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Pre‐clinical testing: Good laboratory practice and the requirements imposed by the agencies
Author(s) -
VEZINA M
Publication year - 2013
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2013.4412.x
Subject(s) - guideline , medicine , protocol (science) , context (archaeology) , preclinical testing , good laboratory practice , presentation (obstetrics) , clinical trial , clinical practice , risk analysis (engineering) , medical physics , intensive care medicine , alternative medicine , pathology , family medicine , surgery , biology , paleontology , external quality assessment , quality assurance
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.Commercial interest