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ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies
The International Conference on Harmonization (ICH) guidance ICH E14 provides recommendations, focusing on a clinical ‘thorough QT/QT(c) (TQT) study’, to evaluate the QT liability of a drug during its development. An Implementation Working Group (IWG) was also established to assist the sponsors with...
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| Main Authors: | , |
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| Format: | Artigo |
| Language: | Inglês |
| Published: |
Blackwell Science Inc
2013
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| Subjects: | |
| Online Access: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3612714/ https://ncbi.nlm.nih.gov/pubmed/22905923 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2012.04442.x |
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