In Vivo Experimental Design
Our guidance helps you achieve the highest statistical outcomes with minimal animal use, adhering to the 3Rs (Replacement, Reduction, Refinement) and the NHMRC Code of Practice. We aim to enhance your chances of obtaining ethical approval from regulatory bodies. ​

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In Vivo Efficacy Testing
We provide expert advice on selecting the most appropriate in vivo models and species for evaluating drug efficacy. Our goal is to:

• Optimise your studies for robust, reproducible results.

• Assess the therapeutic potential of experimental compounds to advance drug development before clinical trials.

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Preclinical Toxicology
We offer guidance on selecting suitable laboratory tests for toxicology and toxicokinetics. Our advice includes:

• Choosing industry-standard models accredited by FDA, EMA, or TGA.

• Ensuring tests are aligned with best practices for reliable results.

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Preliminary Pharmacokinetics
Enhance your understanding of your experimental compound through well-designed pharmacokinetic studies. We help you:

• Assess absorption, distribution, metabolism, excretion, bioavailability, biodistribution, and bioequivalence in relevant species.

• Tailor study designs to your specific drug and research needs.

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Compound Delivery Recommendations
We provide advice on optimal routes, dosages, and formulations to:

• Maximise drug efficacy for envisaged patient compliance.

• Minimise animal use and research costs.

• Achieve superior drug delivery outcomes while adhering to ethical research practices.

Complete Pharmacokinetic Advice Service

We provide comprehensive pharmacokinetic support for the reproducible, accurate, and precise quantification of your compound in biological fluids and animal tissues. Utilizing the latest sophisticated LCMS/MS equipment and methods, our services are tailored to meet your specific needs.

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Drug Extraction
We offer specialised method development for the extraction of peptides, small molecules, peptidomimetics, and drugs from biological tissues and fluids. Our approach maximises yields and minimises matrix binding and compound loss, ensuring accurate quantification and analysis.

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LC-MS/MS Techniques
Our expertise includes the design, development, optimisation, and validation of LCMS/MS methods for precise drug quantification in pharmacokinetic and biodistribution studies. We adhere to FDA and EMA-recommended GLP techniques to ensure the highest standards of accuracy and reliability.

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Column, Buffer, and Gradient Selection

Expert advice on selecting and optimising these critical components for your studies.

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Large Sample Runs

Guidance on managing runs of large PK sample numbers to maintain high-resolution data and improve the interpretation of drug behaviour in biological systems. Advice on when and where to include standard/calibration /reference curves, QC inclusions and solvents blanks to maximise work-flow, merit and minimise cary-over and contamination.

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Compound Stability Testing

short and long-term stability testing solutions for compounds.

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Animal Ethics Applications

We provide expert advice and editing services to help you secure rapid and frustration-free ethical clearance for your in vivo research projects. Leveraging extensive experience with various species and Australian University-based Animal Ethics Committees (AECs), we ensure your applications meet all regulatory requirements.

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In-Depth Knowledge

Extensive familiarity with the NHMRC Australian Code for the Care and Use of Animals for Scientific Purposes, NHMRC Guidelines for the Wellbeing of Animals, the 3Rs principles, and the ARRIVE guidelines.

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• Reduction: We offfer statistical models to minimise animal use yet maintain the highest possible numbers for predicted statistical inference. 

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• Replacement: We suggest non-animal, ex vivo/in vitro alternatives that reduces the welfare burden on animals by replacement with other meaning full assays, and therefore maximise the chances of obtaining ethics clearance.

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• Refinement: We aim to improve  your experimental design to maximise scientific merit while ensuring adherance and compliance to ethical standards.

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Regulatory Insight

Long-term experience as Category B member and Chairperson of AECs provides us with a deep understanding of committee dynamics and approval processes.

 

Statistical Application

Expert advice on incorporating appropriate statistical methods to comply with ethical guidelines.

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Effective Communication

Crafting lay and jargon-free language while maintaining scientific accuracy to enhance the clarity and success of your ethics applications.

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Our Goal is to facilitate a smooth, well-received approval process, ensuring your project adheres to the highest global ethical standards in animal research.