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Preclinical Safety Package

Normally, an NDS contains scientific data about the product s safety, efficacy, and quality. The NDS will also include the results of the preclinical and clinical studies details pertaining to the production of the drug, its packaging and labeling and information about its claimed therapeutic value, conditions for use, and side effects. [Pg.316]


See other pages where Preclinical Safety Package is mentioned: [Pg.131]    [Pg.65]    [Pg.65]    [Pg.131]    [Pg.65]    [Pg.65]    [Pg.15]    [Pg.29]    [Pg.51]    [Pg.60]    [Pg.249]    [Pg.695]    [Pg.698]    [Pg.757]    [Pg.120]    [Pg.253]    [Pg.405]    [Pg.15]    [Pg.29]    [Pg.51]    [Pg.60]    [Pg.267]    [Pg.86]    [Pg.499]    [Pg.249]    [Pg.421]    [Pg.237]    [Pg.403]    [Pg.147]    [Pg.353]    [Pg.742]    [Pg.788]    [Pg.46]    [Pg.1514]    [Pg.121]    [Pg.353]    [Pg.181]    [Pg.57]    [Pg.6]    [Pg.269]    [Pg.2010]    [Pg.301]    [Pg.120]    [Pg.17]    [Pg.161]   


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Preclinical

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