Non-GLP Toxicology Study

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How to Design the best Non-GLP Toxicology Study?


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How to Design the best Non-GLP Toxicology Study?

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Toxicology Studies Good Laboratory Practice (GLP) is a set of standards for conducting toxicology studies. They define how these studies must be planned, performed, monitored, recorded, reported, and stored for future reference. However , not all toxicology studies require compliance with the GLP standards. Basic screening tests where the safety of the product is not assessed do not require GLP compliance.

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Non-GLP never indicates complete ignorance of the GLP standards, it’s only that few standards may not apply to these studies . Nevertheless, non- compliance with the GLP standards doesn’t mean you design your study poorly. Even Non-GLP studies should be carried out in a way that reflects the clinical settings, ensures the accuracy of the results and maximise your return on investment.

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Here we provide you with some quick tips to design the best and effective Non-GLP toxicology study

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1) Make sure you use an appropriate species Generally, you need two animal species to test the safety profile of a drug and one species for biologic. Make sure you fulfill this basic requirement in your study. Further , preliminary studies to identify and confirm that the pharmacological activity is the same as in humans should be completed before  animal testing .

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2) Choose the right dose or doses of your drug The science of toxicology is based on the simple principle, a relationship between the animal response and the amount of drug dose received . Toxicology studies are designed to investigate how animals react to the doses from low to high levels. The animals are examined at specific intervals for the presence or absence of drug effects such as clinical signs, changes in behavior, alterations in serum chemistries, or effects on organs and organ systems . However, to ensure you observe these effects in your toxicology studies, choose the recommended doses of drugs.

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3) For NOAEL, choose a dose with similar exposure NOAEL means “No observable adverse effect level” and is used to define the starting dose of the drug in clinical trials. If you wish to define NOAEL with your study, choose a dose that result in a similar exposure as the estimated clinically relevant dose. Doses higher than this will produce toxicity.

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4) Make your study Informative What is the main purpose of a toxicology study ? Of course, to define a safe clinical dose. But, if you think Non-GLP studies can’t accomplish this, you are mistaken . Non-GLP toxicology studies  are preliminary but can be extremely informative. If designed appropriately, their results can explain the mechanism behind the suspected toxic effect. Also , they can tell the right dosing and whether there is an acceptable safety margin to send the drug for further trials.

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Non-GLP toxicology studies should mimic the clinical setting as far as possible as the length of dosing, route of administration, the frequency of dosing, etc. You must also include the ways to monitor safety pharmacology; measure blood pressure, scan the liver and monitor any hyperglycaemic / hypoglycaemic events.

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If you follow these tips with perseverance, you can make out the most of your non-GLP toxicology study.

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