Abstract
The International Conference on Harmonisation (ICH) S7A guideline for safety pharmacology studies was adopted in 2000. The ICH S7A guidelines describe a core battery of studies that are to be conducted prior to first administration in humans. These studies are conducted to assess potential effects on the respiratory, cardiovascular, and central nervous systems. Due to the safety implications of results from these studies, it is recommended that such studies be conducted according to good laboratory practices (GLP).
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CITATION STYLE
Mittelstadt, S. W. (2013). Study design and statistics. In Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays, Second Edition (pp. 733–740). Springer Berlin Heidelberg. https://doi.org/10.1007/978-3-642-25240-2_29
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