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Phase I Clinical Trials: First-in-human Studies While animal studies serve an important initial step of clinical testing, a drug must ultimately be tested on humans to evaluate its safety and efficacy in treating a disease
Dulaglutide itself has a small but real signal for elevated liver enzymes in post-marketing surveillance
It means some patients already had or were going to develop it anyway
A., Xin, G., Li, Z., Yang, J., Lane, A
Without this information, we are unable to determine whether your corrective action plan is adequate to prevent similar violations in the future," the agency added
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