Pre-clinical testing: Good laboratory practice and the requirements imposed by the agencies

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Abstract

In all countries, preclinical (nonclinical) studies are required to support testing of novel therapeutics in humans. For ocular therapeutics there is no defined guideline available from the major regulatory authorities. This combined with a wide variety of compound types and delivery systems can make it challenging to determine what nonclinical studies should be conducted to support the human clinical trials. The therapeutic indication, class of compound, species specificity and suitability, dose route, systemic exposure, whether the compound is a new molecular entity or an already approved product and the intended clinical protocol, all have an impact on the nonclinical ocular program design. This presentation will outline the types of nonclinical studies that are typically appropriate for ocular therapeutics in the context of the previously mentioned considerations and the role of Good Laboratory Practice (GLP) and regulatory agencies in the design and acceptance of these studies.

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