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[DOI] [PubMed] [Google Scholar] 115.Novak P., Maldonado D.A.P., Novak V

Finally, an initial assessment of the phototoxic potential should be conducted based on photochemical properties of the drug and information on other members in the class, which is described in ICH S10 Photosafety Evaluation of Pharmaceuticals.10 Sponsors interested in earlier access to human data before generating a full package of preclinical safety data as listed above may consider conducing exploratory clinical trials, which, per ICH guidance,6 involve limited human exposure, have no therapeutic intent, and are not intended to examine clinical tolerability

These combined effects make DSIP a promising candidate for therapeutic interventions aimed at treating major depression, especially when linked to stress and sleep disruptions

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