Test Articles Preparation

Non-clinical studies (also known as preclinical trials) are usually composed of two types of experiments: in-vitro (experiment conducted in a laboratory tube/dish on cells, microorganisms, etc.) and in-vivo (experiments in/on a living organism). The data gained from these studies is then used to assess the safety of the product for human use. Preparation of a drug prototype, commonly referred to as "test articles", is required for both types of experiments.

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The non-clinical phase begins very early in the development process of a drug, with the final formulation usually still unknown. Test articles prepared at such an early stage are frequently composed of a simple mixture of the active ingredient (API) with a generic media (i.e., cream, solution, etc.). As the development process progresses, the test articles should resemble the intended clinical material, and therefore the preparation procedure should be similar to the future manufacturing process. Using the final formulation in preclinical trials can establish a safety profile that will pave the way to first-in-man trials.  

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          Tip from our scientists

The characteristics of the formulation compounds may vary between different manufacturers due to diverse synthesis processes, equipment, chemical substances, etc. Those differences may affect the types and levels of impurities and contaminations found in the formulation which in turn may affect the physical, chemical, and microbial characteristics of the drug.

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Using the same compounds for both test articles preparation and Clinical Trial Material (CTM) production can provide accurate information on drug safety and effectiveness. Therefore, it is recommended that manufacturers of raw materials will be chosen prior to test articles preparation.