding of regulatory requirements.
Integrated Approach
We can seamlessly integrate safety pharmacology with toxicology and other preclinical services, providing a streamlined and cost-effective drug development pathway.
State-of-the-Art Technology
We utilize advanced equipment, including multi-frequency telemetry and automated plethysmography, to generate high-fidelity, reliable data.
Customized Solutions
We don't offer a one-size-fits-all approach. We tailor our services to your specific drug, budget, and timeline.
Applications
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Predict and Mitigate Risks: Understand the safety margin of your drug candidate and identify potential toxicities before they manifest in clinical trials.
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Inform Clinical Study Design: Use preclinical data to set safe starting doses, select appropriate patient populations, and design effective monitoring protocols for human trials.
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Avoid Clinical Holds: A well-designed and executed safety pharmacology program is a key factor in securing regulatory approval for human clinical trials.
Contact us today to discuss your antifungal drug candidate and receive a personalized quote. Our team is ready to help you navigate the complexities of preclinical safety assessment and bring your life-saving therapy to market.
Your next breakthrough is just a conversation away. Let's talk about your challenges and find a custom solution together.
FAQs
What is the difference between safety pharmacology and toxicology?
Toxicology studies generally focus on dose-related organ toxicity and histopathological changes from repeated dosing. Safety pharmacology, in contrast, focuses on the acute functional effects on vital organ systems (CVS, CNS, RS) at exposures around the therapeutic range.
Which animal species do you use for your studies?
We use a variety of animal models, including rodents (rats, mice) and large animals (dogs, non-human primates), as required by regulatory guidelines and scientific rationale.
Can you perform studies on a non-GLP basis for early-stage screening?
Yes, we offer non-GLP "early de-risking" studies to help you screen compounds for potential safety liabilities before committing to full GLP programs.
